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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 209-527-2 | CAS number: 584-03-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Route of administration:
- oral: unspecified
- Vehicle:
- other: Distilled water
- Remarks:
- Doses / Concentrations:
40-1000 mg/kg BW
Basis:
no data - No. of animals per sex per dose:
- Male 10/Dose (10 controls)
Female 10/Dose (10 controls) - Control animals:
- yes
- Details on study design:
- Daily oral gavage of 0 (negative control), 40, 200, or 1000mg/kg body weight/day for 42 days for males. Females were exposed from day 14 before
mating to day 3 of lactation. - Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day
- Based on:
- not specified
- Sex:
- male
- Remarks on result:
- other: Generation not specified (migrated information)
- Dose descriptor:
- other: EDLC
- Effect level:
- 0.2 other: mg/kg/day
- Sex:
- male
- Remarks on result:
- other: Generation not specified (migrated information)
- Reproductive effects observed:
- not specified
Reference
NOAEL: 200mg/kg body weight/day was the dose at which no toxic effects were observed.
EDLC: 0.2mg/kg/day was calculated as estimated dose of low concern for repeated dose toxicity.
There were no death throughout the observation period of 42 days. Body weight, food consumption, hematology parameters, clinical chemistry parameters, organ weight, or pathological examination between the treated and control animals did not show any visible differences.
Transient hypolocomotion and hypopnea at the 1000mg/kg in females.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 200 mg/kg bw/day
- Study duration:
- subchronic
Additional information
Neither effects on reproduction (copulation, implantation, pregnancy, parturition, or lactation) nor developmental toxicity effects on offspring were observed.
Justification for classification or non-classification
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.
