Registration Dossier
Registration Dossier
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EC number: 402-860-6 | CAS number: 110553-27-0 CG 25-1320; IRGANOX 1520; TK 12229/1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The substance was negative in the following tests:
Bacterial reverse mutation test
In Vitro Mammalian Cell Gene Mutation Test in Chinese Hamster Cells V79
In vivo micronucleus test in Chinese Hamster
The bacterial reverse mutation test showed that the substance does not have any mutagenic properties in different Salmonella strains. In addition, no genotoxic properties have been seen in the chromosome aberration test or the mouse micronucleus test. Repeat-dose studies with oral treatment in rats did not reveal any tumorigenic properties which could be related to the administration of the test substance. Consequently, additional testing of the test substance in an in vitro gene mutation study in mammalian cells does not appear scientifically necessary and this test has been waived.
The following information is taken into account for any hazard / risk assessment:
Genetic toxicity "in vitro" is discussed below.
Value used for CSA:Genetic toxicity: negative
Short description of key information:
Summary of genetic toxicity tests
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 Klimish et al system. This ranking was deemed appropriate because the studies were all conducted to GLP in compliance with recognised guidelines. The majority of the information has been provided from a migrated nons file referring to studies which are more than 12 years old, with the permission of ECHA.
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 acute effects 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.
