Registration Dossier
Registration Dossier
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EC number: 202-282-2 | CAS number: 93-84-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The test substance (purity: 99.7% = current quality) revealed positive results in a recent Bacterial Reverse Mutation Tests in straines TA 98 and TA 1537 only in the absence of metabolic activation. Due to impurities of the test substance (purity: 88% = former quality) positive results were also seen in strains TA 98, TA 100, TA 1537 and TA1538 in the absence and in the presence of metabolic activation in a previuous study (1991).
Negative results were obtained in a micronucleus study in vivo.
Short description of key information:
OECD 471 AMES (KEY_471_2009_HARLAN_1280600): positive
OECD 471 AMES (NONKEY_471_1991_HOECHST_90.0468): positive
OECD 474 Micronucleus in vivo (NONKEY_474_1994_HOECHST_94.0294): negative
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Findings in genetic toxicity studies i.e. positve results in the AMES Test in the absence of metabolic activation and negative results in the Micronucleus Test in vivo, do not meet criteria for classification according to 67/548/EEC (2.2 DSD-DPD) or REGULATION (EC) No 1272/2008 (2.1 GHS). Therefore classification is not warrantable.
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