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Human Health (PDF) Human & Environmental Risk Assessment on ingredients of European household cleaning products Fatty Acid Salts Human Health Risk Assessment Draft for Public Comment June, 2002 All rights reserved. No part of this publication may be used, reproduced, copied, stored or transmitted in any form of by any means, electronic, mechanical, photocopying, recording or otherwise without the prior written permission of the HERA Substance Team or the involved company. The content of this document has been prepared and reviewed by experts on behalf of HERA with all possible care and from the available scientific information. It is provided for information only. HERA cannot accept any responsibility or liability and does not provide a warranty for any use or interpretation of the material contained in this publication. HERA Targeted Risk Assessment of Fatty Acids Salts, June 2002 Contents 2. Executive Summary ____________________________________________________ 3 3. Substance Characterisation ______________________________________________ 4 3.1. CAS No and Grouping information 4 3.2. Chemical structure and composition 4 3.3 Manufacturing Route and Production/Volume Statistics 6 3.4. Use applications summary 6 5. Human Health Assessment_______________________________________________ 8 5.1 Consumer Exposure 8 5.1.1 Product types ____________________________________________________________________ 8 5.1.2 Consumer Contact Scenarios ________________________________________________________ 8 5.1.3 Consumer contact estimates_________________________________________________________ 9 5.2 Hazard Assessment ______________________________________________________ 14 5.2.1 Summary of available toxicological data 14 5.2.1.1 Acute Toxicity ________________________________________________________________ 15 Acute Dermal Toxicity ________________________________________________________________ 16 5.2.1.2 Corrosiveness/Irritation__________________________________________________________ 17 5.2.1.3 Sensitisation __________________________________________________________________ 20 5.2.1.4 Repeated Dose Toxicity _________________________________________________________ 21 5.2.1.5 Genetic Toxicity _______________________________________________________________ 23 5.2.1.6 Carcinogenicity ________________________________________________________________ 24 5.2.1.7 Toxicity to Reproduction ________________________________________________________ 25 5.2.1.8 Developmental Toxicity / Teratogenicity ____________________________________________ 26 5.2.1.9 Toxicokinetics_________________________________________________________________ 27 5.2.2 Identification of critical endpoints 28 5.2.2.1 Overview on Hazard identification_____________________________________________ 28 5.2.2.2 Rationale for identification of critical endpoints __________________________________ 29 5.2.2.3 Determination of NOAEL or quantitative evaluation of data _________________________ 29 5.3 Risk Assessment ________________________________________________________ 29 5.3.1 Margin of Exposure Calculation 29 5.3.1.1 Exposure scenario: direct skin contact from hand washed laundry_________________________ 29 5.3.1.2 Exposure scenario: direct skin contact from contact via pretreatment of clothes ______________ 30 5.3.1.3 Exposure scenario: indirect skin contact from transfer from clothing ______________________ 30 5.3.1.4 Exposure scenario: Inhalation of laundry powder dust & inhalation of sprays generated by aerosols __________________________________________________________________________________ 30 5.3.1.5 Exposure scenario: Accidental Exposure ____________________________________________ 31 5.3.1.6 Exposure scenario: Total Consumer Exposure ________________________________________ 31 5.3.2 Risk Characterisation 32 5.4 Discussion and Conclusions ______________________________________________ 33 6. References ___________________________________________________________ 34 Appendix I ________________________________________________________________ 38 Appendix II________________________________________________________________ 42 Page 2 of 45 HERA Targeted Risk Assessment of Fatty Acids Salts, June 2002 2. Executive Summary Fatty acid salts (soap) are a widely used class of anionic surfactants. They are used in household cleaning products, cosmetics, lubricants (and other miscellaneous industrial applications) and coatings. Uses in household cleaning products, the scope of this HERA assessment, include fabric washing products, fabric conditioners, laundry additives, and surface and toilet cleaners. According to data received from a survey conducted among detergent formulator companies, an overall annual tonnage of 71306 tonnes of fatty acid salts for use in HERA applications was