Registration Dossier
Registration Dossier
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EC number: 252-091-3 | CAS number: 34562-31-7
Acute Toxicity: oral
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: U.S. 52 FR 42961, 49 CFR 173.132
- Principles of method if other than guideline:
- This study was performed under the DOT guidelines specified in 52 FR 42961, 49 CFR 173.132
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Test material form:
- liquid
- Details on test material:
- Yellowish Brown Liquid, Lot # 00312AB, no purity given
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Albino rats, five males and five females
All weighed between 200 and 300g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- All rats were administered a single Sponsor specified dose of the test substance by oral gavage.
- Doses:
- 500 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- All animals received a single dose of 500 mg/kg bw of the test substance by oral gavage. The dose volume did not exceed 1 ml/100 g body weight. Following treatment, the animals were observed for clinical signs of toxicity at least once daily for 14 days. Body weights were determined on Day 0, Day 7, and Day 14.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 1 rat died on Day 2 of the observation period.
- Clinical signs:
- other: Two of the test animals exhibited clinical signs
- Gross pathology:
- The animal that died during the study was observed at necropsy as having a moderately pale liver. All other animals were observed as having no visible lesions at necropsy
Any other information on results incl. tables
The oral LD50 of the test material is ≥500 mg/kg bw according to a U.S. DOT guideline study.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- > 300 mg/kg as per Regulation EC No. 1272/2008
- Conclusions:
- The oral LD50 of the test material is greater than 500 mg/kg bw in rats.
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.
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