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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 303-085-5 | CAS number: 94158-14-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Justification for classification or non-classification
A set ofin vitroandin vivostate of the art mutagenicity tests withHYDROXYETHYL-3,4-METHYLENEDIOXYANILINE HCLof defined quality was performed which covers all scientifically relevant endpoints.HYDROXYETHYL-3,4-METHYLENEDIOXYANILINE HCLdid not show any potential to cause gene mutations in bacterial or mammalian cellsin vitro, as both theand the mouse lymphoma assay were negative. Clastogenic effects were observed in a micronucleus test in human lymphocytes in the presence of S9 mix, but not in the mouse lymphoma assay. The observed increase in micronucleated lymphocytes in the micronucleus test was, however, limited to cytotoxic doses.
To clarify this finding, a micronucleus testin vivowas performed. In this study,HYDROXYETHYL-3,4-METHYLENEDIOXYANILINE HCL,administered via the intraperitoneal route, did not cause clastogenic or aneugenic effects at doses up to the maximum tolerated dose of 250 mg/kg bw. For intraperitoneal administration 100% bioavailability of the test compound can be assumed.
Taken together, the available test results clearly support the absence of a genotoxic hazard underin vivoconditions. Therefore,HYDROXYETHYL-3,4-METHYLENEDIOXYANILINE HCLis considered not to pose any risk to humans with regard to mutagenicity/genotoxicity.
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.
