Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 259-766-1 | CAS number: 55699-10-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The substance was tested for its mutagenic potential in an OECD 471 guideline study (compliant with GLP) based on the ability to induce point mutation in selected loci of several bacterial strains, i.e. Salmonella typhimurium (TA 1535, TA 100, TA 1537, TA98) and Escherichia coli (WP2 uvrA) in a reverse mutation assay (BASF 2008). A standard plate test (SPT) and a preincubation test (PIT) both with and without metabolic activation (Aroclor-induced rat liver S9 mix) were used. Bacteria were exposed to 20 - 5 000 μg/plate (SPT; all strains), 125 - 2000 μg/plate (PIT; TA 1535, E. coli), 31.3 - 500 μg/plate (PIT; TA 100, TA 98), 62.5 - 1000 μg/plate (PIT; TA 1537). Precipitation of the test substance was found from about 2000 μg/plate onward with and without S9 mix. A bacteriotoxic effect was observed depending on the strain and test conditions from about 250 - 500 μg/plate onward. An increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system. It was therefore concluded that the test substance is not mutagenic under these experimental conditions.
Justification for selection of genetic toxicity endpoint
One genetic toxicity in vitro study is available. This study is adequate for covering this endpoint.
Short description of key information:
The test substance is not a mutagenic substance in a bacterial reverse mutation test (OECD 471, GLP) in the absence and the presence of metabolic activation.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
4-tert-butyl-3-hydroxy-2,6-xylylacetonitrile was not mutagenic in the performed Ames test. Based on this classification for genetic toxicity is not warranted in accordance with EU Directive 67/548 (DSD) and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.
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.
