Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Read across from BaCl2*2H2O to Ba(OH)2:

Based on the negative results in thein-vitrotest for the soluble barium compound (BaCl2; 263 g/L; 20 -25°C) and assuming that the mutagenic/genotoxicity effects will be based on the cation concentration, read across to the soluble Ba(OH)2(37.4 g/L; 20°C) is considered to be justifiedand will likely lead to rather conservative no-effect levels.

Short description of key information:

in-vitro gene mutation in bacteria (OECD 471): negative

in-vitro gene mutation in mammalian cells (OECD 476): negative

in-vitro chromosome aberration (OECD 473): negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Tests on the mutagenic potential of barium compounds in bacteria are considered dispensable for principal considerations, since inorganic metal compounds are frequently negative in this assay due to limited capacity for uptake of metal ions (Guidance on information requirements and chemical safety assessment, Chapter R.7a, p. 387; HERAG facts sheet mutagenicity, Chapter 2.1).

However, a study was made available by NTP (1994) using barium chloride as test material. Salmonella typhimurium TA97, TA 1535, TA 1537, TA 98 and TA 100 strains were used. Test concentrations fo 100, 333, 1000, 3333, 10000 µg/plate were chosen with and without metabolic activation. No increased induction of revertant colonies at all concentrations in all strains with and without metabolic activation could be observed.

It is concluded that the in vitro chromosome aberration test in CHO cells was negative with and without metabolic activation. Concentrations were tested between 50 and 5000 µg/mL.