Registration Dossier
Registration Dossier
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EC number: 929-305-5 | 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Performed to recognised methods 2014
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Principles of method if other than guideline:
- Sighting study performed with 300 mg/kg and 2000 mg/kg
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- Sighting study of 300 and 2000 mg/kg; no effects
Main study 2000 mg/kg - No. of animals per sex per dose:
- 1 Female at 300 mg/kg sighting study
1 Female at 2000 mg/kg in sighting study
4 further females at 2000 mg/kg in study - Control animals:
- no
- Sex:
- female
- Dose descriptor:
- discriminating dose
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: None
- Gross pathology:
- None
- Other findings:
- None
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The discriminating dose was considered > 2000 mg/kg
- Executive summary:
No adverse effects at 2000 mg/kg.
Note that this animal test was initially performed to meet non-EU regulatory demands.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
Only one study performed. Considered reliable.
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.
