January 29, 2019

Document Control Officer (DCO) Office of Pollution Prevention and Toxics (OPPT) US Environmental Protection Agency (7401M) 1200 Pennsylvania Avenue, N.W. Washington, DC 20460

SUBJECT: Additional Information for P-18-0257

Everris NA Inc. wishes to submit to EPA responses to the agency’s review of the PMN substance under P- 18-0257. We respectfully request the agency to further consider these responses which are provided with additional information to support P-18-0257.

Hi-Peak is a double salt crystal with the empirical formula K3H3(PO4)2, composed of monopotassium phosphate (MKP - KH2PO4) and dipotassium phosphate (DKP - K2HPO4) salts.

During its intended use, once dissolved in water, Hi-Peak dissociates behaving as a mixture of two known, TSCA listed compounds: monopotassium phosphate (MKP - KH2PO4) (CAS No. 7778-77-0) and dipotassium phosphate (DKP - K2HPO4) (CAS No. 7758-11-4). These two compounds, Monopotassium Phosphate (MKP) and Dipotassium Phosphate (DKP), are known as common fertilizers that are highly soluble in water and are applied to plants through watering after dissolving in water (terms P-25 and P-26 of AAPFCO, official edition, 2002). The intended use of the PMN substance as an element in Hi-Peak will be applied as an inorganic fertilizer through watering as well.

In addition to its use as a fertilizer, monopotassium phosphate (MKP - KH2PO4) and dipotassium phosphate (DKP - K2HPO4) salts are used as food additives. We refer to listings found in the FCC (Food Chemicals Codex and (EU) No 231/2012: E 340 (i) monopotassium phosphate (MKP); E 340 (ii) dipotassiumphosphate (DKP). Both also have known cosmetic uses (EU Inventory of Cosmetic Ingredients and Fragrances Decision 96/335/EC establishing INCI list and Cosmetic Ingredients/Fragrances Inventory Version 2, last update 8 May 2015).

And further, both substances are recognized as GRAS in accordance with 21 C.F.R. Part 169.110 and (21 C.F.R. Part 182.6285, and 21 C.F.R. Part 133.169 respectively. Both MKP and DKP are listed under OSPAR PLONAR list of substances/preparations used and discharged offshore which are considered to pose little or no risk to the environment (2018). Both compounds identified by their respective CAS registry numbers do not meet the criteria for classification according to the GHS (Global Harmonized System) – SDSs (See Appendix 1).

As such, and in view of the above, it can be assumed that both compounds from Hi-Peak do not present unreasonable risk to human health or the environment. This should also be the case for the aqueous mixture of Hi-Peak.

ICL 11636 Huntington Road Gallipolis Ferry, WV 25515 Tel. 304-675-1150 ext. 483 Fax. 304-675-4657 E-mail: [email protected]

ECOTOXICITY EPA stated regarding the submitted Algae inhibition study (project number: 3113/0004): "This algal test is not acceptable as it does not address the concern for eutrophication potential of the phosphoric acid". Further to this conclusion, experimental chronic ecotoxicity values were not available for assessment. Therefore, EPA has estimated the environmental hazard of this new chemical substance using both a hazard data on the new chemical substance, as well as on analogous chemicals. "Based on these estimated hazard values, EPA concludes that this chemical substance has a high environmental hazard."

Comments by Everris NA Inc.:

1. General comments regarding the composition of Hi-Peak that includes the PMN substance P-18-0257:

Hi-Peak is a double salt crystal with the empirical formula K3H3(PO4)2 as indicated by the XRD and elemental analysis provided. The Hi-Peak double salt crystal is composed of monopotassium phosphate (MKP - KH2PO4) and dipotassium phosphate (DKP - K2HPO4) salts.

Monopotassium phosphate (MKP) and dipotassium phosphate (DKP) are two known fertilizers, appearing in the TSCA list of active chemicals. Both fertilizers are highly soluble in water and are applied to plants through watering after dissolving in water. Hi-Peak (which includes the PMN substance) will be applied as a fertilizer to plants through watering as well.

The following equations represent dissolution in water of MKP and DKP (1:1) and Hi-Peak:

+ 2- - K2HPO4 + KH2PO4 3K (aq) + HPO4 (aq) + H2PO4 (aq)

Hi-Peak solubility in water equation + 2- - K3H3(PO4)2 3K (aq) + HPO4 (aq) + H2PO4 (aq)

As indicated from the equations above, both equations present the same ionic stoichiometric ratio in water. The ionic composition of MKP and DKP (1:1 mixture) is identical to the ionic composition of Hi-Peak after dissolving in water. Once applied through watering to the environment, Hi-Peak behaves exactly as a mixture of MKP and DKP (1:1 mixture).

2. The alga toxicity study was conducted in accordance with GLP standards and OECD test guideline No. 201 (2006) and OPPTS 850.5400 guideline (Algal Toxicity, Tiers I and II) in a well-reputable and experienced laboratory. The OECD 201 guideline is designed to test toxicity of the test substance to the algae organism. Eutrophication potential is not a parameter that is in the scope of the OECD 201 guideline or the OPPTS 850.5400 guideline (Algal Toxicity, Tiers I and II).

The results of the study show clearly that there is no inhibition of the alga's growth following exposure to the test substance.

ICL 11636 Huntington Road Gallipolis Ferry, WV 25515 Tel. 304-675-1150 ext. 483 Fax. 304-675-4657 E-mail: [email protected]

We believe that valid experimental results on an actual substance should always take precedence over the use of a model, on an analog substance.

Therefore, since the algal study met all the requirements of the guidelines, it is justified to use the experimental data which were generated on the PMN substance, rather than using estimated values from a computational model of another molecule (analog).

3. In the conclusions of the EcoTox studies, EPA is using EC50 and ChV calculated values to estimate toxicity of the analog to algae. These values are used for read-across instead of the experimental algal data. As was argued in the previous comment, we believe that the algae study is valid and the EC50 and NOEC of the actual study should be used.

4. It is understood by Everris NA Inc. that the presented analog values are derived from EpiSuite Software. According to EpiSuite Help guide (Overview & intro 1.2. Limitations):

"It is important to stress that EPI Suite™ is a screening-level predictive tool and cannot be used for all chemical substances. ………….. The intended application domain of EPI Suite is organic chemicals, and inorganic as well as organometallic chemicals generally can be considered outside the domain." (see attachment in Appendix 1). Therefore, to our understanding the assumptions used to justify the use of the EpiSuite model on this inorganic substance are inaccurate and not suitable.

5. According to EPA the algal test is not acceptable as it does not address the concern for eutrophication potential of the phosphoric acid. Eutrophication potential is not a parameter that is assessed by the OECD 201 guideline or by the OPPTS 850.5400 guideline (Algal Toxicity, Tiers I and II). Thus, we find this reason for rejecting the alga study unjustified. Nevertheless, we calculated the Eutrophication potential for MKP, DKP and Hi-Peak using the model: http://www.cheminfo.org/Chemistry/Eutrophication_potential/index.html The calculation shows identical values for all three substances as presented in the following table. Thus, we strongly believe that no environmental hazard is expected for Hi-Peak based on similarity to MKP and DKP.

Eutrophication potential of the three substances

Substance Eutrophication potential MKP 0.9686 DKP 0.9769 Hi-Peak 0.9727

ICL 11636 Huntington Road Gallipolis Ferry, WV 25515 Tel. 304-675-1150 ext. 483 Fax. 304-675-4657 E-mail: [email protected]

The eutrophication potential model outcome:

MKP Calculation: DKP Calculation: HiPeak Calculation:

Summary of Ecotoxicity comments: A. The Algal study submitted is valid in accordance with OECD 201 and OPPTS 850.5400 guideline (Algal Toxicity, Tiers I and II). Therefore, should be accepted. B. The EPI Suite™ is not suitable usually for inorganic substances and for this substance. It also does not predict eutrophication potential. Therefore, it should not be used instead of a valid experimental study due to lack of eutrophication. C. Eutrophication potential has been calculated in this document and should be considered in EPA's evaluation of the PMN substance in Hi-Peak. D. This substance does not pose an unreasonable risk to the environment, as it is similar to known and used fertilizers, which are also included in the OSPAR PLONOR list of substances/preparations used or discharged offshore which are considered to pose little or no risk to the environment (2018).

Human Health EPA concluded that there is low/ moderate concern for human health hazard for the chemical substance. Based on the hazard determination and available quantitative and qualitative risk information, EPA concluded the following risks for the PMN substance: • Absorption is expected to be nil through the skin and good through the lungs and GI tract (Physical Chemistry and data on phosphate salts). • Concern for kidney toxicity and lungs toxicity based on hazards identified in 2011 PPRTV document for inorganic phosphates. • Concern for eye irritation based on submitted data.

Comments by Comments by Everris NA Inc.: 1. General comment regarding choice of the analog: Phosphoric acid is used by EPA as the analog for oral exposures. We believe that the use of phosphoric acid as an analog to Hi-Peak is inaccurate based on the following argument: Phosphoric acid has three acidic protons (H3PO4). The first proton dissociate from phosphoric acid is highly acidic with pKa of 1.8 (see pKa table in appendix 1). This

ICL 11636 Huntington Road Gallipolis Ferry, WV 25515 Tel. 304-675-1150 ext. 483 Fax. 304-675-4657 E-mail: [email protected]

acidity of phosphoric acid is comparable to acidity of sulfuric acid (H2SO4 dissociation of the first proton (pKa 1.82). For these kinds of acids, an acute effect is expected by exposure through oral such as irritation or scorching. Hi-Peak is an inorganic salt which does not contain phosphoric acid - (H3PO4). Hi-Peak is a derivative salt of phosphoric acid containing the following ions H2PO4 and 2- HPo4 . Thus, we believe that the use of phosphoric acid as an analog to Hi-Peak is inappropriate.

2. EPA: "Absorption is expected to be good through lungs" and "Particle size is unknown. "

Everris NA Inc. comment: A Particle size distribution study according to GLP standards and OECD testing guideline no. 110 is available and was provided upon PMN submission (Sieve Analysis and Dust Content, REPORT NUMBER: 08).

The particle size data acquired for the test item is shown in the following table:

75.9% of the particles are not inhalable at all. Respirable particle concentration in the product is negligible, not more than 0.3%. From the above study results, it can be concluded that lungs are not a target organ, as respiration is not an exposure route.

3. EPA: "Absorption is expected to be good through GI"

Everris NA Inc. comment: Inorganic phosphates exhibit similar toxicological properties. All the tested inorganic phosphates are practically non-toxic following acute oral, dermal, and inhalation exposures. In sub-chronic and chronic studies, high doses of the inorganic phosphates did not cause severe toxicological effects. In those studies, the common effect seen was renal effects, particularly calcification of the kidney, at high doses. This effect is not a direct effect of the inorganic phosphates, but rather an indirect effect of increased calcium excretion at high doses of inorganic phosphates as part of the physiological regulatory mechanism (2011 PPRTV document for inorganic phosphates). Therefore, although absorption through the GI is predicted to be good, the effect on the kidneys is expected only at high doses and not as a direct hazard effect of the substance.

ICL 11636 Huntington Road Gallipolis Ferry, WV 25515 Tel. 304-675-1150 ext. 483 Fax. 304-675-4657 E-mail: [email protected]

4. EPA: "Potential risks were identified for workers for eye irritation based on the submitted data. This risk can be mitigated if exposures can be controlled using appropriate PPE, including eye protection."

Everris NA Inc. comment: Risk to workers is controlled using the following PPE to control exposure, as described in the substance SDS section 8.2 ('Exposure controls'):

-Respiratory protection: Use suitable respiratory protective device in case of insufficient ventilation. ·Protection of hands: Protective gloves ·Eye protection: Safety glasses -Body protection: Light weight protective clothing

Summary of Human Health comments: A. Phosphoric acid is not an appropriate analog for comparison to Hi-Peak, since it is a strong acid, unlike Hi-Peak which is a derivative salt of phosphoric acid. B. Particle size data was submitted. Results show that respiration is not an expected route of exposure. C. Absorption through the GI is predicted to be good, the effect on the kidneys is expected only at high doses and not as a direct hazard effect due to the substance. D. Eye irritation hazard is controlled by the recommended PPE in the product SDS and label. E. We believe this substance presents no unreasonable risk to human health, as is exemplified by the fact that both constituents of Hi-Peak (MKP, DKP) are known food and cosmetic additives, recognized as GRAS.

