3,3'-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Bacterial reverse mutation assay: 3,3’-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine was negative with and without metabolic activation in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 (BSL Bioservice, 2005).

Mammalian cytogenicity study: 3,3’-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine was negative, with and without metabolic activation in Chinese hamster lung fibroblasts (V79) (BSL Bioservice, 2006).

Mammalian mutagenicity study: 3,3’-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine was negative, with and without metabolic activation in mouse lymphoma L5178Y cells (BSL Bioservice, 2006).

The studies were conducted according to an appropriate OECD test guideline, and in compliance with GLP.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

3,3’-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine has been tested in a valid bacterial reverse mutation assay (Ames test) conducted according to OECD TG 471 (1997), and under GLP, using S. typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 (Bioservice, 2005).

No increase in the number of revertants was observed in any test strain, with and without metabolic activation, when tested up to cytotoxic concentration. Appropriate solvent, negative and positive controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test. The study was considered reliability 1.

3,3’-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine has been tested in a valid in vitro mammalian chromosome aberration study, conducted according to OECD TG 473 (1997), and under GLP, using chinese hamster lung fibroblasts (V79) (Bioservice, 2005).

No increase in the number of cells with aberrations was observed, with or without metabolic activation, when tested up to cytotoxic concentration. Appropriate solvent and positive controls were inclued and gave expected results. It is concluded that the test substance is negative for the induction of chromosome aberrations to mammalian cells under the conditions of the test. The study was considered reliability 1.

3,3’-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine has been tested in a valid in vitro mammalian gene mutation study, conducted according to OECD TG 476 (1997), and under GLP, using mouse lymphoma L5178Y cells (Bioservice, 2006).

No test substance-induced increase in the number of mutants was observed, with and without metabolic activation, when tested up to cytotoxic concentration. Appropriate solvent, negative and positive controls were included and gave expected results. It is conluded that the test substance is negative for mutagenicity to mammalian cells under the conditions of the test. The study was considered reliability 1.

3,3’-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine contain no structural elements, which may be of concern for potential mutagenic activity. In vitro tests are negative, including bacterial mutagenicity study, mammalian cytogenicity study and mammalian mutagenicity study.

Justification for classification or non-classification

Based on the available data for 3,3’-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine, no classification is proposed for genetic toxicity according to to Regulation (EC) No. 1272/2008.