Registration Dossier
Registration Dossier
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EC number: 262-967-7 | CAS number: 61788-32-7
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: In compliance with 21 CFR Part 58, available as unpublished report, no restrictions, adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 2009
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:
- Terphenyl, hydrogenated
- EC Number:
- 262-967-7
- EC Name:
- Terphenyl, hydrogenated
- Cas Number:
- 61788-32-7
- Molecular formula:
- C18Hn (n >18-36)
- IUPAC Name:
- Terphenyl, hydrogenated
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Isaac's farm
- Age at study initiation: Approximately 10 weeks
- Weight at study initiation: 2.25-2.86 kg
- Housing: One per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Shaved dorsal surface
- Type of wrap if used: latex rubber dantal dam
- Duration of exposure:
- 24 hours (continuous)
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 Males, 5 Females/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: three times during the first 8h and twice daily thereafter for a total of 14 days on test.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No deaths in either sex
- Gross pathology:
- No abnormalities were observed at gross necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- LD50 > 2.000 mg/kg
- Executive summary:
No deaths resulted from a dermal (24h occlusive) dosage of 2.000 mg/kg body weight of Terphenyl, hydrogenated to the shaved dorsal surface of of 5 male and 5 female New Zealand albino rabbits of both sexes. LD50 was therefore higher than 2.000 mg/kg body weight. No treatment-related abnormalities were noted in any groups.
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