Everris NA Inc. would kindly appreciate if EPA would consider the additional information we have provided in the review of the PMN chemical substance. If there are any additional questions, please do not hesitate to contact me either via phone ((304) 675-1150 ext. 483) or e-mail (kenneth.howell@icl- group.com).

Sincerely,

Levi Howell Regulatory Affairs Specialist ICL-IP America Inc.

ICL 11636 Huntington Road Gallipolis Ferry, WV 25515 Tel. 304-675-1150 ext. 483 Fax. 304-675-4657 E-mail: [email protected]

References • AAPFCO, official edition, 2002. • FCC (Food Chemicals Codex and (EU) No 231/2012: E 340 (i) MONOPOTASSIUM PHOSPHATE (MKP); E 340 (ii) DIPOTASSIUM PHOSPHATE (DKP). • 96/335/EC establishing INCI lIst and CoIng Ingredients/Fragrances Inventory version 2. • 21 C.F.R. Part 169.110 and (21 C.F.R. Part 182.6285, and 21 C.F.R. Part 133.169. • OSPAR Plonor list of substances/preparations used as discharged offshore which are considered to pose little to no risk to the environment (2016). • OECD test guideline No. 201: "Freshwater Alga and Cyanobacteria, Growth Inhibition Test". Adopted 23 March 2006. • Ecological Effects Test Guidelines OPPTS 850.5400 guideline (Algal Toxicity, Tiers I and II). April 1996 • EPI Suite™ V.4 Help guide (Overview & intro 1.2. Limitations). • OECD testing guideline no. 110: "Particle Size Distribution/Fibre Length and Diameter Distributions". Adopted 12 May 1981. • 2011 PPRTV document for inorganic phosphates.

ICL 11636 Huntington Road Gallipolis Ferry, WV 25515 Tel. 304-675-1150 ext. 483 Fax. 304-675-4657 E-mail: [email protected]

Attachments

1.) Certificate of Specification; Hi-Peak; December 15, 2015. 2.) XRD Spectra; Hi-Peak 3.) Equilibrium Constants For Acids and Bases in Aqueous Solutions; Web-Resource Citation 4.) Safety Data Sheet; Dipotassium Phosphate; ICL 5.) Safety Data Sheet; Monopotassium Phosphate: ICL 6.) Chemical Report; Dipotassium Phosphate 7.) Chemical Report; Monopotassium Phosphate 8.) AAPFCO Citation for MKP and DKP 9.) 2018 PLONOR Report for MKP and DKP

ICL 11636 Huntington Road Gallipolis Ferry, WV 25515 Tel. 304-675-1150 ext. 483 Fax. 304-675-4657 E-mail: [email protected]

December 15, 2015

CERTIFICATE OF SPECIFICATION

HIPEAK 0-45-45

Rotem Amfert Negev Ltd. certifies that HIPEAK 0-45-45 will meet the following analysis:

Parameter Unit Guaranteed values Phosphorus (P2O5) % w/w 45% min

Potassium (K2O) % w/w 45% min

Bulk density kg/l 2.399, at 20 °C

Yours faithfully,

Benny Ron

QA Manager ICL Rotem

Equilibirum Constants for Acids and Bases in Aqueous Solutions Page 1 of 2

Equilibrium Constants For Acids and Bases in Aqueous Solution Return

Ka Ionization (or dissociation constant for an acid A (charged or otherwise) = + - +1 -1 equilibrium constant [H ][B ]/[A] for A <===> H + B . Likewise,Kb, the ionization constant (or dissociation constant of a base B = equilibrium constant [A+][OH-]/[B] for B<===> A+1 + OH-1

Acid or Ion Equilibrium (all in aqueous solution) Ka pKa pKb Kb +1 -1 Perchloric HClO4 <=====> H + ClO4 very large ------Hydroiodic HI <=====> H+1 + I-1 very large ------Hydrobromic HBr <=====> H+1 + Br-1 very large ------Hydrochloric HCl <=====> H+1 + Cl-1 very large ------+1 -1 Sulphuric H2SO4 <=====> H + HSO4 very large ------+1 -1 Nitric HNO3 <=====> H + NO3 40 1.6 ------+1 -1 -14 Chromic(VI) H2CrO4 <===> H + HCrO4 10 1.00 14.00 1.0 x 10 +1 -1 -1 -14 Trichloroethane CCl3CO2H <=> H + CCl3CO2 2.3 x 10 0.64 13.36 4.37 x 10 +1 -1 -2 -14 Iodic(V) HIO3 <=====> H + IO3 1.7 x 10 0.78 13.22 6.03 x 10 +1 -1 -2 -13 Oxalic HO2CCO2H <==> H + HOOCCOO 5.4 x 10 1.27 12.73 1.86 x 10 +1 -1 -2 -13 Dichloroethanoic CHCl2COOH <==> H + CHCl2COO 5.0 x 10 1.30 12.70 2.00 x 10 +1 -1 -2 -13 Sulphurous H2SO3 <=====> H + HSO3 1.5 x 10 1.82 12.18 6.61 x 10 +1 -1 -2 -13 Phosphoric H3PO4 <=====> H + H2PO4 1.6 x 10 1.80 12.20 6.31 x 10 +1 -1 -2 -12 Chloric(III) HClO2 <=====> H + ClO2 1.0 x 10 2.00 12.00 1.00 x 10 -1 +1 2- -2 -12 Hydrogen sulphate HSO4 <=====> H + SO4 1.0 x 10 2.00 12.00 1.00 x 10 +1 -1 -2 -12 Phosphoric(V) H3PO4 <=====> H + H2PO4 7.9 x 10 2.10 11.90 1.26 x 10 3+ +1 2+ -3 -12 Iron(III) ion Fe(H2O)6 <==> H + Fe(H2O)5(OH) 6.0 x 10 2.22 11.78 1.66 x 10 +1 -1 -3 -12 Hydrogen telluride H2Te <=====> H + HTe 2.3 x 10 2.64 11.36 4.37 x 10 +1 -1 -3 -12 Chloroethanoic CH2ClCOOH <==> H + CH2ClCOO 1.3 x 10 2.89 11.11 7.76 x 10 +1 +1 -4 -11 Citric H3C6H5O7 <=====> H + H2C6H5O7 7.1 x 10 3.15 10.85 1.41 x 10 +1 -1 -4 -11 Nitrous HNO2 <=====> H + NO2 7.1 x 10 3.15 10.85 1.41 x 10 Hydrofluoric HF <=====> H+1 + F-1 5.6 x 10-4 3.25 10.75 1.78 x 10-11 +1 -1 -4 -11 Hydrogen selenide H2Se <=====> H + HSe 1.7 x 10 3.77 10.23 5.89 x 10 Methanoic (Formic) HCOOH <====> H+1 + HCOO-1 1.6 x 10-4 3.80 10.20 6.31 x 10-11 Chromic ion 3+ +1 2+ -4 -11 Cr(H2O)6 <=> H + Cr(H2O)5(OH) 1.5 x 10 3.82 10.18 6.61 x 10 +1 -1 -4 -11 Lactic C3H6O3 <=> H + C3H5O3 1.2 x 10 3.92 10.08 8.32 x 10 +1 -1 -5 -10 Barbituric HC4H3N2O3 <===> H + C4H3N2O3 9.8 x 10 4.01 9.99 1.02 x 10 +1 -1 -5 -10 Ascorbic C6H8O6 <=====> H + C6H7O6 7.9 x 10 4.10 9.90 1.26 x 10 +1 -1 -5 -10 Benzoic C6H5COOH <==> H + C6H5COO 6.3 x 10 4.20 9.80 1.59 x 10 Hydrogen oxalate HOOCCOO-1 <=> H+1 + 1-OOCCOO-1 5.4 x 10-5 4.27 9.73 1.86 x 10-10 +1 +1 -5 -10 Phenylammonium ion C6H5NH3 <=====> H + C6H5NH2 2.0 x 10 4.70 9.30 5.01 x 10 +1 -1 -5 -10 Ethanoic CH3COOH <==> H + CH3COO 1.7 x 10 4.77 9.23 5.89 x 10 +1 -1 -5 -10 n-Butanoic C3H4COOH <===> H +C3H4COO 1.5 x 10 4.82 9.18 6.61 x 10 +1 -1 -5 -10 Propanoic C4H5COOH <==> H + C4H5COO 1.3 x 10 4.89 9.11 7.76 x 10 3+ +1 2+ -5 -9 Aluminum ion Al(H2O)6 <==> H + Al(H2O)5(OH) 1.0 x 10 5.00 9.00 1.0 x 10 -1 +1 2- -7 -8 Dihydrogen phosphite H2PO3 <===> H + HPO3 6.3 x 10 6.21 7.79 1.62 x 10

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+1 -1 -7 -8 Carbonic H2O + CO2 <=====> H + HCO3 4.5 x 10 6.35 7.65 2.24 x 10 -1 +1 2- -7 -8 Hydrogen chromate HCrO4 <==> H + CrO4 3.2 x 10 6.50 7.50 3.16 x 10 +1 -1 -8 -7 Hydrogen sulphide H2S <=====> H + HS 8.9 x 10 7.05 6.95 1.12 x 10 -1 +1 2- -8 -7 Hydrogen sulphite HSO3 <==> H + SO3 6.2 x 10 7.21 6.79 2.0 x 10 -1 +1 2- -8 -7 Dihydrogen phosphate H2PO4 <===> H + HPO4 6.2 x 10 7.21 6.79 2.0 x 10 Hypochlorous HClO <=====> H+1 + ClO-1 3.7 x 10-8 7.43 6.57 3.0 x 10-7 +1 -1 -8 -7 Telluric H5TeO6 <=====> H + H4TeO6 2.0 x 10 7.70 6.30 5.02 x 10 Hypobromous HBrO <=====> H+1 + BrO-1 2.1 x 10-9 8.68 5.32 4.8 x 10-6 +1 -1 -10 -5 Boric H3BO3 <=====> H + H2BO3 5.8 x 10 9.24 4.76 1.74 x 10 +1 +1 -10 -5 Ammonium ion NH4 <=====> H + NH3 5.6 x 10 9.25 4.75 1.78 x 10 Hydrocyanic HCN <=====> H+1 + CN-1 4.9 x 10-10 9.31 4.69 2.04 x 10-5 +1 -1 -10 -5 Silicic H2SiO3 <=====> H + HSiO3 1.3 x 10 9.89 4.11 7.69 x 10 +1 +1 -10 -5 Ethane-1,2-diammonium C2H9N2 <===> H + CH3NHCH2NH2 1.3 x 10 9.89 4.11 7.69 x 10 +1 -1 -10 -5 Phenol C6H5OH <=====> H + C6H5O 1.28 x 10 9.88 4.12 7.81 x 10 +1 +1 -11 -4 Butylammonium C4H9NH3 <===> H + C4H9NH2 5.0 x 10 10.30 3.70 1.0 x 10 -1 +1 2- -11 -4 Hydrogen carbonate HCO3 <==> H + CO3 4.8 x 10 10.32 3.68 2.10 x 10 -1 +1 2- -11 -3 Hydrogen telluride H4TeO6 <==> H + H3TeO6 1.0 x 10 11.00 3.00 1.0 x 10 +1 -1 -12 -3 Hydrogen peroxide H2O2 <===> H + HO2 2.4 x 10 11.62 2.38 4.17 x 10 -1 +1 2- -12 -3 Hydrogen silicate HSiO3 <==> H + SiO3 1.3 x 10 11.89 2.11 7.76 x 10 -2 +1 3- -13 -2 Hydrogen phosphate HPO4 <==> H + PO4 4.4 x 10 12.36 1.64 2.29 x 10 Hydrogen sulphide HS-1 <=====> H+1 + S2- 1.2 x 10-13 12.92 1.08 8.3 x 10-2 +1 -1 -14 Water H2O <=====> H + OH 1.0 x 10 14.00 0.00 1.0

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Page 1/7 Safety Data Sheet acc. to US OSHA GHS Printing date 11/09/2017 Reviewed on 11/09/2017

* 1 Identification . Product identifier . Trade name: Dipotassium Phosphate Article number: BK2771D . Article number: BK2771D . CAS Number: 7758-11-4 . Application of the substance / the mixture Fertilizer Formulation additive Food additives . Uses advised against Uses other than those recommended. . Manufacturer/Supplier: ICL 622 Emerson Road - Suite 500 St. Louis, Missouri 63141, USA . Information department: General information: +1 800 244 6169 (Worldwide) . Emergency telephone number: In USA call CHEMTREC: (800) 424 9300 Outside the USA, including ships at sea, call CHEMTREC’s international and maritime telephone number (collect calls accepted): +1 (703) 527-3887 In Canada call CANUTEC: 1 613 996 6666

* 2 Hazard(s) identification . Classification of the substance or mixture The substance is not classified according to the Globally Harmonized System (GHS). . GHS label elements Void . Hazard pictograms Void . Signal word Void . Hazard statements Void . Information pertaining to particular dangers for man and environment: Aqueous solutions or powders that become wet produce extremely slippery conditions.

