Registration Dossier
Registration Dossier
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EC number: 811-213-0 | CAS number: 66711-86-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In Vitro (Mutagenic effects - bacterial): OECD 471; Bacterial reverse mutation assay. Negative. Reliability = 1.
In Vitro (Clastogenic effects - mammalian): OECD 473; Chromosome aberrations in human lymphocytes. Negative. Reliability = 1
In Vitro (Mutagenic effects - mammalian): OECD 476; In Vitro Mammalian Cell Gene Mutation. Negative. Reliability = 1
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
In Vivo (Clastogenic effects - mammalian): OECD 474; in vivo mouse micronucleus study; Negative at concentrations up to 500 ppm. Reliability = 1.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The substance was negative in a battery of in vitro and in vivo studies.
In vitro: The substance exhibited no mutagenic responses in either the presence or absence of metabolic activation in bacterial cells (Salmonella typhimurium strains TA98, TA100, TA1535, and TA1537 and Escherichia coli strain WP-2 uvrA).
The substance was not clastogenic in either the presence or absence of metabolic activation in human peripheral blood lymphocytes (OECD 473).
The substance was negative for the induction of forward mutations at the hypoxanthine-guanine phosphoribosyl transferase (HPRT) locus (hprt) of Chinese hamster ovary (CHO) cells, in the presence and absence of an exogenous metabolic activation system (OECD 476).
In vivo: The substance was negative in a peripheral blood micronucleus test in rats following a 90-day inhalation exposure up to exposure concentrations of 7500 ppm (50322 mg/m3).
Based on the results of this battery of genetic toxicity studies, it is concluded that the substance is not genotoxic in mammalian systems.
Justification for selection of
genetic toxicity endpoint
Multiple OECD guideline, GLP studies have been identified as key for
this endpoint. In addition the study selected above an Ames assay and in
vitro chromosome aberration plus in vitro cell gene mutation assays are
pertinent to the hazard conclusion for this endpoint.
Justification for classification or non-classification
The substance was not mutagenic or clastogenic when evaluated in a variety of guideline in vitro and in vivo test designs conducted in accordance with GLP standards. The substance does not need to be classified for mutagenicity according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) 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.
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