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EC number: 204-260-8 | CAS number: 118-56-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: pre OECD and pre-GLP study with limited documentation but fulfilling basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Homosalate
- EC Number:
- 204-260-8
- EC Name:
- Homosalate
- Cas Number:
- 118-56-9
- Molecular formula:
- C16H22O3
- IUPAC Name:
- 3,3,5-trimethylcyclohexyl salicylate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 5000 mg/kg bw applied
- No. of animals per sex per dose:
- 10 animals
- Control animals:
- no
- Statistics:
- not required
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no deaths occured
- Clinical signs:
- other: No clinical signs were observed.
- Gross pathology:
- Necropsy revealed 6/10 animals were normal; brown anogenital exudate in 1/10 animals; red areas in the intestines in 1/10 animals; bloated intestines in 1/10 animals; dark liver in 2/10 animals; white nodules in the liver in 2/10 animals.
- Other findings:
- Skin redness slight in 4/10 and moderate in 6/10 animals
Skin edema slight in 7/10 and moderate in 3/10 animals
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 (dermal., rabbit): > 5000 mg/kg bw
- Executive summary:
In this study 10 rabbits per dose were used (only one dose applied being 5000 mg/kg and therefore no further doses were applied). Animals were observed for mortality and/or systemic effects. Gross necropsy was performed on all animals.
All rabbits survived the study until end and thus the LD50 was found being > 5000 mg/kg. No further doses were consequently applied and the study may be considered as limit test accordingly.
No clinical sign observed. Necropsy revealed 6/10 animals were normal; brown anogenital exudate in 1/10 animals; red areas in the intestines in 1/10 animals; bloated intestines in 1/10 animals; dark liver in 2/10 animals; white nodules in the liver in 2/10 animals.
Slight skin redness was observed in 4 and moderate redness in 6 animals whereas in 7 animals slight edema were noted and moderate edemas in thee remainder.
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