3 Composition/information on ingredients . Chemical characterization: Substances . CAS No. Description 7758-11-4 dipotassium hydrogenorthophosphate . Description: crystalline powder

* 4 First-aid measures . Description of first aid measures . General information: Immediately remove any clothing soiled by the product. . After inhalation: Supply fresh air; consult doctor in case of complaints. . After skin contact: Wash with water and acidic soap. If symptoms persist consult doctor. . After eye contact: Rinse opened eye for 15 minutes under running water. If symptoms persist, consult a doctor. . After swallowing: Rinse out mouth and then drink plenty of water. If symptoms persist consult doctor. (Contd. on page 2) USA

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Trade name: Dipotassium Phosphate Article number: BK2771D

(Contd. of page 1) . Most important symptoms and effects, both acute and delayed No further relevant information available. . Indication of any immediate medical attention and special treatment needed No further relevant information available.

* 5 Fire-fighting measures . Extinguishing media . Suitable extinguishing agents: Use fire fighting measures that suit the environment. CO2, extinguishing powder or water spray. Fight larger fires with water spray or alcohol resistant foam. . For safety reasons unsuitable extinguishing agents: Water with full jet . Special hazards arising from the substance or mixture In case of fire, the following can be released: Phosphorus oxides (PxOy) . Advice for firefighters . Protective equipment: Do not inhale explosion gases or combustion gases. Wear self-contained respiratory protective device. . Additional information Aqueous solutions or powders that become wet produce extremely slippery conditions. Collect contaminated fire fighting water separately. It must not enter the sewage system. Dispose of fire debris and contaminated fire fighting water in accordance with official regulations.

* 6 Accidental release measures . Personal precautions, protective equipment and emergency procedures Avoid formation of dust. Ensure adequate ventilation Wear protective clothing. . Environmental precautions: Do not allow to enter sewers/ surface or ground water. . Methods and material for containment and cleaning up: Pick up mechanically. Avoid formation of dust. Aqueous solutions or powders that become wet produce extremely slippery conditions. . Reference to other sections See Section 7 for information on safe handling. See Section 8 for information on personal protection equipment. See Section 13 for disposal information. . Protective Action Criteria for Chemicals . PAC-1: 13 mg/m3 . PAC-2: 140 mg/m3 . PAC-3: 830 mg/m3

* 7 Handling and storage

. Handling: . Precautions for safe handling Prevent formation of dust. Ensure good ventilation/exhaustion at the workplace. (Contd. on page 3) USA

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Trade name: Dipotassium Phosphate Article number: BK2771D

(Contd. of page 2) The usual precautionary measures should be adhered to in handling the chemicals. Aqueous solutions or powders that become wet produce extremely slippery conditions. . Information about protection against explosions and fires: The product is not flammable. . Conditions for safe storage, including any incompatibilities . Storage: . Further information about storage conditions: Store in cool, dry conditions in well sealed receptacles. This product is hygroscopic. . Specific end use(s) No further relevant information available.

* 8 Exposure controls/personal protection . Additional information about design of technical systems: No further data; see item 7. . Control parameters . Components with limit values that require monitoring at the workplace: OSHA and ACGIH have not established specific exposure limits for this material. However, OSHA and ACGIH have established limits for particulates not otherwise regulated (PNOR) and particulates not otherwise classified (PNOC) which are the least stringent exposure limits applicable to dusts. OSHA PEL: 15 mg/m³ (total dust) 8-hr TWA, 5 mg/m³ (respirable) 8-hr TWA ACGIH TLV: 10 mg/m³ (inhalable) 8-hr TWA, 3 mg/m³ (respirable) 8-hr TWA . Additional information: The lists that were valid during the creation were used as basis. . Exposure controls . Appropriate engineering controls Provide natural or mechanical ventilation to control exposure levels below occupational exposure limits. The use of local mechanical exhaust ventilation is preferred at sources of air contamination such as open process equipment. Consult National Fire Protection Association (NFPA) Standard 91 for design of exhaust systems. . Personal protective equipment: . General protective and hygienic measures: The usual precautionary measures for handling chemicals should be followed. Wash hands before breaks and at the end of work. Avoid contact with the eyes and skin. . Respiratory Protection: Dust mask according to DIN EN 140 or 149 (FFP1 or FFP2) . Protection of hands: Protective gloves . Material of gloves Butyl rubber, BR Fluorocarbon rubber (Viton) Nitrile rubber, NBR Natural rubber, NR Chloroprene rubber, CR Neoprene gloves . Penetration time of glove material The exact break through time has to be found out by the manufacturer of the protective gloves and has to be observed. . Eye protection: Safety glasses

9 Physical and chemical properties . Information on basic physical and chemical properties . General Information . Appearance: Form: Crystalline powder Color: White (Contd. on page 4) USA

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Trade name: Dipotassium Phosphate Article number: BK2771D

(Contd. of page 3) . Odor: Odorless . Odor threshold: Not applicable . pH-value (10 g/l) at 20 °C (68 °F): ca. 9.2 . Change in condition Melting point/Melting range: ca. 253 °C (ca. 487 °F) Boiling point/Boiling range: Not determined . Flash point: Not applicable. . Flammability (solid, gaseous): Product is not flammable. . Auto-ignition temperature: Not applicable . Decomposition temperature: Not determined . Danger of explosion: Product does not present an explosion hazard. . Explosion limits: Lower: Not applicable Upper: Not applicable . Oxidizing properties None . Vapor pressure: Not applicable . Density: Bulk density at 20 °C (68 °F): ca. 1080 kg/m3 Evaporation rate Not applicable . Solubility in / Miscibility with Water at 20 °C (68 °F): ca. 1600 g/l . Partition coefficient (n-octanol/water): ca. -2 log POW . Viscosity: Dynamic: Not applicable Kinematic: Not applicable . Other information No further relevant information available.

* 10 Stability and reactivity . Reactivity No hazardous reactions when stored and handled according to instructions. . Chemical stability . Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications. . Possibility of hazardous reactions No further relevant information available. . Conditions to avoid Exposure to moisture. . Incompatible materials: May react vigorously with strong acids. . Hazardous decomposition products: In case of fire, the following can be released: Phosphorus oxides (PxOy) . Additional information: This product is hygroscopic. (Contd. on page 5) USA

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Trade name: Dipotassium Phosphate Article number: BK2771D

(Contd. of page 4)

11 Toxicological information . Information on toxicological effects . Acute toxicity: . LD/LC50 values that are relevant for classification : 7758-11-4 dipotassium hydrogenorthophosphate Oral LD50 > 2000 mg/kg (rat) (OECD 420) Dermal LD50 > 5000 mg/kg (rabbit) (OECD 402) Inhalative LC50 (4 h) >0.83 mg/L (rat) (OECD 403 READ ACROSS) . Primary irritant effect: . on the skin: Based on available data, the classification criteria are not met. . on the eye: Based on available data, the classification criteria are not met. . Sensitization: No sensitizing effects known. . Additional toxicological information: When used and handled according to specifications, the product does not have any harmful effects according to our experience and the information provided to us. The substance is not subject to classification. 7758-11-4 dipotassium hydrogenorthophosphate Oral NOAEL, systemische Effekte >1000 mg/kg bw/day (rat) (OECD 422) . Carcinogenic categories . IARC (International Agency for Research on Cancer) Substance is not listed. . NTP (National Toxicology Program) Substance is not listed. . OSHA-Ca (Occupational Safety & Health Administratio n) Substance is not listed.

12 Ecological information . Toxicity . Aquatic toxicity: 7758-11-4 dipotassium hydrogenorthophosphate LC50 (96 h) >100 mg/L (rainbow trout) (OECD 203 READ ACROSS) EC50 (3 h) >1000 mg/L (activated sludge) (OECD 209) EC50 (48 h) >100 mg/L (daphnia magna) (OECD 202 READ ACROSS) EC50 (72 h) >100 mg/L (desmodesmus subspicatus) (OECD 201 READ ACROSS) . Persistence and degradability Inorganic salts are basicly not biodegradable. . Other information: Easy elimination possible by flocculation or adsorption by sludge. . Behavior in environmental systems: . Components: Product should not get in higher quantities into waste water because it may act as a plant nutrient and precipitate heavy metals. . Bioaccumulative potential Does not accumulate in organisms . Mobility in soil No further relevant information available. . Ecotoxical effects: . Other information: No COD, no BOD, no AOX No VOC according to EC-directive 1999/13/EC (Contd. on page 6) USA

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Trade name: Dipotassium Phosphate Article number: BK2771D

(Contd. of page 5) . Additional ecological information: . General notes: Do not allow undiluted product or large quantities of it to reach ground water, water course or sewage system. . Other adverse effects No further relevant information available.

13 Disposal considerations . Waste treatment methods . Recommendation: Smaller quantities can be disposed of with household waste. Can be disposed of with household garbage after consulting with the waste disposal facility operator and the pertinent authorities and adhering to the necessary technical regulations. . Uncleaned packagings: . Recommendation: Dispose of packaging according to regulations on the disposal of packagings. Empty contaminated packagings thoroughly. They can be recycled after thorough and proper cleaning. Packagings that cannot be cleansed are to be disposed of in the same manner as the product. . Recommended cleansing agent: Water, if necessary with cleansing agents.

14 Transport information . UN-Number . DOT, ADN, IMDG, IATA Void . UN proper shipping name . DOT, ADR/RID/ADN, ADN, IMDG, IATA Void . Transport hazard class(es) . DOT, ADR/RID/ADN, ADN, IMDG, IATA . Class Void . Packing group . DOT, ADR/RID/ADN, IMDG, IATA Void . Environmental hazards: Not applicable. . Special precautions for user Not applicable. . Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not applicable. . Transport/Additional information: Not dangerous according to the above specifications. . UN "Model Regulation": Void

* 15 Regulatory information . Safety, health and environmental regulations/legislation specific for the substance or mixture . TSCA (Toxic Substances Control Act): Substance is listed. . National regulations: Void . Other regulations, limitations and prohibitive regulations . Chemical inventories: Europe (EINECS): yes Australia (AICS): yes Canada (DSL): yes Japan (ENCS): yes China (IECSC): yes Korea (KECI): yes USA (TSCA): yes (Contd. on page 7) USA

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Trade name: Dipotassium Phosphate Article number: BK2771D

(Contd. of page 6) Philippines (PICCS): yes New Zealand (NZIOCL): yes

* 16 Other information This information is based on our present knowledge. However, this shall not constitute a guarantee for any specific product features and shall not establish a legally valid contractual relationship. . Department issuing SDS: Product Safety . Contact: [email protected] . Date of preparation / last revision 11/09/2017 / 3 . Abbreviations and acronyms: ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the International Carriage of Dangerous Goods by Road) IMDG: International Maritime Code for Dangerous Goods DOT: US Department of Transportation IATA: International Air Transport Association CAS: Chemical Abstracts Service (division of the American Chemical Society) LC50: Lethal concentration, 50 percent LD50: Lethal dose, 50 percent OSHA: Occupational Safety & Health TLV: Threshold Limit Value PEL: Permissible Exposure Limit REL: Recommended Exposure Limit . Sources source ECHA: European Chemicals Agency, http://echa.europa.eu/ . * Data compared to the previous version altered. USA

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* 1 Identification

· Product identifier · Trade name: MKP · Article number: 9744080200, 9744080100 · CAS Number: 7778-77-0 · EC number: 231-913-4 · Index number: None · Application of the substance / the mixture Fertilizer Detergents Water treatment Food additive Feed additive Fire retarding agent Processing aid/ Additive · Details of the supplier of the safety data sheet · Manufacturer/Supplier: Manufacturer: Rotem Amfert Negev Ltd. ICl Specialty Fertilizers Shalit House Shezar 3 St. P.O.Box 125 Beer-Sheva, 84101 ISRAEL Tel: + 972-8-6598877 Fax: + 972-8-6598987

Supplier: ICL Premium Fertilizers NA 622 Emerson Rd Suite 500 St. Louis, MO 63141, USA Tel: 1-877-ROTEM-US Fax: (314)983-7611 [email protected] · Emergency telephone number: CHEMTREC : 1-800-424-9300

* 2 Hazard(s) identification

· Classification of the substance or mixture The substance is not classified according to the Globally Harmonized System (GHS). · GHS label elements Void · Hazard pictograms Void · Signal word Void · Hazard statements Void (Contd. on page 2) US

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Trade name: MKP

(Contd. of page 1) · Classification system: · NFPA ratings (scale 0 - 4) Health = 0 0 Fire = 0 0 0 Reactivity = 0 · HMIS-ratings (scale 0 - 4) HEALTH 1 Health = 1 FIRE 0 Fire = 0 REACTIVITY 0 Reactivity = 0 · Other hazards None

3 Composition/information on ingredients

· Chemical characterization: Substances · CAS No. Description 7778-77-0 potassium dihydrogenorthophosphate · Identification number(s) · EC number: 231-913-4

4 First-aid measures

· General information: No special measures required. · After inhalation: Supply fresh air; consult doctor in case of complaints. · After skin contact: Generally the product does not irritate the skin. Rinse with warm water. If skin irritation continues, consult a doctor. · After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult a doctor. · After swallowing: Rinse out mouth and then drink plenty of water. If symptoms persist consult doctor. NOTE: Never give an unconscious person anything to drink. · Information for doctor: · Most important symptoms and effects, both acute and delayed No further relevant information available. · Indication of any immediate medical attention and special treatment needed No further relevant information available.

