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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 253-211-7 | CAS number: 36788-39-3
Neurotoxicity
Administrative data
Description of key information
Guideline OECD 422 oral study in rats
Key value for chemical safety assessment
Effect on neurotoxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
The test item was administered by gavage to three groups, each of twelve male and twelve female Wistar Han™:RccHan™:WIST strain rats, for approximately six weeks (including a two week pre-pairing phase, pairing, gestation and early lactation for females), at dose levels of 100, 300 and 1000 mg/kg bw/day. A control group of twelve males and twelve females was dosed with vehicle alone (Polyethylene glycol 400) over the same treatment period and at the same dosage volume. The study is not a neurotoxicity study in itself but laboratory investigations including behavioural assessments, functional performance tests and sensory reactivity assessements were examined as part of the study.
At 1000 mg/kg bw/day, overall motor activity was statistically significantly lower than control for both sexes. There were no treatment-related changes in the behavioural parameters for either sex at 100, 300 or 1000 mg/kg bw/day. No inter-group differences in sensory reactivity assessments were apparent for either sex.
Justification for classification or non-classification
Under the conditions of the OECD 422 oral study, overall motor activity was statistically significantly lower than control for both sexes at a dose of 1000 mg/kg bw/day. There were no treatment-related changes in the behavioural parameters for either sex at 100, 300 or 1000 mg/kg bw/day. No inter-group differences in sensory reactivity assessments were apparent for either sex. The NOAEL for neurotoxicity is therefore considered to be 300 mg/kg bw/day. Based on these results, the test item does not warrant classification according to the criteria described in Regulation (EC) 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.
