Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

In Ames test, the evaluation of the mutagenic potential using S. Tryphimurium and E. Coli, following the conditions described in the OECD Guidlines Nos 471 and 472 (OECD, 1983a and 1983b), gave an unequivocal positive, ie mutagenic, response of the Substance in strains TA1538, TA98 and TA100 in both the presence and absence of an auxiliary metabolising system (S9). But

the compound did not induce any significant, reproducible increases in the observed numbers of revertant colonies in strains TA1535 and WP2 uvrA pKM101 in either the presence or absence of S9.

Furthermore, the results of the Micronuleus test on mice, witch is an in vivo test and is more reliable than Ames test, indicate that the Substance is not clastogenic.

Thus, the Substance is not classified as mutagenic.