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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

The test item (C.I. Pigment Red 168) did not induce gene mutations by frameshifts or base-pair substitutions in the genome of the strains used when tested in a bacterial reverse mutation assay (Ames test, test strains: Salmonella typhimurium TA 98, TA 100, TA 1535, TA1537; E. coli WP2 uvrA) with and without metabolic activation (rat liver S9) at up to 5000 µg/plate. Since the test item did not induce gene mutations Pigment Red 168 is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.

Pigment Red 168 was not genotoxic in the mammalian cell gene (HPRT) mutation test in V79 Chinese Hamster cells when tested with and without rat liver S9 metabolic activation at concentrations up to 4640 µg/mL.

The test item Pigment Red 168 was not clastogenic in the mammalian cell chromosome aberration test in V79 Chinese Hamster cells when tested with and without rat liver S9 metabolic activation at concentrations up to 500 µg/mL.


Justification for selection of genetic toxicity endpoint
Evaluation of genetic toxicity is based on a battery of different study protocols comprising in the case of consideration:
KEY_471_2005_RCC_863605,
KEY_473_2012_Harlan CCR_1443201,
KEY_476_2012_Harlan CCR_1443202

Short description of key information:
Mutagenic properties of Pigment Red 168 were investigated in a bacterial reverse mutation assay (Ames test; tester strains used: S. typhimurium TA 98, TA 100, TA 1535, and TA 1537 and E. coli WP2 uvr A), in an in vitro gene mutation study in mammalian cells (HPRT assay in V79 cells) and in a mammalian cell chromosome aberration test in V79 cells. Negative results were obtained in all tests with and without exogenous metabolic activation.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Pigment Red 168 does not have to be classified for mutagenicity according to the criteria laid down in Directive 67/548/EEC and in Regulation (EC) No 1272/2008 because Pigment Red 168 did not reveal any mutagenic effect in the bacterial reverse mutation assay in the presence or absence of metabolic activation at concentrations up to 5000 µg/plate, in the in vitro gene mutation study in mammalian cells (HPRT assay in V79 cells) at up to a precipitating concentration of 4640 µg/mL and in the mammalian cell chromosome aberration test in V79 cells at up to a precipitating concentration of 500 µg/mL.