Registration Dossier
Registration Dossier
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EC number: 241-300-3 | CAS number: 17265-14-4
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Sebacic acid
- EC Number:
- 203-845-5
- EC Name:
- Sebacic acid
- Cas Number:
- 111-20-6
- Molecular formula:
- C10H18O4
- IUPAC Name:
- sebacic acid
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Italia S.p.A.
- Age at study initiation: not more than three months
- Weight at study initiation: ♂ 290 - 350 g; ♀ 247-286 g
- Housing: 5 animal per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±2
- Humidity (%): 55 ±10
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 6x5 cm
- % coverage: 10 %
- Type of wrap if used: hypoallergenic non-irritaing tape
REMOVAL OF TEST SUBSTANCE
- Washing: yes, with water
- Time after start of exposure: 24 h - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 30 min, 2, 4, and 6 hours an the first day after the administration, twice a day up to termination
- Other examinations performed: clinical signs, body weight, histopathology, gross pathology
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:
- No mortality occurred.
- Clinical signs:
- other: No general or local clinical abnormalities were seen in any animal.
- Gross pathology:
- No apprecible changes were evident in the treated animals of either sex at the autopsy carried out at the end of the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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