Registration Dossier
Registration Dossier
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EC number: 200-782-5 | CAS number: 72-48-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Justification for classification or non-classification
In total 11 in vitro studies and 1 in vivo study assessing the genotoxicity of the test substance are available. A weight of evidence approach was taken to assess the genetic toxicity potential of the test item:
- 4 in vitro gene mutation studies (Ames) are available. In 2 studies (1992 and 2010) negative results were obtained. Positive results were described in two other Ames tests (1976 and 1990). These positive test results can however be ignored as (1) no clear dose response pattern was observed in the 1976 study and (2) only two strains were tested in the 1990 study. Furthermore, in 1990 study, the positive results observed for TA 1537 with metabolic activation (+ S9) are contradictory to the positive result also found for the same strain TA1537 without S9 metabolic activation. Overall, taking into account the flaws identified for the different available Ames tests, it can be concluded that the results are negative.
- 5 in vitro DNA damage and/or repair studies are available. In one study (1990) significant unscheduled DNA synthesis was observed at test concentration 50 and 100 µg/ml in a dose-range dependent way. The other 4 DNA damage and/or repair studies gave clear negative results. Taken together all test results, the outcome should be regarded as negative.
- 2 in vitro gene mutation studies in mammalian cells have been conducted. Both studies had a negative outcome.
- 1 in vivo mammalian cell study was available, which shows a negative result at the tested concentration.
Taking all available in vitro data together in a weight of evidence approach, results in an overall negative outcome for genotoxicity. This is further supported by the in vivo study. In conclusion, the substance should not to be considered as genotoxic/mutagenic according to Regulation EC No 1272/2008, section 3.5.
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