5 Fire-fighting measures

· Suitable extinguishing agents: The product is not flammable. Use fire fighting measures that suit the environment. · For safety reasons unsuitable extinguishing agents: None · Special hazards arising from the substance or mixture In case of fire, the following can be released: Phosphorus oxides (e.g. P2O5) · Protective equipment: Wear fully protective suit. (Contd. on page 3) US

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Trade name: MKP

(Contd. of page 2) Mouth respiratory protective device. · Additional information Collect contaminated fire fighting water separately. It must not enter the sewage system.

6 Accidental release measures

· Personal precautions, protective equipment and emergency procedures Avoid formation of dust. Use respiratory protective device against the effects of fumes/dust/aerosol. Wear protective clothing. · Environmental precautions: Do not allow to enter sewers/ surface or ground water. · Methods and material for containment and cleaning up: Pick up mechanically. · Reference to other sections See Section 13 for disposal information.

7 Handling and storage

· Handling: · Precautions for safe handling Ensure good ventilation/exhaustion at the workplace. Prevent formation of dust. · Information about protection against explosions and fires: The product is not flammable. No special measures required. · Requirements to be met by storerooms and receptacles: Store in dry conditions. Protect from heat and direct sunlight. · Information about storage in one common storage facility: Store away from oxidizing agents. Do not store together with alkalis (caustic solutions). · Further information about storage conditions: Protect from humidity and water. Store in a cool place. · Specific end use(s) No further relevant information available.

* 8 Exposure controls/personal protection

· Components with limit values that require monitoring at the workplace: Not required. · Additional information: Ventilation must be sufficient to maintain TLV-TWA below 3 mg/m³, respirable particles, and 10 mg/m³, inhalable particles [ACGIH recommendation for Particles (Insoluble or poorly soluble). Not Otherwise Specified (PNOS)] · Personal protective equipment: · General protective and hygienic measures: The usual precautionary measures for handling chemicals should be followed. Keep away from foodstuffs, beverages and feed. Immediately remove all soiled and contaminated clothing. Wash hands before breaks and at the end of work. Do not eat or drink while working. (Contd. on page 4) US

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Trade name: MKP

(Contd. of page 3) · Breathing equipment: Use suitable respiratory protective device in case of insufficient ventilation.

Filter P2

· Protection of hands:

Protective gloves

· Material of gloves The selection of the suitable gloves does not only depend on the material, but also on further marks of quality and varies from manufacturer to manufacturer. · Penetration time of glove material The exact break trough time has to be found out by the manufacturer of the protective gloves and has to be observed. · Eye protection:

Safety glasses

· Body protection: Protective work clothing · Limitation and supervision of exposure into the environment Based on all data available this product is not considered to pose a risk to the environment.

* 9 Physical and chemical properties

· Appearance: Form: Crystalline Color: White · Odor: Odorless · pH-value (208 g/l) at 20 °C (68 °F): 4.2-4.5 · Change in condition Melting point/Melting range: 252.6 °C (487 °F) Boiling point/Boiling range: >450 °C (>842 °F) · Flash point: Not applicable. This product is inorganic substance. · Flammability (solid, gaseous): Product is not flammable. (based on molecular structure) · Ignition temperature: Not applicable · Decomposition temperature: >450 °C (>842 °F) Thermal decomposition on losing water. · Auto igniting: Product is not selfigniting. (based on molecular structure) · Danger of explosion: Product does not present an explosion hazard. (based on molecular structure) (Contd. on page 5) US

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Trade name: MKP

(Contd. of page 4) · Explosion limits: None · Oxidizing properties None The substance does not contain any groups associated with oxidising properties. · Vapor pressure at 25 °C (77 °F): 4.5x10-15 Pa · Density at 20 °C (68 °F): 2.34 g/cm³ (19.527 lbs/gal) · Bulk density at 20 °C (68 °F): 1150-1200 kg/m³ · Solubility in / Miscibility with Water at 20 °C (68 °F): 208 g/l · Partition coefficient (n-octanol/water): Not applicable This substance is inorganic chemical. · Viscosity: Not applicable This product is solid. Viscosity is only relevant to liquids. · Other information No further relevant information available.

* 10 Stability and reactivity

· Reactivity Reacts with alkali (lyes). · Chemical stability No decomposition if used and stored according to specifications. · Possibility of hazardous reactions Reacts with oxidizing agents. · Conditions to avoid Water To avoid thermal decomposition do not overheat. · Incompatible materials: Alkalis Oxidizing agents · Hazardous decomposition products: Formation of toxic gases is possible during heating or in case of fire. Phosphorus oxides (e.g. P2O5) · Additional information: This product is hygroscopic.

* 11 Toxicological information

· Information on toxicological effects · Acute toxicity: · LD/LC50 values that are relevant for classification: no classification is necessary 14887-42-4 Potassium pentahydrogen bis(phosphate) Dermal LD50 >2000 mg/kg (rabbit) (OECD 402) 7558-80-7 sodium dihydrogenorthophosphate Inhalative LC50/4 h >0.83 mg/l (rat) (OECD 403) the maximum attainable concentration 7778-77-0 potassium dihydrogenorthophosphate Oral LD50 >2000 mg/kg (rat) (Contd. on page 6) US

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Trade name: MKP

(Contd. of page 5) · Primary irritant effect: · Effect Species Method 7558-80-7 sodium dihydrogenorthophosphate Sensitization OECD 429, EC B.42 none (mouse) 7778-77-0 potassium dihydrogenorthophosphate Irritation of skin OECD 404 not irritating (rabbit) Irritation of eyes OECD 405, EC B.5 not irritating (rabbit) · Toxicokinetics, metabolism and distribution This product dissociates into potassium and phosphate ions, which are normal body and nutritional components. This substance is not considered to have bioaccumulative potential as it is highly soluble in water and phosphate levels in the body are regulated via homeostasis. · CMR effects (carcinogenity, mutagenicity and toxicity for reproduction) · Mutagenicity: Sodium and potassium phosphates are routinely used in the nutrient broths that support bacterial colonies in the laboratory and as such bacteria are constantly exposed to these inorganic phosphates. The constant exposure of bacteria to these materials suggests that they pose no inherent risk of genotoxicity. None · Carcinogenity: no data available (no carcinogenicity study needs to be performed as this substance is not genotoxic) · Toxicity for reproduction: no classification is necessary 7758-11-4 dipotassium hydrogenorthophosphate, OECD 422 : developmental toxicity: NOAEL> 1000 mg/kg bw/day; rat, oral 7778-77-0 potassium dihydrogenorthophosphate: developmental / maternal toxicity: NOAEL> 282 mg/kg bw/day; rat, oral developmental / maternal toxicity: NOAEL> 320 mg/kg bw/day; mouse, oral

* 12 Ecological information

· Toxicity · Aquatic toxicity: Inorganic phosphates are not considered to be toxic to aquatic species. No reliable study with this product is present. This study is conducted on an analogous substance. (read-across) 6922-99-4 Tripotassium trihydrogen diphosphate dihydrate EC50/48 h (static) >100 mg/L (Daphnia magna) (OECD 202, freshwater) EC50/72 h (static) >100 mg/L (algae) (OECD 201, freshwater) LC50/96 h >100 mg/L (fish Oncorhynchus mykiss) (OECD 203, freshwater, semi-static) · Persistence and degradability The substance is inorganic; therefore no biodegradation tests are applicable. This product dissociates into potassium and phosphate ions, which cannot be further degraded. · Bioaccumulative potential Does not accumulate in organisms This substance is highly water soluble and dissociating. This product dissociates into potassium and phosphate ions, which are ubiquitous in the environment. · Mobility in soil This substance is highly water soluble and dissociating. Low potential for adsorption (based on substance properties). (Contd. on page 7) US

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Trade name: MKP

(Contd. of page 6) · Other information: Product should not get in high quantities into waste water because it may act as a plant nutrient and cause eutrophication. · Behavior in sewage processing plants: · Type of test Effective concentration Method Assessment 7758-11-4 dipotassium hydrogenorthophosphate EC50/3 h >1000 mg/L (activated sludge) (OECD 209) NOEC (3 h): 1000 mg/L · Remark: No reliable study with this product is present. This study is conducted on an analogous substance. (read-across) Inorganic phosphates are not considered to be toxic to sewage treatment plant microorganisms. · General notes: Generally not hazardous for water Do not allow undiluted product or large quantities of it to reach ground water, water course or sewage system. · Results of PBT and vPvB assessment · PBT: No assessment is required for inorganic substances. · vPvB: No assessment is required for inorganic substances. · Other adverse effects No further relevant information available.

* 13 Disposal considerations

· Waste treatment methods · Recommendation: This product is used as fertiliser. However, large spills can kill vegetation. Prevent large quantities from entering waterways. If uncontaminated, sweep up or collect, and reuse as product. If contaminated with other materials, collect in suitable containers. Can be reused without reprocessing. Can be disposed of with household garbage after consulting with the waste disposal facility operator and the pertinent authorities and adhering to the necessary technical regulations. Disposal must be made in accordance with Local Authority requirements. · Uncleaned packagings: · Recommendation: Packaging can be reused or recycled after cleaning. Disposal must be made in accordance with Local Authority requirements. · Recommended cleansing agent: Water, if necessary with cleansing agents.

* 14 Transport information

· UN-Number None · UN proper shipping name None · Transport hazard class(es) · DOT, ADR, ADN, IMDG, IATA · Class Void · Packing group None · Environmental hazards: · Marine pollutant: No · Special precautions for user Not applicable. (Contd. on page 8) US

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Trade name: MKP

(Contd. of page 7) · Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code None · Transport/Additional information: Not dangerous according to the above specifications. · UN "Model Regulation": Void

* 15 Regulatory information

· Sara · Section 355 (extremely hazardous substances): Substance is not listed. · Section 313 (Specific toxic chemical listings): Substance is not listed. · TSCA (Toxic Substances Control Act): Substance is listed. · Proposition 65 · Chemicals known to cause cancer: Substance is not listed. · Chemicals known to cause reproductive toxicity for females: Substance is not listed. · Chemicals known to cause reproductive toxicity for males: Substance is not listed. · Chemicals known to cause developmental toxicity: Substance is not listed. · Cancerogenity categories · EPA (Environmental Protection Agency) Substance is not listed. · IARC (International Agency for Research on Cancer) Substance is not listed. · NTP (National Toxicology Program) Substance is not listed. · TLV (Threshold Limit Value established by ACGIH) Substance is not listed. · NIOSH-Ca (National Institute for Occupational Safety and Health) Substance is not listed. · Canadian substance listings: · Canadian Domestic Substances List (DSL) Substance is listed. · GHS label elements Void · Hazard pictograms Void · Signal word Void · Hazard statements Void · National regulations: · Additional classification according to Decree on Hazardous Materials: None · Registration status (Chemical Inventories listing) : Europe (EINECS) : listed REACH Registration number: 01-2119490224-41-0015 Australia (AICS) : listed Japan (ENCS) : listed Korea (KECI) : listed Philippines (PICCS) : listed China (IECSC) : listed NTP (National Toxicology Program) : Substance is not listed IARC (International Agency for Research on Cancer) : Substance is not listed

* 16 Other information

· Department issuing SDS: Regulatory Affairs of ICL Fertilizers Products · Date of preparation / last revision 12/18/2016 / 5 · * Data compared to the previous version altered. Reason for revision: company logo change The sections where alterations took place are marked with an asterisk in the left border. (Contd. on page 9) US

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Trade name: MKP

(Contd. of page 8) · Disclaimer Although the information and recommendations set forth herein (hereinafter ""information"") are presented in good faith and believed to be correct as of the date hereof, Rotem Amfert Negev Ltd. makes no representations as to the completeness or accuracy thereof. Information is supplied upon the condition that the persons receiving same will make their own determination as to its safety and suitability for their purposes prior to use. In no event will Rotem Amfert Negev Ltd. be responsible for damages of any nature whatsoever resulting from the use of or reliance upon information. NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESSED OR IMPLIED, OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR OF ANY OTHER NATURE, ARE MADE HEREUNDER WITH RESPECT TO INFORMATION OR THE PRODUCT TO WHICH THE INFORMATION REFERS. US

43.3.0 Chemical Report Generated: Sunday, January 27, 2019 1:59:53 AM, GMT-8

CAS Numbers 7758-11-4

Western Europe Main Term (EU) EC Number: 231-834-5 Registration status under REACH Article 10 as a full dossier: Yes Dossier published on the Dissemination Portal: Yes

Notes

Yes Indicates the substance is officially registered under REACH.

