Registration Dossier
Registration Dossier
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EC number: 203-005-8 | CAS number: 102-09-0
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)
- Version / remarks:
- modified according to the acute toxic class method
- GLP compliance:
- yes
- Remarks:
- Deviation from GLP: No analytical investigations on stability and homogeneity were perfomed.
- Test type:
- other: acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Diphenyl carbonate
- EC Number:
- 203-005-8
- EC Name:
- Diphenyl carbonate
- Cas Number:
- 102-09-0
- Molecular formula:
- C13H10O3
- IUPAC Name:
- diphenyl carbonate
- Details on test material:
- purity approx. 100 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: 8-12 weeks
- Weight at study initiation: mean 273 g for males and 216 g for females
- Fasting period before study: none
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- For a better contact to the skin, the test substance was moistened with water, applied to the prepared skin area and fixed with non-irritant skin plaster (occlusive conditions) for 24 hours.
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- Deviation from OECD 402: the number of animals and the procedure of dose finding was done according to OECD guideline 423 (Acute Oral Toxicity - Acute Toxic Class Method) due to animal welfare reasons.
- Statistics:
- none: limit test
Results and discussion
- Preliminary study:
- none
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- none
- Clinical signs:
- other: none
- Gross pathology:
- no noticable gross pathological findings
- Other findings:
- no local effects
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to EU criteria
- Conclusions:
- Under the conditions of this study, the acute dermal LD50 in rats was determined to be greater than 2000 mg/kg bw.
- Executive summary:
The acute dermal toxicity of the substance was investigated in accordance with the standardised guideline OECD 402 modified according to the acute toxic class method under GLP conditions.
During the study three male and three female Wistar rats were exposed to the test material moistened with water at a limit dose of 2000 mg/kg in an occlusive fashion for 24 hours.
Under the conditions of this study, the acute dermal LD50 in rats was determined to be greater than 2000 mg/kg bw.
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