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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 215-385-2 | CAS number: 1324-76-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In vitro
There were three in vitro gene mutation studies in bacteria (i.e. Salmonella typhimurium and Escherichia coli) was conducted in Experimental Toxicology and Ecology BASF, (Project No.: 40M0437/034091, 034092, 034093). Test article was applied at dose level up to 2500 µg/plate. 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 S-9 mix or after the addition of a metabolizing system. Based on the results of these studies, test article is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay.
In addition, one mouse lymphoma forward mutation assay(Dr. rer. nat. C. Flügge, report no. 28832) following OECD guideline 476 was conducted to assess the ability of the test item to induce forward mutations at the thymidine kinase (TK) locus in L5178Y TK +/- mouse lymphoma cells as assayed by colony growth in the presence of 5-trifluorothymidine (TFT).Based on the results of this study, test article in the absence and presence of metabolic activation in two independent experiments was negative with respect to the mutant frequency in the L5178Y TK +/- mammalian cell mutagenicity test. In addition, no change was noted in the ratio of small to large mutant colonies. Therefore, test article also did not exhibit clastogenic potential at the concentration-range investigated.
In vivo
An in vivo cytogenicity toxicity study( Dr. W. Müller, report no.: 94.0363) was performed to according to OECD guideline No. 474 with GLP to investigate the clastogenic potential of test article dosed once orally at level of 2000 mg/kg body weight to male and female mice. The animals were killed 12, 24, or 48 hours after administration. The ratio of polychromatic erythrocytes to normocytes was not changed to a significant extent by the treatment with test article and not different from the control values.
According to Chapter R.7a: Endpoint specific guidance, table R.7.7-5, row 9, no further tests are required since available data (negative results as above) is sufficient to conclude that test article is non-mutagenicy.
Short description of key information:
Based on the available information, test article can be considered non-mutagenicity.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on available data, test article can not be classified according to 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.
