Ethyl 5-sulphamoyl-o-anisate

Endpoint summary

Description of key information

Skin sensitisation

Key study: OECD 442B and EU method B.51. GLP study. The stimulation indexes were 1.04, 0.91 and 1.37 at concentrations of test item 10%, 25% and 50%, respectively. Therefore, the test item has no sensitisation potential.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Key study: The skin sensitisation potential of the test item was tested according OECD 442B and E.U. B.51 method, following GLP. It was tested on three groups of four mouse CBA/J treated for three consecutive days with 50 µL (25 µL per ear) of the test item diluted at concentrations of 10%, 25% and 50% in dimethylformamide. A control group was treated with dimethylformamide. On day 5, 0.5 mL of BrdU solution (10 mg/mL) was injected by the intraperitoneal route. On day 6, the profileration of lymphocytes in the draining auricular lymph nodes was determined by measurement of BrdU content in DNA of lymphocyte using an ELISA kit. No mortality and no signs of systemic toxicity were noted in the test and control animals during the test. No increase in ear thickness and in ear weight was noted in animals treated at 10%, 25% and 50%. Therefore, the test item has to be considered as not excessively irritant at these concentrations. The Stimulation Index (SI) calculated by individual approach was 1.04, 0.91 and 1.37 for the treated groups at 10%, 25% and 50%, respectively. The EC1.6 cannot be determined in this study.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on available information (SI < 1.6 in the OECD 442B test), the substance is not classified as skin sensitizer according to the CLP Regulation (EC) no. 1272/2008.