Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The data discussed in this section were derived from toxicity studies with the hydrochloride of the same azo dye (read-across to Basisch Gelb 8511, CAS 118208-02-9).

Basazol Gelb 8511 was tested in the following guideline tests: Two Salmonella typhimurium/E.coli Reverse Mutation Assays (OECD TG 471), the in vitro Mammalian Chromosme Aberration Test in human lymphocytes (OECD TG 473), the Mouse Spot Test (ECC 87/302) and in the Mouse Micronucleus Test (OECD TG 474). In one Ames test Basazol Gelb 8511 was mutagenic with metabolic activation in the standard plate test in S. typhimurium strain TA 1537 (BASF AG, 1998). In another Ames test the test substance was mutagenic with metabolic activation in S. typhimurium strains TA 100 and TA 1537, E. coli WP2 uvrA in the preincubation test (BASF AG, 1990). Basazol Gelb 8511 showed no genotoxic effect in the cytogenetic assay with human lymphocytes and in vivo in the Mouse Spot test and Mouse Micronucleus test (BASF AG, 1990 & 1991 a+b).


Short description of key information:
Basazol Gelb 8511 was mutagenic with metabolic activation in S. typhimurium strains TA 100 and TA 1537, E. coli WP2 uvrA in one Ames test (preincubation test; BASF AG, 1990) and with metabolic activation in S. typhimurium strain 1537 in a second Ames test (standard plate test, BASF AG, 1998). Basazol Gelb 8511 showed no genotoxic effect in the cytogenetic assay with human lymphocytes and in vivo in the Mouse Spot test and Mouse Micronucleus test (BASF AG, 1990 & 1991 a+b).

Endpoint Conclusion:

Justification for classification or non-classification

EU classification according to Annex VI of the Directive 67/548/EEC:

No classification.

GHS classification according to Annex I 1272/2008 CLP (EU GHS):

No classification.