Registration Dossier
Registration Dossier
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EC number: 252-346-9 | CAS number: 35074-77-2
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Dec. 1969 - Jan. 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP study. Scientifically acceptable report with few methodological defiencies. Only two dose levels with 4 animals each were tested.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 970
- Report date:
- 1970
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- Only two dose levels were tested. Only 4 animals were used at each dose level. Half of the animals were abraded.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Hexamethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
- EC Number:
- 252-346-9
- EC Name:
- Hexamethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
- Cas Number:
- 35074-77-2
- Molecular formula:
- C40H62O6
- IUPAC Name:
- 6-{[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoyl]oxy}hexyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate
- Details on test material:
- - Physical state: solid
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: in house breed
- Weight at study initiation: 2 - 3 kg
- Housing: individually
- Diet: ad libitum, Altromin K (ALTROMIN GmbH, Lage/Lippe))
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2
- Humidity (%): 60±3
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- not specified
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back was shaved and half of the animals were abraded.
- Type of wrap if used: rubber sleeve
TEST MATERIAL
- Concentration: 50% suspension - Duration of exposure:
- Refer to observation period. Skin sites were not washed after 24 hours with the semiocclusive dressing.
- Doses:
- 2500, 10000 mg/kg bw
- No. of animals per sex per dose:
- 4
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations and weekly weighings
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: No clinical signs were observed.
- Gross pathology:
- No gross internal lesions were observed during necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
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