a redness b chemosis c discharge 9.1.5 Skin Sensitisation (8) Result: Coagulant 122 is not a skin sensitiser in guinea-pigs. Species/strain: Hartley Guinea-Pig Number of animals: 17 males (12 test article, 5 control) Induction: 0.5 mL of test article (100%) was applied to the clipped skin under dressing for 24 hours. A 6-hour contact period was used for subsequent induction applications. The animals were treated with the test article 3 times per week for 3 weeks (total of 9 applications). Challenge: The animals were challenged dermally with the solid test substance for 24 hours 2 weeks after the last induction dose. Results: Table 4 Challenge 24 hrs 48hrs Concentration test control test control 100% 0 0 0 0 Coagulant 122 when applied dermally does not appear to be a dermal sensitiser. Test Method: Modified Buehler Method from USEPA Health Effects Testing Guidelines (3). not performed. Considering that the levels of 9.2 Repeated Dose Toxicity: exposure to Coagulant 122 should be minimal due to protective equipment or mechanical ventilation, it is not considered that any exposure will occur that will reflect repeated dose conditions. 9.3 Genotoxicity 9.3.1 Salmonella typhimurium Reverse Mutation Assay (9) Result: Coagulant 122 was not found to be mutagenic. (strains TA1535, TA1537, TA98 & TA 100) Strains: Salmonella typhimurium
a redness b chemosis c discharge 9.1.5 Skin Sensitisation (8) Result: Coagulant 122 is not a skin sensitiser in guinea-pigs. Species/strain: Hartley Guinea-Pig Number of animals: 17 males (12 test article, 5 control) Induction: 0.5 mL of test article (100%) was applied to the clipped skin under dressing for 24 hours. A 6-hour contact period was used for subsequent induction applications. The animals were treated with the test article 3 times per week for 3 weeks (total of 9 applications). Challenge: The animals were challenged dermally with the solid test substance for 24 hours 2 weeks after the last induction dose. Results: Table 4 Challenge Concentration 24 hrs 48hrs test control test control 100% 0 0 0 0 Coagulant 122 when applied dermally does not appear to be a dermal sensitiser. Test Method: Modified Buehler Method from USEPA Health Effects Testing Guidelines (3). 9.2 Repeated Dose Toxicity: not performed. Considering that the levels of exposure to Coagulant 122 should be minimal due to protective equipment or mechanical ventilation, it is not considered that any exposure will occur that will reflect repeated dose conditions. 9.3 Genotoxicity 9.3.1 Salmonella typhimurium Reverse Mutation Assay (9) Result: Coagulant 122 was not found to be mutagenic. Strains: Salmonella typhimurium (strains TA1535, TA1537, TA98 & TA 100)
NA297FR.docx