Registration Dossier
Registration Dossier
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EC number: 419-480-1 | 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
2) Prival Test - salmonella
3) Mouse Micronucleus test.
Two separate bacterial reverse mutation tests showed that the substance does not have any mutagenic properties in different Salmonella strains. In addition, no genotoxic properties have been seen in the in vivo 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:
No genotoxic effects were observed in studies conducted
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
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 conducted to GLP an 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 prolonged 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.
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