Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In vitro Bacterial mutagenicity (Ames test):

Dermalcare MAP L-213/S did not show any mutagenic activity in the bacterial reverse mutation test using Salmonella typhimurium TA1535, TA1537, TA100, TA98 and TA102 in the presence or absence of mammalian metabolic activation (S9).

 

In vitro Micronucleus assay:

Dermalcare MAP L-213/S did not induce any statistically significant increase in the frequency of human lymphocytes with micronuclei, in the presence or absence of a metabolizing system. Dermalcare is therefore considered to be non-clastogenic and non-aneugenic.

In vitro Mammalian cell gene mutation assay:

Dermalcare MAP L-213/S, did not induce any significant increase in the mutation frequency at the HPRT locus in V79 Chinese Hamster Cells, in the presence or absence of a metabolizing system. Dermalcare is therefore considered to be not mutagenic in mammalian cells.


Justification for selection of genetic toxicity endpoint
No specific study was selected since all available in vitro studies were negative.

Short description of key information:
Three in vitro genotoxicity studies are considered to be key studies covering the mutagenic and clastogenic endpoints of genotoxicity.
An Ames test (Sarlang, 2012; OECD 471, Rel. 1), the HPRT test in hamster V79 cells (Verspeek-Rip, 2015; OECD 476 Rel. 1) and a Micronucleus Assay in human lymphocytes (Morris, 2015; OECD 487, Rel. 1) all gave negative results with and without metabolic activation. These studies confirm that Dermalcare MAP L-213/S does not have genotoxic potential.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Harmonized classification:

No harmonized classification is available according to the Regulation (EC) No 1272/2008.

 

Self classification:

Based on the absence of mutagenicity and clastogenicity in in vitro studies, it is concluded that Dermalcare MAP L-213/S is not genotoxic. Therefore no classification is warranted according to the criteria of Annex VI Directive 67/548/EEC or EU Regulation 1272/2008 (CLP).