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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 259-583-7 | CAS number: 55302-96-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Gene mutation test in bacteria (Bacterial reverse mutation assay / Ames test): negative with and without metabolic activation for all S. typhimurium tested strains (TA 1535, TA 1537, TA98, TA100 and TA 102) (OECD Guideline 471, GLP, Klimisch 1).
Cytogenicity / Micronucleus test in vitro: positive without metabolic activation and a treatment for 20 h (Draft version of the OECD Guideline 487, GLP, Klimisch 1).
Mutagenicity in mammalian cells: 1) positive without metabolic activation after the 3h treatment in L5178Y mouse lymphoma cells (TK+/-) (OECD Guideline 476, GLP, Klimisch 1), 2) negative with and without metabolic activation in L5178Y mouse lymphoma cells (HPRT) (OECD Guideline 476, GLP, Klimisch 2)
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Genetic toxicity in vivo
Description of key information
Cytogenicity / erythrocyte micronucleus in vivo: negative in an in vivo rat micronucleus assay by the oral route (OECD Guideline 474, GLP, Klimisch 1)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Four reliable guideline or similar to guideline in vitro genotoxicity studies (Bacterial reverse mutation assay :OECD Guideline 471, GLP, Klimisch 1; Micronucleus test in vitro: Draft version of the OECD Guideline 487, GLP, Klimisch 1; Mutagenicity in mammalian cells-MLA test (TK locus): OECD Guideline 476, GLP, Klimisch 1; Mutagenicity in mammalian cells-MLA test (HPRT): OECD Guideline 476, GLP, Klimisch 1), and one reliable guideline in vivo genotoxicity study (Micronucleus test in vivo: OECD Guideline 474, GLP, Klimisch 1) with 2-Methyl-5-hydroxyethylaminophenol are available for the Genetic toxicity endpoint.
The results of these studies showed that 2-Methyl-5-hydroxyethylaminophenol is mutagenic in vitro. It induced gene mutations in cultured mammalian cells (TK locus). It also induced micronuclei in mammalian cells in vitro (the substance was not mutagenic in the Bacterial reverse mutation and in the HPRT Mutagenicity in mammalian cells tests). The test substance did not induce damage to chromosomes or the mitotic apparatus in the in vivo micronucleus test. Thus, the mutagenic potential of 2-Methyl-5-hydroxyethylaminophenol seen in vitro does not lead to genotoxic or mutagenic effects in vivo under appropriate test conditions. The results of plasma analysis suggested systemic availability, but no clear evidence of bone marrow exposure was demonstrated. There is, however, no evidence that the bone marrow was exposed.
Justification for classification or non-classification
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.
