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Administrative data

Key value for chemical safety assessment

Additional information

The mutagenic potential of DOPA-Glycinate was tested in the bacterial reverse mutation test using the plate incorporation assay. The study was conducted according to OECD guideline 471 (1997). The substance was tested up to cytotoxic concentrations.No increase in the number of revertant colonies was found in any of the tested strains with or without metabolic activation while the positive controls gave the expected increase in the mean number of revertant colonies. Under the conditions of this study, the test item dissolved in water was not mutagenic.

The clastogenic potential of DOPA-Glycinate was tested in human lymphocytes. The study was carried out according to OECD guideline 473 (1983). The substance was tested up to cytotoxic concentrations. The test item did not induce structural chromosome damage in cultured human lymphocytes either in the presence or in the absence of S9-mix.

The in vitro genotoxicity of DOPA-Glycinate was tested in Chinese hamster ovary cells (HPRT assay). The study was carried out according to OECD guideline 476 (1984). The substance was tested up to cytotoxic concentrations. In the absence and in the presence of a metabolic activation system, the test item did not induce a significant increase in the mutant frequency in both independent assays.

Based on the overall negative results of in vitro genotoxicity testing, DOPA-Glycinate may be regarded as void of any genotoxic potential. In conclusion, there is no need to carry out in vivo tests for genetic toxicity. There are no data gaps for this endpoint.

No human data are available for genetic toxicity. However, there is no reason to believe that the negative results would not be relevant to humans.


Justification for selection of genetic toxicity endpoint
No single key study has been selected since all available studies were negative.

Short description of key information:
Negative in all tests conducted:
- Ames test with S. typhimurium TA 98, TA 100, TA 1535, TA 1537, E coli WP2 (met. act.: with and without) (OECD TG 471, GLP); tested up to cytotoxic concentrations
- Mammalian cell gene mutation assay with CHO cells (HPRT test) (met. act.: with and without) (OECD Guideline 476, pre-GLP); tested up to cytotoxic concentrations
- In vitro mammalian chromosome aberration test with cultured human lymphocytes (met. act.: with and without) (OECD Guideline 473, pre-GLP); tested up to cytotoxic concentrations

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

DOPA-Glycinate is not mutagenic in the Salmonella typhimurium reverse mutation assay and the mammalian cell gene mutation assay using CHO cells. In an in vitro chromosomal aberration test, the test item did not induce structural chromosomal aberrations. Therefore, DOPA-Glycinate is considered to be non-clastogenic.

In conclusion the full set of genotoxicity tests required by the REACH regulation is negative. According to Directive 67/548/EEC as well as GHS Regulation EC No 1272/2008 no classification and labelling for mutagenic toxicity is necessary.