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Administrative data

Key value for chemical safety assessment

Additional information

C16-22-(even numbered)alkylamines (CAS no 68037-92-3) has been tested for genetic toxicity in three in vitro tests.

In the bacterial reverse mutation assay (Ames test), with reliability rating 1, C16-22-(even numbered)alkylamines (CAS no 68037-92-3) did not cause any significant increase in revertant colony numbers of any of the five tested strains at any dose level, either in the presence or absence of metabolic activation (S-9 mix). No evidence of mutagenic potential was seen in this study.

 

It can be stated that in the in vitro chromosome aberration test in human lymphocytes and under the experimental conditions reported, the test item C16-22-(even numbered)alkylamines (CAS no 68037-92-3) did not induce structural and/or numerical chromosomal damage in Chinese hamster cells.

In the in vitro mammalian cell gene mutation test (HPRT-Locus) in Chinese Hamster V79 cells under the experimental conditions reported, the test item C16-22-(even numbered)alkylamines (CAS no 68037-92-3) is considered to be non-mutagenic.


Justification for selection of genetic toxicity endpoint
No specific study has been selected as the conclusion that C16-22-(even numbered)alkylamines (CAS no 68037-92-3) is not genotoxic/mutagenic is based on the three negative in vitro studies available; the Ames test (OECD 471), the chromosome aberration test (OECD 473) and the mammalian cell gene mutation test in the HPRT locus (OECD 476).

Short description of key information:
C16-22-(even numbered)alkylamines (CAS no 68037-92-3) has been tested in three in vitro genotoxicty studies.

The first study available on the substance is the bacterial reverse mutation assay (Ames test) compliant to OECD Guideline 471, performed under GLP and with reliability rating 1. In the study the bacteria strains TA 98, TA 100, TA 1535, TA 1537 and TA 102 of S. typhimurium were exposed to the substance in the presence and absence of S9 mix. There was no evidence of induced mutant colonies over background. This study is classified as acceptable and C16-22-(even numbered)alkylamines (CAS no 68037-92-3 is considered to be non-mutagenic in this bacterial reverse mutation assay.

The second available genetic toxicity study C16-22-(even numbered)alkylamines (CAS no 68037-92-3) is the in vitro mammalian chromosome aberration test in Chinese hamster cells (OECD Guideline 473), which is GLP compliant and has reliability rating 1. In Experiment I and in Experiment II, both in absence and presence of S9 mix, concentrations showing clear cytotoxicity were seen. In both Experiment I and II with metabolic activation precipitation was seen, but not without metabolic activation. The substance is considered to be non-clastogenic in this chromosome aberration test, when tested up to cytotoxic concentrations or precipitating concentrations.

The third genetic toxicity study on the substance is the in vitro mammalian cell gene mutation test (HPRT-Locus) in Chines Hamster V79 cells (OECD 476) which is GLP compliant and have reliability rating 1. In Experiment I and in Experiment II, both in absence and presence of S9 mix, concentrations showing clear cytotoxicity were seen. In conclusion, in the described in vitro cell gene mutagenicity test under the experimental conditions reported, the test item C16-22-(even numbered)alkylamines is considered to be non-mutagenic in the HPRT locus using V79 cells of the Chinese Hamster.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the negative findings in the three available in-vitro tests for genotoxicity, C16-22-(even numbered)alkylamines (CAS no 68037-92-3) does not require classification as a mutagen according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008.