Registration Dossier
Registration Dossier
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EC number: 947-760-8 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Justification for type of information:
- Study conducted outside the EU over 10 years before the EU cosmetic testing ban came into effect.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations 16, Part 1500.3 (USA)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- fixed dose procedure
Test material
- Reference substance name:
- 2-ethylhexyl 12-hydroxyoctadecanoate
- EC Number:
- 249-793-7
- EC Name:
- 2-ethylhexyl 12-hydroxyoctadecanoate
- Cas Number:
- 29710-25-6
- Molecular formula:
- C26H52O3
- IUPAC Name:
- 2-ethylhexyl 12-hydroxyoctadecanoate
- Test material form:
- other: oil
- Details on test material:
- a-ethyl-hexyl-oxystearate
Constituent 1
- Specific details on test material used for the study:
- a-ethyl-hexyloxystearate
colourless liquid
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Not detailed
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Observed for 2 weeks post-dose
- Doses:
- Single gavage at 8ml/kg
- No. of animals per sex per dose:
- 10
- Control animals:
- no
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 8 mL/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 8 mL/kg bw
- Based on:
- test mat.
- Mortality:
- 2 animal died during the study period.
- Clinical signs:
- other: Not reported.
- Gross pathology:
- Not reported.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 20% of the animals used at the dose level of 8ml/kg died. LD50 is greater than 8ml/kg
- Executive summary:
In this guideline (CFR 1500.3) study the LD0 of the test material was determined to be 8 ml/kg bw. 5 male and 5 female rats were dosed orally by gavage at 8 mL/kg and observed for 2 weeks post-dose. 2 deaths were observed.
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