COMPETENT AUTHORITY REPORT CHLOROPHACINONE (PT 14) Document III-A Active Substance Rapporteur Member State: Spain July 2008 RMS: Spain Chlorophacinone Doc III-A INDEX Section 1: Applicant ________________________________________ 3 Section 2: Identity of active substance __________________________ 4 Section 3: Physical and Chemical properties of active substance ______ 9 Section 4: Analytical methods for detection and identification _______ 17 Section 5: Effectiveness against target organisms and intended uses __ 35 Section 6: Toxicological and metabolic studies __________________ 42 Section 7: Ecotoxicological Profile including Environmental Fate and Behaviour ____________________________________ 349 Section 8: Measures to protect man, animals and the environment ___ 519 Section 9: Classification and labelling ________________________ 523 Section 1: Applicant Page 2 of 524 RMS: Spain Chlorophacinone Doc III-A Section A1 Applicant Annex Point IIA1 1.1 Applicant Name: Liphatech S.A.S Address: Bonnel BP 3, 47480 Pont du Casse, France (Dr Mikaëline Billeret). Telephone: 00 33 5 53 69 XX XX Fax number: 00 33 5 53 69 XX XX E-mail address: : xxxxxxxx@xxxxxxxxxxxxx 1.2 Manufacturer of Name: xxxxxxxxxx Active Substance Address: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx (if different) Telephone: xxxxxxxxxxxxxxxxxx Fax number: xxxxxxxxxxxxxxxxxxxx e-mail address: xxxxxxxxxxxxxxxxxxx Location of manufacturing plant: xxxxxxxxx, xxxxxxxx (address as above). 1.3 Manufacturer of See appropriate Section B1 for details of the manufacturer of the Product(s) biocidal products. (if different) Section 1: Applicant Page 3 of 524 RMS: Spain Chlorophacinone Doc III-A Section A2 Identity of active substance Subsection (Annex Point) Official use only 2.1 Common name Chlorophacinone 2.2 Chemical name 2-[(4-chlorophenyl)phenylacetyl]-1H-indane-1,3-(2H)-dione X1 2.3 Manufacturer´s LM 91 development code number(s) 2.4 CAS No and EC numbers 2.4.1 CAS-No 3691-35-8 2.4.2 EC-No 223-003-0 2.4.3 Other CIPAC No. 208 2.5 Molecular and structural formula, molecular mass 2.5.1 Molecular formula C23 H15 ClO 3 2.5.2 Structural formula O O Cl O 2.5.3 Molecular mass 374.82 2.6 Method of The method of manufacture is confidential to LiphaTech S.A.S. and is manufacture of the presented in the confidential attachment. active substance 2.7 Specification of the The main quantitative method for the determination of chlorophacinone in technical chlorophacinone is a titration. This gives the total purity of the active X2 substance, as chlorophacinone plus related organic impurities (those with an acidic appropriate hydrogen). The chlorophacinone content is calculated by subtracting the content of the the related impurities (determined by HPLC) from the total value. g/kg g/l % w/w % v/v Specification - - >97.8 - 98.8 Analytical 99.3 results 99.9 99.2 99.5 Section 2: Identity Page 4 of 524 RMS: Spain Chlorophacinone Doc III-A Section A2 Identity of active substance Subsection (Annex Point) Reference: IIA2.7/01, Schmit, 2003 2.8 Identity of The identity of impurities and additives is confidential to LiphaTech impurities and S.A.S. and is presented in the confidential attachment. additives, as appropriate 2.8.1 Isomeric Chlorophacinone contains one optically active carbon and therefore composition exists as two enantiomers. As there is only one optically active carbon there are no diastereomers as is the case for certain other active substances. The ratio of the enantiomers in the active substance is confidential information and is provided in the Confidential Information file. 2.9 The origin of the Not relevant. natural active substance or the precursor(s) of the active substance Evaluation by Competent Authorities EVALUATION BY RAPPORTEUR MEMBER STATE Date August 2005 Materials and methods The applicant’s version is adopted. However, there is a mistake in subsection 2.2. (X1 ) This is the CA nomenclature not the IUPAC nomenclature. The correct IUPAC nomenclature is 2-[2-(4-chlorophenyl)-2-phenylacetyl]indan-1,3-dione. Results and discussion The applicant’s version is adopted Conclusion The applicant’s version is adopted Reliability Subsection 2.7: Reliability indicator 1 The rest of the subsections: Reliability indicator 0: Not applicable since no studies were performed for these subsections. Acceptability Acceptable Remarks X2 : There is an editorial mistake in Section 2.7. The sentence is “This gives the total bromadiolone plus related organic…”. Bromadiolone must be corrected to chlorophacinone. Section 2: Identity Page 5 of 524 RMS: Spain Chlorophacinone Doc III-A Section A2.10 Exposure data in conformity with Annex VIIA to Council Annex Point IIA II.2.10 Directive 92/32/EEC (OJ No L, 05.06.1992, p.1) amending Council Directive 67/548/EEC 2.10.1 Human exposure -- Official towards active use only substance 2.10.1.1 Production -- i) Description of The active ingredient is supplied by XXXXXXXXX plant located at process XXXXXXXXXXX. A pre-mix of the active substance is prepared by a fully automated process at the XXXXXX plant. The pre-mix consists of: Active substance + XXXXXXXXXXX + Bittering agent. Two