EU. Inventory of Cosmetic Ingredients and Fragrances (Decision 96/335/EC establishing INCI List; and CosIng Ingredients/Fragrances Inventory (version 2)), last updated 8 May 2015

CAS RN: 7758-11-4 may be regulated as a member of the Generics group for CAS RN: 16068- 46-5 Generics group name: POTASSIUM PHOSPHATE COSING Ref. No.: 79722 EC Number: 240-213-8 Application Name: Buffering INCI Name: * Upload Date: 15/10/2010

CAS RN: 7758-11-4 may be regulated as a member of the Generics group for CAS RN: 16068- 46-5 Generics group name: KALII DIHYDROGENOPHOSPHAS COSING Ref. No.: 79722 EC Number: 240-213-8 Application Name: Buffering Ph. Eur. Name: * Upload Date: 15/10/2010

CAS RN: 7758-11-4 may be regulated as a member of the Generics group for CAS RN: 16068- 46-5 Generics group name: POTASSIUM DIHYDROGENORTHOPHOSPHATE COSING Ref. No.: 79722 EC Number: 240-213-8 Application Name: Buffering Chem/IUPAC Name: * Upload Date: 15/10/2010

CAS RN: 7758-11-4 may be regulated as a member of the Generics group for CAS RN: 16068- 46-5 Generics group name: POTASSIUM PHOSPHATE, MONOBASIC COSING Ref. No.: 79722 EC Number: 240-213-8 Application Name: Buffering

INN Name: * Upload Date: 10/15/2010

CAS RN: 7758-11-4

Name: DIPOTASSIUM PHOSPHATE COSING Ref. No.: 75739 EC Number: 231-834-5 Application Name: Anticorrosive, Buffering INCI Name: * Upload Date: 15/10/2010

CAS RN: 7758-11-4

Name: DIPOTASSIUM HYDROGENORTHOPHOSPHATE COSING Ref. No.: 75739 EC Number: 231-834-5 Application Name: Anticorrosive, Buffering Chem/IUPAC Name: * Upload Date: 15/10/2010

EC Number: 231-834-5 WGK Identification Number: 8172 The WGK class is: 1 (slightly water-endangering)

Switzerland

Switzerland. Toxins List 1 (Giftliste 1), Parts A & B, 2003/2004 Edition, as amended by BBl, n. 19, p. 3065, 17 May 2005 (Revoked; for historical reference only)

CAS RN: 7758-11-4

Name: DIKALIUM-HYDROGENPHOSPHAT Toxicity Category: 5 Swiss Identification Number: G-7424 Note(s): c5

CAS RN: 7758-11-4

Name: KALIUM-HYDROGENPHOSPHAT Toxicity Category: 5 Swiss Identification Number: G-7424 Note(s): c5

CAS RN: 7758-11-4

Name: SEK.-KALIUMPHOSPHAT Toxicity Category: 5 Swiss Identification Number: G-7424 Note(s): c5

Notes

c5 Toxicity Category 5 is determined by acute oral lethal doses of 2000 - 5000 mg/kg in small animals; however, other factors may be taken into consideration regarding data in other types of animals or other affects whether subacute, subchronic or chronic.

International International

OSPAR PLONOR List. Substances/preparations used and discharged offshore which are considered to pose little or no risk to the environment (2016)

CAS RN: 7758-11-4 may be regulated as a member of the Generics group for CAS RN: 16068- 46-5 Generics group name: POTASSIUM PHOSPHATE

CAS RN: 7758-11-4

Name: POTASSIUM PHOSPHATE DIBASIC (K2HPO4 OR H3O4P.2K)

North America Main Term (NA)

Main Term (North America)

U.S. Federal, TSCA

TSCA IUR 2006, Partially Exempt Inorganic Chemical Substances (40 CFR 710.46(b)(3))

CAS RN: 7758-11-4 may be regulated as a member of the Generics group for CAS RN: SEQ103526 Generics group name: INORGANIC CHEMICAL SUBSTANCES (AS DEFINED BY 40 CFR 710.46(B)(3)) Note(s): iui1

Notes iui1 40 CFR 710.46(b)(3) Inorganic chemical substances. For purposes of this subpart, an inorganic chemical substance is any chemical substance which does not contain carbon or contains carbon only in the form of carbonato [=CO3], cyano [--CN], cyanato [--OCN], isocyano [--NC], or isocyanato [--NCO] groups or the chalcogen analogues of such groups.

TSCA Interim List of Active Substances (40 CFR 711, as updated through February 2018)

CAS RN: 7758-11-4 may be regulated as a member of the Generics group for CAS RN: 16068- 46-5 Generics group name: Phosphoric acid, potassium salt (1:?)

CAS RN: 7758-11-4

Name: Phosphoric acid, potassium salt (1:2)

TSCA. 2012 Chemical Data Reporting (CDR) Results (13 August 2012)

CAS RN: 7758-11-4

Name: Phosphoric acid, potassium salt (1:2) Activity: B, I, M

Notes

B Both Manufactured and Imported

I Imported

M Manufactured

TSCA Exemption List of Active Substances (as updated through February 2018)

CAS RN: 7758-11-4 may be regulated as a member of the Generics group for CAS RN: 16068- 46-5 Generics group name: Phosphoric acid, potassium salt (1:?) Designation: ACTIVE

CAS RN: 7758-11-4

Name: Phosphoric acid, potassium salt (1:2) Designation: ACTIVE

U.S. Federal, Food and Drugs

USA. Substances Generally Recognized as Safe (GRAS). FDA (21 CFR 182) (April 1, 2008)

CAS RN: 7758-11-4

Name: Dipotassium phosphate Application: Any food Functional Class: Sequestrant Maximum: GMP

CFR Section: CFR Section 182.6285

USA. Substances Added to Food (formerly EAFUS, as amended through 26 June 2018)

CAS RN: 7758-11-4

Name: DIPOTASSIUM PHOSPHATE Technical Effect(s): NUTRIENT SUPPLEMENT; PH CONTROL AGENT; SEQUESTRANT; STABILIZER OR THICKENER; EMULSIFIER OR EMULSIFIER SALT Synonyms: DIPOTASSIUM HYDROGEN PHOSPHATE; DIPOTASSIUM MONOPHOSPHATE; DIPOTASSIUM ORTHOPHOSPHATE; DIPOTASSIUM PHOSPHATE; PHOSPHORIC ACID, DIPOTASSIUM SALT; POTASSIUM MONOHYDROGEN PHOSPHATE; POTASSIUM MONOPHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC CFR Food Additive Sections: 175.105; 182.6285 CFR Food Labeling Sections: 133.169; 133.173; 133.179

FDA. Inactive Ingredients for Approved Drug Products (updated through 15 November 2016)

CAS RN: 7758-11-4

Name: POTASSIUM CARBONATE Route: INTRA-ARTICULAR Dosage Form: INJECTION UNII: CI71S98N1Z Maximum Potency Amount: 0.6 Potency Unit: %

CAS RN: 7758-11-4

Name: POTASSIUM CARBONATE Route: INTRAMUSCULAR Dosage Form: INJECTION UNII: CI71S98N1Z Maximum Potency Amount: 0.6 Potency Unit: %W/V

CAS RN: 7758-11-4

Name: POTASSIUM CARBONATE Route: INTRAVENOUS Dosage Form: SOLUTION UNII: CI71S98N1Z

CAS RN: 7758-11-4

Name: POTASSIUM CARBONATE Route: IV(INFUSION) Dosage Form: INJECTION UNII: CI71S98N1Z Maximum Potency Amount: 55.2 Potency Unit: %

CAS RN: 7758-11-4

Name: POTASSIUM CARBONATE Route: ORAL Dosage Form: CAPSULE

UNII: CI71S98N1Z Maximum Potency Amount: 30 Potency Unit: MG

CAS RN: 7758-11-4

Name: POTASSIUM CARBONATE Route: ORAL Dosage Form: POWDER, FOR SUSPENSION UNII: CI71S98N1Z Maximum Potency Amount: 50 Potency Unit: MG/1SCP

CAS RN: 7758-11-4

Name: POTASSIUM CARBONATE Route: ORAL Dosage Form: SOLUTION UNII: CI71S98N1Z Maximum Potency Amount: 69 Potency Unit: MG/5ML

CAS RN: 7758-11-4

Name: POTASSIUM CARBONATE Route: ORAL Dosage Form: SUSPENSION UNII: CI71S98N1Z Maximum Potency Amount: 5 Potency Unit: MG/1ML

CAS RN: 7758-11-4

Name: POTASSIUM CARBONATE Route: ORAL Dosage Form: SYRUP UNII: CI71S98N1Z Maximum Potency Amount: 22 Potency Unit: MG/5ML

CAS RN: 7758-11-4

Name: POTASSIUM CARBONATE Route: ORAL Dosage Form: TABLET UNII: CI71S98N1Z

CAS RN: 7758-11-4

Name: POTASSIUM CARBONATE Route: SUBCUTANEOUS Dosage Form: INJECTION UNII: CI71S98N1Z Maximum Potency Amount: 1.36 Potency Unit: %

CAS RN: 7758-11-4

Name: POTASSIUM CARBONATE

Route: SUBCUTANEOUS Dosage Form: POWDER, FOR INJECTION SOLUTION, LYOPHILIZED UNII: CI71S98N1Z Maximum Potency Amount: 0.19 Potency Unit: %

U.S. Federal, Pesticides

Pesticide Chemical Tolerance Exemptions, Inert Ingredients Used Pre-Harvest (40 CFR 180.920; as amended through 1 August 2018)

CAS RN: 7758-11-4 may be regulated as a member of the Generics group for CAS RN: 16068- 46-5 Generics group name: Dipotassium hydrogen phosphate Uses: Buffering agent

Pesticide Chemical Tolerance Exemptions, Inert Ingredients Used Pre- and Post-Harvest (40 CFR 180.910; as amended through 24 August 2018)

CAS RN: 7758-11-4 may be regulated as a member of the Generics group for CAS RN: 16068- 46-5 Generics group name: Potassium phosphate Group: Potassium phosphate Use: Buffer

EPA Pesticide Active Ingredients with Registration Status: Conventional Chemicals, Antimicrobial, and Biopesticides (2017)

CAS RN: 7758-11-4

Name: Dipotassium phosphate Registration Status: Registered Pesticide Type: Biopesticides,Conventional Chemical

Inert Ingredients Permitted for Use in Nonfood Use Pesticide Products (April 2011)

CAS RN: 7758-11-4 may be regulated as a member of the Generics group for CAS RN: 16068- 46-5 Generics group name: POTASSIUM PHOSPHATE

CAS RN: 7758-11-4

Name: PHOSPHORIC ACID, DIPOTASSIUM SALT

U.S. Federal, Right-To-Know

DOE. Protective Action Criteria (PAC) Rev 29: Chemicals with AEGLs, ERPGs or TEELs (May 2016)

CAS RN: 7758-11-4

Name: Potassium phosphate, dibasic PAC-1 is: 13 mg/m3. PAC-2 is: 140 mg/m3. PAC-3 is: 830 mg/m3. Unit: mg/m3 mg/m3.

