Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In three in vitro genetic toxicity tests performed with the read-across source substance WS400128 no mutagenic effects were observed in the absence and presence of metabolic activation. In addition, an in vivo micronucleus test was performed upon request of ECHA confirming absence of genotoxic activity (study report not yet available).
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
As outlined in the „Validity Assessment Report“ for the read-across approach (see IUCLID Section 13) read-across from testing data obtained with the UVCB substance WS400128 is considered appropriate for the safety evaluation as well as classification and labelling of the UVCB substance WS400136 based on the close chemical similarity between the two substances.
There were no statistically significant increases of mutations in three in vitro genetic toxicity studies performed with the read-across source substance.
Based on these results it is concluded that also WS400136 does not necessitate any labelling regarding mutagenicity according to EU classification rules [REGULATION (EC) 1272/2008].Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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