types of pre-mix can be prepared: (1) XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX XX. (2) XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX. The final end-use products (LOGINET SOLIDE and CAID APPATS are non-dusty (see Sections III B1 2.8 and III B2 2.8). LOGINET SOLIDE blocks and CAID APPATS grains are supplied loose and in protective sachets made of LDPE. Packing of the final end used product is automatic for LOGINET SOLIDE blocks and CAID APPATS grains. ii) Workplace Chlorophacinone is manufactured in the EU at XXXXXXX plant near description XXXXXXXXXXX. The manufacturing plant is ISO compliant and Government Approved (a certificate is available). The premix of active substance are manufactured by Liphatech S.A.S plant at Pont du Casse (France). The manufacturing plant is ISO compliant and Government Approved (a certificate is available). Health surveillance and monitoring of all Liphatech personnel is carried out. The health surveillance including blood analysis is done according to the level of exposure for all the personnel involved in the preparation (handling of the actives, the pre-mixes), in the control (laboratory), in administrative tasks in offices located in the plant, or in administrative task out of the plant but having access to the plant (e.g. Liphatech Manager, Marketing and Sells personnel, regulatory affairs etc.). No food or drink are permitted in the factory. iii) Inhalation Handling of the active substances when preparing pre-mixes takes place exposure under strict control procedures, by a restricted number of personnel (2 persons for pure active ingredient; less than 10 persons for pre-mixes). At the end of a production batch and during maintenance, all personnel use full personal protective equipment including closed breathing apparatus and full skin protection in accordance with industrial legislation. No food or drink are permitted in the factory. During packing of the end-used products all personnel (25 persons) use full personal protective equipment (including gloves) in accordance with industrial legislation. Exposure of manufacturing workers is governed by industrial legislation and controlled by the use of automated processes. The active substance is rigorously contained by technical means and exposure of manufacturing workers is prevented. The risk of inhalation exposure of production workers is considered to Section 2: Identity Page 6 of 524 RMS: Spain Chlorophacinone Doc III-A Section A2.10 Exposure data in conformity with Annex VIIA to Council Annex Point IIA II.2.10 Directive 92/32/EEC (OJ No L, 05.06.1992, p.1) amending Council Directive 67/548/EEC be low. iv) Dermal Handling of the active substances when preparing pre-mixes takes place exposure under strict control procedures, by a restricted number of personnel (2 persons for pure active ingredient; less that 10 persons for pre-mixes).. At the end of a production batch and during maintenance, all personnel use full personal protective equipment including closed breathing apparatus and full skin protection in accordance with industrial legislation. No food or drink are permitted in the factory. During packing of the end-used products all personnel (25 persons) use full personal protective equipment (including gloves) in accordance with industrial legislation. Exposure of manufacturing workers is governed by industrial legislation and controlled by the use of automated processes. The active substance is rigorously contained by technical means and exposure of manufacturing workers is prevented. The risk of dermal exposure of production workers is considered to be low. -- 2.10.1.2 Intended use(s) -- 1. Professional users -- i) Description of Professional users (e.g. from private companies and local authorities) are application process trained operators who handle all product types on a daily basis. They can be expected to wear protective clothing (gloves) when handling all products containing chlorophacinone. After use of most products, unused product is likely to be collected and disposed of in a controlled way except when used in sewers where difficulties of access mean that used product is likely to be left after application. ii) Workplace Products containing chlorophacinone are used in sewers, in and around description buildings, in open areas and in waste dumps. Products are generally used in secured bait points to prevent pets, non-target animals and children from reaching the bait. iii) Inhalation Professional users may be potentially exposed by inhalation when exposure handling products, though chlorophacinone is not volatile and formulated as wax blocks, pellets or paste and so the risk of inhalation exposure is low. The products are non-dusty. iv) Dermal Professional users may be potentially exposed by skin contact when exposure applying products or collecting and disposing of uneaten product. 2. Non-professional -- users including the general public (i) via inhalational All products containing chlorophacinone are supplied loose or in contact protective sachets. Products are generally used at secured bait points to prevent access by pets or children.