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Administrative data

Key value for chemical safety assessment

Additional information

There exist the following mutagenicity studies with full reliability:

- in-vitro gene mutation in bacteria (Zeiger et al. 1992),

- in-vitro gene mutation in mammalian cells (Stone, 2010) and the

- in-vivo micronucleus test (NTP, 2000).

The in-vitro micronucleus test (Gibson et al. 1997) has also a sufficient but no full reliability.

Not sufficiently reliable are the sudies of Kerckaert et al. (1996), cell transformation test in SHE cells, and of Duerksen-Hughes et al. (1999), p53 induction in vitro. They used no standard study protocol and the specificity and selectivity of their test system has not been proven sufficiently reliable, therefore these 2 studies are ignored.

Husgavfel-Pursiainen et al. (1990) published results from a sister-chromatid exchange study and a chromosome aberration study in GaAs exposed CHO cells. Both studies showed negative results. However, these studies were considered as not assignable and could not be evaluated for their reliability due to availability as abstracts only.

The studies with sufficient reliability are negative and clearly show that GaAs is not mutagenic or genotoxic.


Short description of key information:
The following mutagenicity studies with sufficient reliability are available: in-vitro gene mutation in bacteria (Zeiger et al. 1992), in-vitro micronucleus test (Gibson et al. 1997), in-vitro gene mutation in mammalian cells (Stone, 2010) and in-vivo micronucleus test (NTP, 2000).

All study results are negative for the respective endpoints. In conclusion, the results of these studies clearly show that GaAs is not mutagenic or genotoxic. A classification with regard to genotoxicity is not required.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Results of the studies with sufficient reliability are negative and clearly show that GaAs has no genotoxic or mutagenic effects.

Therefore a classification according to CLP regulation (and of course according to Directive 67/548/EEC) and subsequent regulations with regard to mutagenicity or genotoxicity is not required.