Canada

Canada. Categorization of Existing Substances on DSL (September 2006)

CAS RN: 7758-11-4 may be regulated as a member of the Generics group for CAS RN: 16068- 46-5 Generics group name: PHOSPHORIC ACID, POTASSIUM SALT Substance category: IOG Meets CEPA criteria: No Meets human health criteria: No Meets environmental criteria: No Persistent: Yes Bioaccumulative: No Inherently toxic to aquatic organisms: No

CAS RN: 7758-11-4

Name: PHOSPHORIC ACID, DIPOTASSIUM SALT Substance category: IOG Meets CEPA criteria: No Meets human health criteria: No Human health priority: Low Meets environmental criteria: No Persistent: Yes Bioaccumulative: No Inherently toxic to aquatic organisms: No

Notes

IOG Inorganics

Quebec. Guidance WHMIS Classifications (CSST/SRT) (September 29, 2014)

CAS RN: 7758-11-4

Name: POTASSIUM PHOSPHATE DIBASIC Classification: UP

Notes

UP Uncontrolled product

Quebec. Guidance WHMIS 2015 Classifications (CNESST) as amended through 14 December 2017

CAS RN: 7758-11-4

Name: Potassium phosphate dibasic (en-US) Additional languages >>

NAME Language

Phosphate de potassium dibasique French

Classification Codes: Uncontrolled product Classification: [Uncontrolled product]

Chemical Report Generated: Sunday, January 27, 2019 1:57:27 AM, GMT-8

CAS Numbers 7778-77-0

Western Europe Main Term (EU)

EU. Inventory of Cosmetic Ingredients and Fragrances (Decision 96/335/EC establishing INCI List; and CosIng Ingredients/Fragrances Inventory (version 2)), last updated 8 May 2015

CAS RN: 7778-77-0 may be regulated as a member of the Generics group for CAS RN: 16068- 46-5 Generics group name: POTASSIUM PHOSPHATE COSING Ref. No.: 79722 EC Number: 240-213-8 Application Name: Buffering INCI Name: * Upload Date: 15/10/2010

CAS RN: 7778-77-0 may be regulated as a member of the Generics group for CAS RN: 16068- 46-5 Generics group name: KALII DIHYDROGENOPHOSPHAS COSING Ref. No.: 79722 EC Number: 240-213-8 Application Name: Buffering Ph. Eur. Name: * Upload Date: 15/10/2010

CAS RN: 7778-77-0 may be regulated as a member of the Generics group for CAS RN: 16068- 46-5 Generics group name: POTASSIUM DIHYDROGENORTHOPHOSPHATE COSING Ref. No.: 79722 EC Number: 240-213-8 Application Name: Buffering Chem/IUPAC Name: * Upload Date: 15/10/2010

CAS RN: 7778-77-0 may be regulated as a member of the Generics group for CAS RN: 16068- 46-5 Generics group name: POTASSIUM PHOSPHATE, MONOBASIC COSING Ref. No.: 79722 EC Number: 240-213-8 Application Name: Buffering INN Name: * Upload Date: 10/15/2010

CAS RN: 7778-77-0

Name: POTASSIUM DIHYDROGENORTHOPHOSPHATE COSING Ref. No.: 79722

EC Number: 231-913-4 Application Name: Buffering Chem/IUPAC Name: * Upload Date: 15/10/2010

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC COSING Ref. No.: 79722 EC Number: 231-913-4 Application Name: Buffering INN Name: * Upload Date: 10/15/2010

CAS RN: 7778-77-0

Name: KALII DIHYDROGENOPHOSPHAS COSING Ref. No.: 79722 EC Number: 231-913-4 Application Name: Buffering Ph. Eur. Name: * Upload Date: 15/10/2010

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE COSING Ref. No.: 79722 EC Number: 231-913-4 Application Name: Buffering INCI Name: * Upload Date: 15/10/2010

Switzerland

Switzerland. Toxins List 1 (Giftliste 1), Parts A & B, 2003/2004 Edition, as amended by BBl, n. 19, p. 3065, 17 May 2005 (Revoked; for historical reference only)

CAS RN: 7778-77-0

Name: KALIUM-DIHYDROGENPHOSPHAT Toxicity Category: 5 Swiss Identification Number: G-7423 Note(s): c5

CAS RN: 7778-77-0

Name: PRIM.-KALIUMPHOSPHAT Toxicity Category: 5 Swiss Identification Number: G-7423 Note(s): c5

Notes

c5 Toxicity Category 5 is determined by acute oral lethal doses of 2000 - 5000 mg/kg in small animals; however, other factors may be taken into consideration regarding data in other types of animals or other affects whether subacute, subchronic or chronic.

International International

OSPAR PLONOR List. Substances/preparations used and discharged offshore which are considered to pose little or no risk to the environment (2016)

CAS RN: 7778-77-0 may be regulated as a member of the Generics group for CAS RN: 16068- 46-5 Generics group name: POTASSIUM PHOSPHATE

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE MONOBASIC (KH2PO4)

North America Main Term (NA)

Main Term (North America)

CAS RN: 7778-77-0 may be regulated as a member of the Generics group for CAS RN: 16068- 46-5 Generics group name: PHOSPHORIC ACID, POTASSIUM SALT

CAS RN: 7778-77-0

Name: PHOSPHORIC ACID, MONOPOTASSIUM SALT

CAS RN: 7778-77-0 may be regulated as a member of the Generics group for CAS RN: SEQ103526 Generics group name: INORGANIC CHEMICAL SUBSTANCES (AS DEFINED BY 40 CFR 710.46(B)(3))

CAS RN: 7778-77-0 may be regulated as a member of the Generics group for CAS RN: SEQ516528 Generics group name: POTASSIUM PHOSPHATES (MONO-, DI-, TRIBASIC)

U.S. Federal, TSCA

TSCA IUR 2006, Partially Exempt Inorganic Chemical Substances (40 CFR 710.46(b)(3))

CAS RN: 7778-77-0 may be regulated as a member of the Generics group for CAS RN: SEQ103526 Generics group name: INORGANIC CHEMICAL SUBSTANCES (AS DEFINED BY 40 CFR 710.46(B)(3)) Note(s): iui1

Notes

iui1 40 CFR 710.46(b)(3) Inorganic chemical substances. For purposes of this subpart, an inorganic chemical substance is any chemical substance which does not contain carbon or contains carbon only in the form of carbonato [=CO3], cyano [--CN], cyanato [--OCN], isocyano [--NC], or isocyanato [--NCO] groups or the chalcogen analogues of such groups.

TSCA Interim List of Active Substances (40 CFR 711, as updated through February 2018)

CAS RN: 7778-77-0 may be regulated as a member of the Generics group for CAS RN: 16068- 46-5 Generics group name: Phosphoric acid, potassium salt (1:?)

CAS RN: 7778-77-0

Name: Phosphoric acid, potassium salt (1:1)

TSCA. 2012 Chemical Data Reporting (CDR) Results (13 August 2012)

CAS RN: 7778-77-0

Name: Phosphoric acid, potassium salt (1:1) Activity: I, M

Notes

I Imported

M Manufactured

TSCA Exemption List of Active Substances (as updated through February 2018)

CAS RN: 7778-77-0 may be regulated as a member of the Generics group for CAS RN: 16068- 46-5 Generics group name: Phosphoric acid, potassium salt (1:?) Designation: ACTIVE

CAS RN: 7778-77-0

Name: Phosphoric acid, potassium salt (1:1) Designation: ACTIVE

U.S. Federal, Food and Drugs

USA. Substances Added to Food (formerly EAFUS, as amended through 26 June 2018)

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Technical Effect(s): NUTRIENT SUPPLEMENT; PH CONTROL AGENT; STABILIZER OR THICKENER; MALTING OR FERMENTING AID Synonyms: MONOPOTASSIUM MONOPHOSPHATE; MONOPOTASSIUM PHOSPHATE; ORTHOPHOSPHORIC ACID, MONOPOTASSIUM SALT; PHOSPHORIC ACID, MONOPOTASSIUM SALT; POTASSIUM ACID PHOSPHATE; POTASSIUM DIHYDROGEN PHOSPHATE; POTASSIUM PHOSPHATE, MONOBASIC CFR Food Additive Sections: 175.105 CFR Food Labeling Sections: 101.9; 160.110

FDA. Inactive Ingredients for Approved Drug Products (updated through 15 November 2016)

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: AN,INFILTRATION Dosage Form: INJECTION UNII: 4J9FJ0HL51 Maximum Potency Amount: 2.72 Potency Unit: %

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: AURICULAR (OTIC) Dosage Form: SOLUTION UNII: 4J9FJ0HL51 Maximum Potency Amount: 0.2 Potency Unit: %

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: IM - IV Dosage Form: INJECTION UNII: 4J9FJ0HL51 Maximum Potency Amount: 0.096 Potency Unit: %

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: INTRA-ARTICULAR Dosage Form: INJECTION UNII: 4J9FJ0HL51 Maximum Potency Amount: 0.3 Potency Unit: %

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: INTRAMUSCULAR Dosage Form: INJECTABLE UNII: 4J9FJ0HL51 Maximum Potency Amount: 0.096 Potency Unit: %W/V

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: INTRAMUSCULAR Dosage Form: INJECTION UNII: 4J9FJ0HL51

Maximum Potency Amount: 0.3 Potency Unit: %W/V

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: INTRAUTERINE Dosage Form: SOLUTION UNII: 4J9FJ0HL51

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: INTRAVENOUS Dosage Form: INJECTABLE UNII: 4J9FJ0HL51 Maximum Potency Amount: 0.096 Potency Unit: %

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: INTRAVENOUS Dosage Form: INJECTION UNII: 4J9FJ0HL51 Maximum Potency Amount: 6.8 Potency Unit: %

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: INTRAVENOUS Dosage Form: POWDER, FOR RECONSTITUTION UNII: 4J9FJ0HL51 Maximum Potency Amount: 2.72 Potency Unit: %

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: INTRAVENOUS Dosage Form: SOLUTION, INJECTION UNII: 4J9FJ0HL51 Maximum Potency Amount: 0.085 Potency Unit: %

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: INTRAVESICAL Dosage Form: SOLUTION, INJECTION UNII: 4J9FJ0HL51 Maximum Potency Amount: 2.92 Potency Unit: %

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: IV(INFUSION)

Dosage Form: SOLUTION, INJECTION UNII: 4J9FJ0HL51 Maximum Potency Amount: 1.36 Potency Unit: %

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: NASAL Dosage Form: SOLUTION UNII: 4J9FJ0HL51 Maximum Potency Amount: 0.071 Potency Unit: %

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: NASAL Dosage Form: SPRAY UNII: 4J9FJ0HL51 Maximum Potency Amount: 0.14 Potency Unit: %

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: NERVE BLOCK Dosage Form: INJECTION UNII: 4J9FJ0HL51 Maximum Potency Amount: 2.72 Potency Unit: %

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: OPHTHALMIC Dosage Form: SOLUTION UNII: 4J9FJ0HL51 Maximum Potency Amount: 0.2 Potency Unit: %

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: OPHTHALMIC Dosage Form: SUSPENSION UNII: 4J9FJ0HL51 Maximum Potency Amount: 0.44 Potency Unit: %

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: ORAL Dosage Form: CAPSULE, ENTERIC COATED PELLETS UNII: 4J9FJ0HL51 Maximum Potency Amount: 17 Potency Unit: MG

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: ORAL Dosage Form: EMULSION UNII: 4J9FJ0HL51

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: ORAL Dosage Form: SOLUTION UNII: 4J9FJ0HL51 Maximum Potency Amount: 23 Potency Unit: MG/5ML

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: ORAL Dosage Form: SOLUTION, SYRUP UNII: 4J9FJ0HL51 Maximum Potency Amount: 4.75 Potency Unit: MG/1ML

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: ORAL Dosage Form: SUSPENSION UNII: 4J9FJ0HL51 Maximum Potency Amount: 50 Potency Unit: MG/5ML

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: ORAL Dosage Form: SYRUP UNII: 4J9FJ0HL51 Maximum Potency Amount: 13.66 Potency Unit: MG/5ML

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: ORAL Dosage Form: TABLET UNII: 4J9FJ0HL51 Maximum Potency Amount: 25 Potency Unit: MG

