Registration Dossier
Registration Dossier
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EC number: 701-287-1 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Secondary citations (Klimisch 4) for the component barium chromate (15% of the substance) and/or CrVI:
- Gene mutation: positive in one bacterial strain TA 100 but only when solubilized in NTA (negative unsolubilized or solubilized by NaOH)*
- Increased frequency of sister chromatid exchange in CHO cells. This effect was increased by addition of NTA, however cells were able to absorp the compound by endocytosis without this solvent.*
- Increase in morphological transformation in cultured Syrian hamster embryo cells.**
- Elevated levels of sister chromatid exchange were observed in workers exposed to chromium[VI] compounds in electroplating factories in four out of six studies. Chromosomal aberrations were found in all three studies of exposed workers; an increase frequency of aneuploidy was reported in one study.***
*: source: Cross HJ, Faux SP, Sadhra S et al. Criteria Document for Hexavalent Chromium. International Chromium Development Association. April 1997.
**: source: review: Kerckaert GA, Brauninger R, LeBoeuf RA et al. Use of the Syrian hamster embryo cell transformation assay for carcinogenicity prediction of chemicals currently being tested by the National Toxicology Program in rodent bioassays. Environ Health Perspect. 1996 October; 104(Suppl 5): 1075–1084
***: peer-reviewed source: IARC Monographs on the Evaluation of Carcinogenic Risks to Humans - Volume 49 - Chromium, Nickel and Welding. Last updated: 5 November 1997
Published data also evidenced clastogenic potential and mammalian gene mutation (mainly due to deletion) with barium chromate.
No data on the full registered substance.
Therefore, as human data are available on mutagenicity (but these data only referred to a substance closed to one consituant (15%) of the registered substance), it was considered that the registered substance is classified Muta Cat 3 according to criteria of Directive (EEC) N° 67/548/CEE. Consequently the registered substance is classified M2 under Regulation (EC) 1272/2008.
Short description of key information:
Data on the component barium chromate (15% of the registered substance, only CrVI source) show that it induces gene mutation, aneuploidy and chromosome aberration.
Endpoint Conclusion: Adverse effect observed (positive)
Justification for classification or non-classification
Barium chromate, 15% of the registered substance, has a genotoxic potential when appropriately solubilized, according to secondary literature and also to non-standard (see RSS) clastogenicity and mammalian gene mutation assays.
Therefore the registered substance is considered as a mutagen. However, in the absence of data on in vivo mutagenic potential, no classification is possible. An in vivo test is therefore proposed.
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