Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The substance was negative in the following tests:
1) Ames Test – salmonella & E. coli
2) In Vivo Mammalian Erythrocyte Micronucleus Test
No effects were noted in any of the studies conducted. A repeat dose study with oral treatment in rats did not reveal any tumorigenic properties which could be related to the administration of the test substance. Consequently, the substance is considered not to be potentially mutagenic.
Justification for selection of genetic toxicity endpoint
A study was not selected as the substance was negative in an in vitro Ames test and in an in vivo mammalian erythrocyte micronucleus test.
Short description of key information:
The substance was negative in the following tests:
1) Ames Test – salmonella & E. coli
2) In Vivo Mammalian Erythrocyte Micronucleus Test
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The above studies have all been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP and in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.
The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for genetic toxicity is therefore required.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
