Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Pigment Red 52(Sr) is not genotoxic in vitro based on experimental data with pigments of the same category.

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
See read-across justification
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Species / strain:
E. coli WP2 uvr A pKM 101
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No experimental data is available for Pigment Red 52(Sr), however sufficient data on genetic toxicity is available for substances of the same category.

In vitro mutagenicity in bacteria

Experimental data is available data from Pigment Red 57:1(Ca), 57(Sr), 48:1(Ba), 48:2(Ca), 48:4(Mn), 52:2(Mn). The most relevant experimental data on mutagenicity in bacteria is available for Pigment Red 57(Sr) as well as Pigment Red 52:2(Mn). The mutagenicity in vitro of Pigment Red 57(Sr)was assessed in two tests applying both the standard assay with rat liver homogenate and the modified assay for azo compounds (Prival-assay). The studies were performed following the latest OECD testing guideline (OECD 471) and the principles of GLP. The standard test was performed with doses of 7.88, 19.5, 39.1, 78.1, 156 and 313 μg/plate using the pre-incubation method and DMSO as vehicle, and included all five tester strains (DIC 2005a). The assay with the Prival modification was performed with Salmonella typhimurium TA 1535, TA 100, TA 1537, TA 98 and doses of 0, 20, 100, 500, 2500 and 5000 μg/plate in DMSO were applied (BASF AG 1992). The difference in the sulfonated phenyl part is considered acceptable because the sulfonated amine (CAS 88-53-9) that would be derived from azo reduction of Pigment Red 52(Sr) was found to be non-mutagenic in two tests. One test was sponsored by MHWL and its short summary as well as the report in Japanese language have been published by the Japanese Competent Authority. From the available information, this study appears to be valid without restriction. The other test was sponsored by BASF in 1981 and is considered to be valid with restrictions as it was performed prior to the introduction of GLP and did not use the standard five tester strains. For Pigment Red 52:2, mutagenicity was investigated in a standard Ames test following the OECD testing guideline 471 and the principles of GLP and no indication of mutagenic properties were observed at the limit dose in Salmonella typhimurium strains TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA (BASF AG 2006). This study is considered valid without restriction. Its only fallback is that the content of the pigment is only 54%. This is however considered acceptable because limit doses were tested and the BONA metal laked pigments precipitated at lower doses. Also the other Pigments are non-mutagenic in the Ames tests.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for genetic toxicity according to Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008.