animal slight redness on days 1 and 2; 2 animals exhibited slight chemosis on day 1, 1 animal moderate chemosis on day 1 and mild chemosis on days 2 and 3; 2 animals exhibited slight discharge on day 1, 1 animal mild discharge on day I and slight discharge on days 2 and 3. 9.1.6 Skin Sensitisation (3) non-sensitiser Result: Guinea pig/ Dunkin/Hartley 20 test, 10 control Species/strain.’ Number of animals: Three pairs of injections of 0.1 mL: FCA in water (1:1); 0.25% notified chemical Induction.’ in Alembicol D with and without FCA (1:1). Topical induction: at day 6, 0.2 mL 10% sodium lauryl sulphate in petrolatum followed 1 day later by 0.4 mL neat notified chemical for 48 hours. use of 5O% and 100% v/v notified chemical produced reactions in the controls Results.’ which, while not suggestive of sensitisation, made scoring imprecise. Therefore a second challenge was conducted one week later as follows: Challenge 24 hrs 48 hrs Concentration test control test control 25% 0/20 0/10 0/20 0/10 5O% 0/20 0/10 0/20 0/10 based on OECD Guidelines for Testing Chemicals (4). Test Method.’ Repeated Dose Toxicity Not supplied. This was acceptable as will be minimal potential for repeated occupation exposure under normal use situations. Genotoxicity Salmonella typhimurium Reverse Mutation Assay (6) non-mutagenic Result: TA 98, TA 100, TA 1S3S, TA 1S37, TA 1S38 and Strains.’ Salmonella typhimurium WP2uvrA Escherichia coli 33 - 10000 ~ig/ plate with and without rat liver S9 Concentration range.’ based on OECD Guidelines for Testing Chemicals (4). Test Method.’
animal slight redness on days 1 and 2; 2 animals exhibited slight chemosis on day 1, 1 animal moderate chemosis on day 1 and mild chemosis on days 2 and 3; 2 animals exhibited slight discharge on day 1, 1 animal mild discharge on day I and slight discharge on days 2 and 3. 9.1.6 Skin Sensitisation (3) Result: non-sensitiser Species/strain.’ Guinea pig/ Dunkin/Hartley Number of animals: 20 test, 10 control Induction.’ Three pairs of injections of 0.1 mL: FCA in water (1:1); 0.25% notified chemical in Alembicol D with and without FCA (1:1). Topical induction: at day 6, 0.2 mL 10% sodium lauryl sulphate in petrolatum followed 1 day later by 0.4 mL neat notified chemical for 48 hours. Results.’ use of 5O% and 100% v/v notified chemical produced reactions in the controls which, while not suggestive of sensitisation, made scoring imprecise. Therefore a second challenge was conducted one week later as follows: Challenge Concentration 24 hrs 48 hrs test control test control 25% 0/20 0/10 0/20 0/10 5O% 0/20 0/10 0/20 0/10 Test Method.’ based on OECD Guidelines for Testing Chemicals (4). Repeated Dose Toxicity Not supplied. This was acceptable as will be minimal potential for repeated occupation exposure under normal use situations. Genotoxicity Salmonella typhimurium Reverse Mutation Assay (6) Result: non-mutagenic Strains.’ Salmonella typhimurium TA 98, TA 100, TA 1S3S, TA 1S37, TA 1S38 and Escherichia coli WP2uvrA Concentration range.’ 33 - 10000 ~ig/ plate with and without rat liver S9 Test Method.’ based on OECD Guidelines for Testing Chemicals (4).
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