estimated. This was compiled using data from 4 out of the 6 main formulator companies. Fatty acid salts are of low acute toxicity. Their skin and eye irritation potential is chain length dependent and decreases with increasing chain length. They are not skin sensitisers. The available repeated dose toxicity data demonstrate the low toxicity of the fatty acids and their salts. Also, they are not considered to be mutagenic, genotoxic or carcinogenic, and are not reproductive or developmental toxicants. Accidental ingestion of fatty acid salt containing detergent products is not expected to result in any significant adverse health effect. This assessment is based on toxicological data demonstrating the low acute oral toxicity of fatty acid salts and the fact that not a single fatality has been reported in the UK, following accidental ingestion of detergents containing fatty acid salts. The estimated total human exposure to fatty acid salts, from the different exposure scenarios for the handling and use of detergent products containing fatty acid salts, showed a margin of exposure (MOE) of 258,620. This extremely large MOE is large enough to be reassuring with regard to the relatively small variability of the hazard data on which it is based. Also, in the UK, the recommended dietary fatty acid intake by the Department of Health is about 100 g of fatty acids per day or 1.7 g (1700 mg) of fatty acids per kilogram body weight per day. This exposure is several orders of magnitude above that resulting from exposure to fatty acid salts in household cleaning products. Based on the available data, the use of fatty acid salts in household detergent and cleaning products does not raise any safety concerns with regard to consumer use. Page 3 of 45 HERA Targeted Risk Assessment of Fatty Acids Salts, June 2002 3. Substance Characterisation Fatty acid salts are a widely used class of anionic surfactants. The applications which are covered by the scope of HERA include use in fabric washing products, fabric conditioners, laundry additives, and surface and toilet cleaners. In addition, there are a number of uses which are not covered by HERA. These include cosmetics, lubricants (and other miscellaneous industrial applications) and use in coatings. 3.1. CAS No and Grouping information The category for this assessment is defined as the salts of monocarboxylic acids bearing a straight, even numbered fatty acid chain, ranging in number of carbon atoms from 10 to 22. The C16 to C22 members of the group may be saturated or unsaturated (unsatd) with a carbon-carbon double bond. The fatty acids salts grouping consists of both discrete chemicals with an incremental and constant change across its members (carbon chain length) and commercial mixtures that are composed of fatty acids salts with a range of carbon chain lengths. The chemical structure of the category is: O Na RCHO K where R contains from 9 to 21 carbon atoms and the higher fatty acid chain lengths may be saturated or unsaturated, with potassium or sodium salts included. 3.2. Chemical structure and composition Table 1 covers the CAS numbers provided by 4 out 6 formulator companies. Although clearly important from a Regulatory perspective, the environmental assessment is not based on CAS Nos., but on the product composition and specifically carbon chain length distribution - which is key to the environmental profile of this family. Whilst fatty acids are used in the initial starting list of materials, the final formulation of products covered through this assessment can be expected to contain only fatty acid salts. Thus, the salts of fatty acids only are considered here. Data for fatty acids have been used only for (comparative) read across purposes in the absence of data for the salts. Page 4 of 45 HERA Targeted Risk Assessment of Fatty Acids Salts, June 2002 Table 1 – Chemicals, CAS Numbers, Synonyms, and Structural Composition CAS No. Compound Synonyms Chain length Fatty Acid Salts 629-25-4 Dodecanoic acid, sodium salt Sodium laurate 12 143-18-0 9-Octadecenoic acid, potassium Oleic acid, potassium 18 salt salt; Potassium oleate 143-19-1 9-Octadecanoic acid, sodium salt Oleic acid, sodium salt; 18 Sodium oleate 822-16-2 Octadecanoic acid, sodium salt Stearic acid, sodium 18 salt; Sodium stearate 2272-11-9 9-Octadecanoic acid (Z)-, compd Monoethanolamine 20 with 2-aminoethanol (1:1) oleate 85408-69-1 Fatty acids, C8-C18 and C16-18 - 16-18 unsatd. Sodium salts Fatty Acids 143-07-7 Dodecanoic acid Lauric acid 12 90990-09-3 Fatty acids, C10-14 - 10-14 67701-01-3 Fatty acids, C12-18 - 12-18 67701-03-5 Fatty acids, C16-18 - 16-18 67701-06-8 Fatty acids, C14-18 and C16-18 - 14-18 unsatd 85711-54-2 Fatty acids, rape oil - 18-22 68424-37-3 Fatty acids C14-C22 - 14-22 Due to the limited availability of
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