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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 940-308-0 | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
Absorption, Distribution, Metabolism and Excretion of the substance have been assessed on the basis of the available experimental studies results.
Toxicity
Acute oral and dermal toxicity studies in rats: in the limit test at a fixed dose of 2000 mg/kg no significant treatment related effects were seen. In these studies LD50 was higher than 2000 mg/kg.
In the 28 -day toxicity combined with reproductive endpoint study in rats, the repeated administration by oral route showed some adverse systemic effects. NOAEL was considered to be lower than 100 mg/kg/day for males and females.
The presence of general effects does lead to conclude that the test item is adsorbed and distributed systemically.
For reproductive end-points the effects were seen at 750 mg/kg/day.NOAEL for reproduction is therefore set at 300 mg/kg/day.
No information are available concerning excretion rates.
Mutagenicity
The test substance was not mutagenic in the bacterial mutation assay and in the "in vitro" chromosome aberration study using CHO V79 cells, with and without metabolic activation system as well as in the mouse lymphoma test (MLA). These studies also demonstrated that no difference of behaviour has been showed after metabolic activation of the substance with S9 mix. Toxicity is therefore not induced or enhanced by the metabolism of the substance.
Assessment
The effects seen do suggest a possible absorption by GI tract at given doses.
The bioaccumulation evaluation suggests that the test substance will not bioaccumulate in aquatic organisms and no secondary poisoning through the food chain may be realistic.
No skin absorption was observed when applied during the acute dermal toxicity study as no systemic effect were observed.
In the 28 -day toxicity combined with reproductive endpoint study in rats, the repeated administration by oral route showed some adverse systemic effects: the test substance is therefore considered to be absorbed systemically and hence could show toxic potential.
Conclusion
The results of the toxicity studies by gavage showed that the test substance was absorbed and distributed systemically; absorption leads to some toxic effect.
Excretion in urine is deemed to be realistic as the substance is absorbed systematically.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.
