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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 224-030-0 | CAS number: 4170-30-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Positive in Ames Assay with and without metabolic activation using the preincubation method with Salmonella Strains TA 100 and TA 104; negative with and without metabolic activation in the plate incorporation method in all strains. Plate incorporation method was not suitable to demonstrate the mutagenic effect in bacteria. Testing results were positive for sister chromatid exchange induction in Chinese Hamster ovary cells and in micronucleus assay. Results from chromosome aberration testing (Dittberner, 1995) demonstrated that there were no numerical aberrations or increase in centromere positive micronuclei, indicating a non-aneugenic effect. Negative in other assays (UDS, HGPRT).
In vivo genotoxicity: Negative in a sex linked recessive lethal mutation assay upon oral administration but positive upon iv administration. Negative in two well conducted mouse micronucleus tests via repeated dose oral gavage but positive in a mouse micornucleus test with IP administration. Negative in an assay to detect specific crotonaldedhye induced DNA adducts upon oral gavage in rats. IP administration also resulted in spermatocyte chromosome aberrations at the highest dose tested (32 ul/kg bw) in mice and a decrease in viability in the dominant lethal study in mice. Studies by Moutschen-Dahmen reported germ cell mutagenicity but the data is unrealiable.
Based on the currently available data, crotonaldehyde is genotoxic and forms adducts in vitro, however in vivo mutagenicity seems to be less clear. Positive results were seen in vivo after intraperitoneal and IV administration but negative results were reported after oral administration. For the available data, crotonaldehdye is genotoxic in vivo at non-physiologically relevant routes of entry.
Short description of key information:
Positive for bacterial mutagenicity; positive for chromosome aberrations (in vitro Sister Chromatid Exchange (SCE) assay; positive in vitro micronucleus test) and negative in an in vitro mammalian mutagenicity study (HPRT). Positive for DNA aduct formation. Negative for Unscheduled DNA repair.
Endpoint Conclusion: Adverse effect observed (positive)
Justification for classification or non-classification
According to criteria in regulation (EC) No. 1272/2008, the substance is classified as category 2 mutagen.
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.
