Registration Dossier
Registration Dossier
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EC number: 238-851-7 | CAS number: 14782-75-3
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9 to 23 December 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 24 February 1987
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Aluminium ethyl acetoacetate neopentyl glycol complexes
- Cas Number:
- 569319-64-8
- Molecular formula:
- C11H19AlO5
- IUPAC Name:
- Aluminium ethyl acetoacetate neopentyl glycol complexes
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- The substance is the Source of the read-across.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Free access to mains drinking water and food was allowed throughout the study.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- arachis oil
- Details on dermal exposure:
- Test material, moistened with arachis oil, was applied evenly to an area of shorn skin (ca. 10% of body surface area). The area was covered with surgical gauze and self-adhesive bandage. The animals were caged individually for the 24 h exposure period. After 24 h, the bandage was removed and the treated skin and surrounding hair wiped with cotton wool moistened with arachis oil to remove residual test material.
- Duration of exposure:
- 24 h.
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 male and 5 female.
- Control animals:
- no
- Details on study design:
- Animals observed for death or overt signs of toxicity for 14 days.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- There were no deaths.
- Clinical signs:
- No signs of systemic toxicity.
- Body weight:
- All animals showed expected gains in bodyweight over the study period.
- Gross pathology:
- No abnormalities were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 (dermal, rat) > 2000 mg/kg.
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