Registration Dossier
Registration Dossier
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EC number: 690-526-2 | CAS number: 38632-47-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Based on the results of the developmental toxicity study the substance will be labeled with “Repr. Cat. 1b” according to GHS. Consequently, no further testing is warranted to investigate fertility.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Based on the results of the developmental toxicity study the substance will be labeled with “Repr. Cat. 1b” according to GHS. Consequently, no further testing is warranted to investigate fertility.
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Based on the results of the developmental toxicity study the substance will be labeled with “Repr. Cat. 1b” according to GHS. Consequently, no further testing is warranted to investigate fertility.
Additional information
Based on the results of the developmental toxicity study the substance will be labeled with “Repr. Cat. 1b” according to GHS. Consequently, no further testing is warranted to investigate fertility.
Short description of key information:
Based on the results of the developmental toxicity study the substance will be labeled with “Repr. Cat. 1b” according to GHS. Consequently, no further testing is warranted to investigate fertility.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 232 mg/kg bw/day
- Species:
- rat
- Quality of whole database:
- Guideline developmental toxicity study according to OECD 414 and GLP.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The NOAEL (No-Observed-Adverse-Effect-Level) for maternal effects was 250 mg/kg body weight/day based on reduced body weight, body weight gains and food consumption in the 1000 mg/kg body weight/ day dose group.
Based on the increased incidence of fetal abnormalities found during visceral and skeletal examinations in the 1000 mg/kg body weight/ day dose group, the NOAEL for prenatal morphological alterations including teratogenicity was considered to be the mid dose, 250 mg/kg body weight/day (achieved dose level 231.7 mg/kg body weight/ day).
Justification for classification or non-classification
Based on the data of the delelopmental toxicity the compound will be classified with Repr. cat 2, R61 according to the EU classification criteria 67/548/EWG and Repr. 1b (H360) according to regulation no. 1272/2008 (GHS).
According to the ECHA guidance on the application of the CLP criteria, Version 3, dated November 2012 the compound will be allocated to the medium potency group (ED10 between 4 and 400 mg/kg/day) and, consequently, the "General Concentration Limits" according to regulation 1272/2008 (GHS) apply for this compound.
Additional information
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.
