Registration Dossier
Registration Dossier
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EC number: 947-930-1 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-05-05 to 2003-05-27
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- 5 female rats, 9-10 weeks old (160-192g) at experimental start. Housed singly. Temperature range 20-24C with 12/12 hour light/dark cycle.
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Animals were fasted overnight night prior to receiving a single oral dose of test substance at 2,000 mg/kg bw. Feed was replaced approximately 3-4 hours after dosing.
- Doses:
- single oral dose at 2,000 mg/kg bw
- No. of animals per sex per dose:
- 5 female
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: None observed
- Gross pathology:
- unremarkable
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Under the conditions of this study the test substance has an acute oral LD50 of > 2,000 mg/kg bw in female rats.
- Executive summary:
5 female rats were fasted overnight night prior to receiving a single oral dose of test substance at 2,000 mg/kg bw. Feed was replaced approximately 3-4 hours after dosing. All animals survived and gained bodywieght. No signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour were observed. Under the conditions of this study the test substance has an acute oral LD50 of > 2,000 mg/kg bw in female rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Justification for classification or non-classification
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.