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: ORAL Dosage Form: TABLET, SUSTAINED ACTION UNII: 4J9FJ0HL51 Maximum Potency Amount: 4

Potency Unit: MG

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: SUBCUTANEOUS Dosage Form: INJECTABLE UNII: 4J9FJ0HL51 Maximum Potency Amount: 0.27 Potency Unit: %

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: SUBCUTANEOUS Dosage Form: INJECTION UNII: 4J9FJ0HL51 Maximum Potency Amount: 0.27 Potency Unit: %

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Route: SUBCUTANEOUS Dosage Form: POWDER, FOR INJECTION SOLUTION, LYOPHILIZED UNII: 4J9FJ0HL51 Maximum Potency Amount: 0.12 Potency Unit: %

U.S. Federal, Pesticides

Pesticide Chemical Tolerance Exemptions, Inert Ingredients Used Pre-Harvest (40 CFR 180.920; as amended through 1 August 2018)

CAS RN: 7778-77-0 may be regulated as a member of the Generics group for CAS RN: 16068- 46-5 Generics group name: Dipotassium hydrogen phosphate Uses: Buffering agent

CAS RN: 7778-77-0

Name: Potassium dihydrogen phosphate Uses: Buffering agent

Pesticide Chemical Tolerance Exemptions (40 CFR 180, Subpart D, except Sections 900- 960), as amended through April 13, 2011

CAS RN: 7778-77-0

Name: POTASSIUM DIHYDROGEN PHOSPHATE See 40 CFR: 180.1193

Pesticide Chemical Tolerance Exemptions, Inert Ingredients Used Pre- and Post-Harvest (40 CFR 180.910; as amended through 24 August 2018)

CAS RN: 7778-77-0 may be regulated as a member of the Generics group for CAS RN: 16068- 46-5 Generics group name: Potassium phosphate Group: Potassium phosphate

Use: Buffer

EPA Pesticide Active Ingredients with Registration Status: Conventional Chemicals, Antimicrobial, and Biopesticides (2017)

CAS RN: 7778-77-0

Name: Potassium phosphate, monobasic Registration Status: Registered Pesticide Type: Biopesticides,Conventional Chemical

Inert Ingredients Permitted for Use in Nonfood Use Pesticide Products (April 2011)

CAS RN: 7778-77-0 may be regulated as a member of the Generics group for CAS RN: 16068- 46-5 Generics group name: POTASSIUM PHOSPHATE

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE MONOBASIC (KH2PO4)

NIOSH. Appendix V - Categories of Pesticides, NIOSH Recommendations for Occupational Safety and Health Standards 1992

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC Group III Pesticide: Minimal risk of adverse acute effects even at relatively high doses

U.S. Federal, Right-To-Know

DOE. Protective Action Criteria (PAC) Rev 29: Chemicals with AEGLs, ERPGs or TEELs (May 2016)

CAS RN: 7778-77-0

Name: Potassium phosphate, monobasic PAC-1 is: 9.6 mg/m3. PAC-2 is: 110 mg/m3. PAC-3 is: 630 mg/m3. Unit: mg/m3 mg/m3.

HMIS Chemical Ratings (Hazardous Materials Information System, Chemical Ratings Guide, Third Edition, 2002)

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE MONOBASIC Health Hazard: 1 Slight. Chronic Health Hazard Flammability Hazard: 0 Minimal. Physical Hazard: 0 Minimal.

U.S. State, Texas

Texas, Effects Screening Levels (Texas Commission on Environmental Quality, as amended through 28 June 2018)

CAS RN: 7778-77-0

Name: POTASSIUM DIHYDROGEN PHOSPHATE; PHOSPHORIC ACID MONOPOTASSIUM SALT Phase: PM Short-term must meet NAAQS Long-term must meet NAAQS Short-term Date Derived: 2-Sep-15 Long-term Date Derived: 2-Sep-15 Short-term Status: Final Long-term Status: Final Short-term Basis: Health Long-term Basis: Health

Canada

Canada. Categorization of Existing Substances on DSL (September 2006)

CAS RN: 7778-77-0 may be regulated as a member of the Generics group for CAS RN: 16068- 46-5 Generics group name: PHOSPHORIC ACID, POTASSIUM SALT Substance category: IOG Meets CEPA criteria: No Meets human health criteria: No Meets environmental criteria: No Persistent: Yes Bioaccumulative: No Inherently toxic to aquatic organisms: No

CAS RN: 7778-77-0

Name: PHOSPHORIC ACID, MONOPOTASSIUM SALT Substance category: IOG Meets CEPA criteria: No Meets human health criteria: No Meets environmental criteria: No Persistent: Yes Bioaccumulative: No Inherently toxic to aquatic organisms: No

Notes

IOG Inorganics

Canada. Pest Management Regulatory Agency (PMRA) List of Substance Formulants (Appendix I) (August 31, 2010)

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE, MONOBASIC List: 4B

Notes 4B List 4B includes formulants, some of which may be toxic, for which there are sufficient data to reasonably conclude that the specific use pattern of the pest control product will not adversely affect public health and the environment.

Quebec. Guidance WHMIS Classifications (CSST/SRT) (September 29, 2014)

CAS RN: 7778-77-0

Name: POTASSIUM PHOSPHATE MONOBASIC Classification: UP

Notes

UP Uncontrolled product

Quebec. Guidance WHMIS 2015 Classifications (CNESST) as amended through 14 December 2017

CAS RN: 7778-77-0

Name: Potassium phosphate monobasic (en-US) Additional languages >> NAME Language

Phosphate de potassium monobasique French

Classification Codes: Uncontrolled product Classification: [Uncontrolled product]

OSPAR List of Substances Used and Discharged Offshore which Are Considered to Pose Little or No Risk to the Environment (PLONOR) – Update 2018

(OSPAR Agreement 2013‐06)1

Substances in the PLONOR List 1. The list at Appendix 1 contains substances whose use and discharge offshore is subject to expert judgement by the competent national authority of Contracting Parties. These substances do not normally need to be strongly regulated as, from assessment of their intrinsic properties, the OSPAR Commission considers that they pose little or no risk to the environment.

Criteria for inclusion of substances in the PLONOR List 2. Requests to the Offshore Industry Committee for inclusion of new substances on this list should be accompanied by the appropriate data required to undertake a prior assessment. The data required and the acceptance criteria are the following:

Categories Minimum data required for Acceptance criteria assessment

All substances, including Parts 1 and 3 of HOCNF shall be ‐ Classification with risk phrases inorganic salts (naturally completed, supported by the Safety according to Council Directive 67/548/EEC, occurring or constituents of Data Sheets if necessary. Annex VI does not lead to any of the seawater)i, and natural organic following risk phrases: R50, R50/53, R51, CAS‐number(s) shall be provided if substances which are non‐water R51/53, 52, R52/53, R53ii. they exist soluble (e.g. nutshells, fibres ‐ The substance is not Carcinogenic etc.) (cat 1 & 2)iii, Mutagenic (cat 1 & 2)iii or Toxic for Reproduction (Cat 1, 2 & 3)iii

1 This Agreement replaces OSPAR Agreement 2012‐06. Updated in 2018

1 of 9 OSPAR Commission OSPAR Agreement 2013-06

Classification with hazard statements according to Council Regulation 1272/2008, Annex VI does not lead to any of the following hazard statements: H400, H410, H411, H412, H413ii.

The substance is not Carcinogenic (cat 1A & 1B)iii, Mutagenic (cat 1A & 1B)iii or Toxic for Reproduction (Cat 1A, 1B & 2)iii

In addition:

Soluble organic substances (e.g. - Part 2 of HOCNF: - LC50 or EC50> 100 mg/l, and salts, acids, glycols and alcohols) - literature data or test results - log Pow <3 or BCF<100 or MW>700; and relating to accumulation potential - substance readily biodegradable.

(e.g. log Pow or BCF or Molecular Weight); - literature data or test results relating to biodegradation, in accordance with marine protocols (e.g OECD 306) or freshwater data (e.g. OECD 301 ready series) applying a safety factor of 0.7; - literature data or test results for marine or freshwater toxicity; Insoluble man‐made organic ‐ literature data or test results ‐ substances relating to exposure pathways; e.g. effects on sediment re‐working organisms;

‐ literature data or test results relating to biodegradation.

Minerals ‐ literature data or test results ‐ relating to exposure pathways; e.g. effects on sediment re‐working organisms

Substances exempted under - No additional data - REACH Annex IV requirements

Substances meeting the criteria - Sponsor Contracting Parties - of REACH Annex V will advise on additional data requirements for specific substances

2 of 9 OSPAR Commission OSPAR Agreement 2013-06

Procedure for including new substances in the PLONOR List, for including new CAS Numbers for existing substances on the list, or for removing substances from the List. 3. Any supplier, vendor or organisation wishing to put forward a new candidate substance for inclusion in the PLONOR List, or to add additional CAS numbers to substances already on the PLONOR List, should submit a request to a sponsor Contracting Party. The dataiv for new substances should be submitted in accordance with the criteria above. 4. The sponsor Contracting Party should review the data to ensure that the criteria are met and that they are satisfied with the data presented. If the sponsor Contracting Party considers that the request should be approved, that Contracting Party should then circulate the data, preferably in electronic form, to the List of National Contact Points Concerning Chemicals used Offshore (see the appropriate Annex of the most recent OIC Summary Record) at least 20 weeks before the annual meeting of the Offshore Industry Committee, with a recommendation for inclusion of substances in the PLONOR list or the inclusion of additional CAS numbers for substance already on the list. 5. The national contact points under the lead of the sponsor Contracting Party should work in accordance with the working procedures for intersessional correspondence groups as described in the current version of the Rules of Procedure of the OSPAR Commission. Following receipt of any comments from the national contact points, within the specified deadlines, the sponsor Contracting Party should prepare a final proposal for consideration at the annual meeting of the Offshore Committee. The proposal should be submitted by the sponsor Contracting Party at least six weeks before the annual meeting and should contain a short description of comments or objections raised by Contracting Parties and the way in which the sponsor Contracting Party has taken these comments or objections into account in their final proposal to OIC. 6. Requests to remove substances from the PLONOR list can only be generated by Contracting Parties, and must be the subject of a proposal for consideration at the annual meeting of the Offshore Industry Committee. The proposal should be submitted by the relevant Contracting Party at least six weeks before the annual meeting and must contain a reasoned cause of concern related to the criteria mentioned in paragraph 2 above. Such requests should also be accompanied by the data required for assessment by OIC. 7. Adoption of any proposal submitted to OIC will require the unanimous approval of the Contracting Parties represented at OIC.

3 of 9 OSPAR Commission OSPAR Agreement 2013-06

Appendix

OSPAR List of Substances Used and Discharged Offshore which Are Considered to Pose Little or No Risk to the Environment (PLONOR)

CAS Number EC/List Number Substance / Synonymsv 64‐19‐7 200‐580‐7 Acetic acid 1335‐30‐4 215‐628‐2 Aluminium silicate

12141‐46‐7 235‐253‐8 Aluminium silicate (Al2SiO5)

12068‐56‐3 235‐102‐6 Aluminium silicate (Al6Si2O13) 1318‐93‐0 215‐288‐5 Aluminium silicate (Montmorillonite) 10043‐01‐3 233‐135‐0 Aluminium sulphate

7722‐76‐1 231‐764‐5 Ammonium dihydrogen phosphate ((NH4)H2PO4) 10124‐31‐9 233‐330‐0 Ammonium acid phosphate / phosphoric acid, ammonium salt

(NH3.xH3 PO4) 10192‐30‐0 233‐469‐7 Ammonium bisulphite 12125‐02‐9 235‐186‐4 Ammonium chloride 1336‐21‐6 215‐647‐6 Ammonium hydroxide 10196‐04‐0 233‐484‐9 Ammonium sulphite 9000‐92‐4 232‐567‐7 Amylase 9000‐91‐3 232‐566‐1 Amylase  9032‐08‐0 232‐877‐2 Amylase γ, amylase gluco 9000‐85‐5 232‐560‐9 Amylase, bacterial 9013‐01‐8 232‐742‐8 Amylase, fungal 9067‐73‐6 232‐956‐1 Amylase, iso vi 9005‐84‐9 232‐686‐4 Amylodextrin (starch, soluble) 50‐81‐7 200‐066‐2 Ascorbic acid 89‐65‐6 201‐928‐0 Isoascorbic acid (until 9 January 2015)vii 12174‐11‐7 ‐ Attapulgite clay 1327‐41‐9 215‐477‐2 Basic aluminium chloride 13462‐86‐7 236‐664‐5 Barite 7727‐43‐7 231‐784‐4 Barium sulphate 1302‐78‐9 215‐108‐5 Bentonite 70131‐50‐9 274‐324‐8 Bentonite, acid‐leached 71‐36‐3 200‐751‐6 Butanol (Butan‐1‐ol) 15245‐12‐2 239‐289‐5 Calcium ammonium nitrate 7789‐41‐5 232‐164‐6 Calcium bromide 471‐34‐1 207‐439‐9 Calcium carbonate 1317‐65‐3 215‐279‐6 Calcium carbonate (marble or limestone) 10043‐52‐4 233‐140‐8 Calcium chloride 1305‐62‐0 215‐137‐3 Calcium hydroxide 8061‐52‐7 ‐ Calcium lignosulphate 10124‐37‐5 233‐332‐1 Calcium nitrate 1305‐78‐8 215‐138‐9 Calcium oxide (lime) 10103‐46‐5 233‐283‐6 Calcium phosphate

