Registration Dossier
Registration Dossier
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EC number: 273-309-3 | CAS number: 68956-56-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In two reverse gene mutation assays in bacteria with two different batches of the substance (low and high content of alcohols), performed according to the OECD guideline 471 and in compliance with GLP, the substance was negative in S. typhimurium strains (TA 1535, TA 1537, TA 98, TA 100 and TA 102) in presence and absence of metabolic activation, up to limit or cytotoxic concentrations.
The substance (batch with high content of alcohols) was also negative in presence and absence of metabolic activation in a chromosome aberration test performed in cultured human lymphocytes performed according to OECD guideline 473 and in compliance with GLP, except an ambiguous response in condition 20h exposure without S9. This result was counterbalanced by a clear negative result in in vitro micronucleus test in the same experimental conditions (20h exposure without S9) in the same test system (cultured human lymphocytes).
The substance (batch with high content of alcohols) was also negative in presence and absence of metabolic activation in a gene mutation test (HPRT) performed according to OECD guideline 476 and in compliance with GLP.
In a bone marrow micronucleus test, performed according to GLP and OECD guideline 474 with camphene, one of the main constituent of the substance, no statistically significant increases in the frequency of micronucleated PCEs or NCEs and PCE:NCE ratios were observed at any dose levels.
Justification for selection of genetic toxicity endpoint
No robust study summary was chosen for this endpoint because more than one study was used to complete this endpoint; therefore, it was not possible to select only one of the studies used for this endpoint.
Short description of key information:
The substance was found negative in the Ames test and the HPRT test. It was also negative in chromosome aberration test except an ambiguous response in condition 20h exposure without S9. However, this result was counterbalanced by a clear negative result in an in vitro micronucleus test in the same experimental conditions (20h exposure without S9) in the same test system (cultured human lymphocytes).
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
As the registered substance is globally negative in all in vitro tests performed (mutagenicity in bacteria, mutagenicity in mammalian cells and clastogenicity tests) and as camphene is negative in an in vivo bone marrow micronucleus test, the susbtance is not classified for mutagenicity according to the annex VI of the Directive 67/548/EEC and the CLP Regulation (EC) No.1272/2008.
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