Registration Dossier
Registration Dossier
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EC number: 262-774-8 | CAS number: 61417-49-0
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-1 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Doses:
- 1, 2, 4, 8, 16, 24, 30 g/kg bw
- No. of animals per sex per dose:
- 5
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 30 000 mg/kg bw
- Based on:
- test mat.
- Gross pathology:
- No remarkable effects observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No signs of gross toxicity and patholgy at dose of 30 g/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 30 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Acute oral toxicity to rat was conducted for the target substance and the LD50 was found to be greater than 30 g/kg bw. Mortality was observed at lower dose but was regarded as not dose-related.
The hydrolysis product isostearic acid has LD50 (rat) greater than 32ml/kg (appox. 28.8 g/kg) (CIR, 1983) and is therefore non-toxic.
TiO2 was considered non-hazardous, based on the published data on EHCA C&L database. The lowest dose reported to produce any toxic effect in rats by oral route is determined to be 60 g/kg (US EPA, 1994).
Based on above findings, the target substance is considered not acute toxic and there is no need to classify the substance as acute oral toxic.
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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