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CAS Number EC/List Number Substance / Synonymsv

7758‐23‐8 231‐837‐1 Calcium dihydrogen phosphate (Ca(H2PO4)2)

7790‐76‐3 232‐221‐5 Calcium diphosphate (Ca2P2O7) or Dicalcium pyrophosphate

(Ca1/2H4O7P2)

7757‐93‐9 231‐826‐1 Calcium hydrogen phosphate (CaHPO4)

7758‐87‐4 231‐840‐8 Calcium orthophosphate (Ca3(PO4)2) 1592‐23‐0 216‐472‐8 Calcium stearate 7778‐18‐9 231‐900‐3 Calcium sulphate (Gypsum) 9004‐30‐2 Polymer Carboxy methyl hydroxy ethyl cellulosevi, (until 20 November 2014)vii 125494‐51‐1 ‐ Causticized lignitevi (until 11 January 2014)vii 9012‐54‐8 232‐734‐4 Cellulase (until 9 August 2014)vii

65997‐15‐1 266‐043‐4 Cement, Grade G 77‐92‐9 201‐069‐1 Citric acid

65996‐61‐4 265‐995‐8 Cellulose fibre 9004‐34‐6 232‐674‐9 Cellulose crystalline ‐ ‐ Cotton seed hulls 61790‐53‐2 612‐383‐7 Diatomaceous earth 91053‐39‐3 293‐303‐4 Diatomaceous earth, calcined (Kieselguhr calcined) 10034‐77‐2 233‐107‐8 Dicalcium silicate 16389‐88‐1 240‐440‐2 Dolomite 64‐17‐5 200‐578‐6 Ethanol

10028‐22‐5 233‐072‐9 Ferric sulphate 12003‐38‐2 234‐426‐5 Fluorophlogopite (Mica, synthetic) 63‐71‐3 209‐259‐6 Ferrous carbonate 64‐18‐6 200‐579‐1 Formic acid (HCOOH) ‐ ‐ Glass beads 56‐81‐5 200‐289‐5 Glycerine 7782‐42‐5 231‐955‐3 Graphite 7440‐44‐0 931‐328‐0 Carbon 931‐334‐3 9000‐30‐0 232‐536‐8 Guar gum 9004‐62‐0 618‐387‐5 Hydroxyethyl cellulose, 2‐Hydroxyethyl ether cellulose 39421‐75‐5 609‐675‐1 Hydroxypropyl guar gumvi 12168‐52‐4 308‐551‐1 Ilmenite 10290‐71‐8 233‐647‐4 Iron carbonatevi

563‐71‐3 209‐259‐6 Iron carbonate (FeCO3) 62997‐05‐1 613‐129‐8 Iron (II) lignosulphonate 39331‐38‐9 609‐650‐5 Iron lignosulphonate, all oxidation states 1332‐37‐2 215‐570‐8 Iron oxides

1317‐60‐8 215‐275‐4 Iron oxide, Hematite (Fe2O3) 1345‐25‐1 215‐721‐8 Iron (II) oxide (FeO)

1309‐37‐1 215‐168‐2 Iron (III) oxide (Fe2O3)

1317‐61‐9 215‐277‐5 Mixed iron (II + III) oxide / iron oxide (Fe3O4) 67‐63‐0 200‐661‐7 Isopropanol 1332‐58‐7 310‐194‐1 Kaolin

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CAS Number EC/List Number Substance / Synonymsv 63‐42‐3 200‐559‐2 Lactose 8002‐43‐5 232‐307‐2 Lecithin 8030‐76‐0 310‐129‐7 Lecithins, soya (soya beans) 9005‐53‐2 232‐682‐2 Lignin 8002‐53‐7 232‐313‐5 Lignite 1305‐78‐8 215‐138‐9 Lime (calcium oxide) 7786‐30‐3 232‐094‐6 Magnesium chloride 1309‐48‐4 215‐171‐9 Magnesium oxide 68412‐28‐2 270‐182‐6 Magnesium hydroxide (lightly calcinated)vi 1309‐42‐8 215‐170‐3 Magnesium hydroxide 1317‐35‐7 215‐266‐5 Manganese tetraoxide 67‐56‐1 200‐659‐6 Methanol 12001‐26‐2 310‐127‐6 Mica group minerals 107‐21‐1 203‐473‐3 Monoethylenglycol ‐ ‐ Nutshells ‐ ‐ Olive pits ‐ ‐ Polysaccharide containing glucose, mannose and glucoronic acid units 65997‐15‐1 266‐043‐4 Portland cement clinker 584‐08‐7 209‐529‐3 Potash 298‐14‐6 206‐059‐0 Potassium bicarbonate 584‐08‐7 209‐529‐3 Potassium carbonate 7447‐40‐7 231‐211‐8 Potassium chloride 590‐29‐4 209‐677‐9 Potassium formate 7681‐11‐0 231‐659‐4 Potassium iodide, anhydrous 7757‐79‐1 231‐818‐8 Potassium nitrate 16068‐46‐5 240‐213‐8 Potassium phosphate

7758‐11‐4 231‐834‐5 Potassium phosphate dibasic (K2HPO4 or H3O4P.2K)

7778‐53‐2 231‐907‐1 Potassium phosphate tribasic (K3PO4)

7778‐77‐0 231‐913‐4 Potassium phosphate monobasic (KH2PO4)

14887‐42‐4 238‐961‐5 Phosphoric acid, potassium salt (2:1) (KH5(PO4)2) 9005‐25‐8 232‐679‐6 Pregelatinized potato starch 71‐23‐8 200‐746‐9 Propanol 7758‐16‐9 231‐835‐0 Pyrophosphate (sodium acid pyrophosphate; SAPP) 63231‐67‐4 ‐ Silica gel 1343‐98‐2 215‐683‐2 Silicic acid 14808‐60‐7 238‐878‐4 Silica sand 7631‐86‐9 231‐545‐4 Silicon dioxide 127‐09‐3 204‐823‐8 Sodium acetate 532‐32‐1 208‐534‐8 Sodium benzoate 144‐55‐8 205‐633‐8 Sodium bicarbonate 7631‐90‐5 231‐548‐0 Sodium bisulphite

7681‐57‐4 231‐673‐0 Sodium metabisulphite (Na2S2O5) 7647‐15‐6 231‐599‐9 Sodium bromide 497‐19‐8 207‐838‐8 Sodium carbonate (Soda ash)

3313‐92‐6 222‐003‐8 Sodium percarbonate (Na2C2H2O6) 9004‐32‐4 ‐ Sodium carboxymethylcellulose 7647‐14‐5 231‐598‐3 Sodium chloride

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CAS Number EC/List Number Substance / Synonymsv 141‐53‐7 205‐488‐0 Sodium formate 8061‐51‐6 ‐ Sodium lignosulphonate 7631‐99‐4 231‐554‐3 Sodium nitrate

7632‐00‐0 231‐555‐9 Sodium nitrite (NaNO2) 7632‐05‐5 231‐558‐5 Sodium phosphate

7558‐80‐7 231‐449‐2 Sodium dihydrogen phosphate (NaH2PO4)

7601‐54‐9 231‐509‐8 Sodium phosphate (Na3PO4)

7722‐88‐5 231‐767‐1 Sodium pyrophosphate (Na4P2O7)

7758‐29‐4 231‐838‐7 Pentasodium triphosphate (Na5P3O10)

7785‐84‐4 232‐088‐3 Trisodium triphosphate ((NaPO3)3) 10124‐56‐8 233‐343‐1 Sodium polymetaphosphate / Sodium hexametaphosphate

(Na6(PO3)6)

10361‐03‐2 233‐782‐9 Sodium metaphosphate (NaPO3)

14691‐80‐6 238‐735‐6 Trisodium diphosphate (Na3HP2O7) 50813‐16‐6 256‐779‐4 Sodium polymetaphosphate / Metaphosphoric acid, sodium salt) vi 65185‐91‐3 265‐604‐0 Trisodium trihydrogen bis phosphate (Na3(PO4)2) 1344‐09‐8 215‐687‐4 Sodium silicate

6834‐92‐0 229‐912‐9 Sodium metasilicate (Na2SiO3)

13870‐28‐5 237‐623‐4 Disodium disilicate (Na2Si2O5)

13472‐30‐5 236‐741‐3 Tetrasodium orthosilicate (Na4(SiO4))

13870‐30‐9 237‐626‐0 Disodium trisilicon heptaoxide (Na2Si3O7) vi 15593‐82‐5 239‐671‐1 Hexasodium diorthosilicate (Na6Si2O7) 7757‐82‐6 231‐890‐9 Sodium sulphate, anhydrous 7757‐83‐7 231‐821‐4 Sodium sulphite 14986‐84‐6 239‐073‐0 Sodium tetraphosphate

7772‐98‐7 231‐867‐5 Sodium thiosulphate (Na2S2O3) 50‐70‐4 200‐061‐5 Sorbitol 9005‐25‐8 232‐679‐6 Starch (without additives) 68476‐78‐8 270‐698‐1 Sugarcane molasses 12168‐85‐3 235‐336‐9 Tricalcium silicate 57‐13‐6 200‐315‐5 Urea ‐ ‐ Vegetable fibre 1318‐00‐9 ‐ Vermiculite 68608‐58‐2 271‐787‐8 Whey, Protein‐free 92129‐93‐6 Whey lactose low Whey permeate ‐ ‐ Wood fibres 11138‐66‐2 234‐394‐2 Xanthan gum ‐ Polymer High MW hydroxy ethyl cellulose polymer ‐ Polymer Hydroxypropylated cross‐linked corn starch

Hyphen (‐) indicates that no CAS number or EINECS number is available.

No entry ( ) indicates that CAS number or EINECS number has still to be identified.

For guidance on how substances in REACH Annex IV, or substances falling under the criteria in paragraphs 7, 8 or 9 of Annex V, will be assessed by HMCS, please see the pre‐screening document ‘Further Guidance on the Assessment of

7 of 9 OSPAR Commission OSPAR Agreement 2013-06 the Toxicity of Substances under the Harmonised Pre‐Screening Scheme of OSPAR Recommendation 2000/4’ (OSPAR Agreement 2002‐04).

i Does not include salts of heavy metals. ii For Substances classified by risk phrases R50, R50/53, R51, R51/53, R52, R52/53, R53 or hazard statements H400, H410, H411, H412, H413, exceptions can be made from these criteria, providing the properties of the substances are different in seawater (e.g. pH effects of acids, bases, salts). iii Exception can be made based on expert judgement, for exposure routes not relevant to the marine environment, e.g. R49 May cause cancer by inhalation. Under such circumstances, Details of all exposure routes relevant to the CMR properties must be provided, to confirm that there is no evidence of an adverse effect via an exposure route that is relevant to the marine environment. iv Data presented in the HOCNF does not have to have any particular vendor details or tonnage to be used, as PLONOR list items may be supplied by a number of vendors etc. Supplier details and tonnage to be used would have to be provided and considered at the time of use when applying for a permit under national regulations for the implementation of the Harmonised Mandatory Control System under OSPAR Decision 2000/2. However, the sponsor Contracting Party may provide an indication of current tonnage used in their own area, if this information is readily to hand. v The inclusion of a salt in the PLONOR list automatically confers PLONOR status on all hydration states of that salt vi Status to be reviewed following REACH Registration deadline vii Substance will be removed from the PLONOR list on the date indicated if industry does not provide additional data to justify retention on the list.

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9 of 9 OSPAR Commission OSPAR Agreement 2013-06