Registration Dossier
Registration Dossier
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EC number: 203-005-8 | CAS number: 102-09-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- 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:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- 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: 99.95 %, Phenol 0.05 %
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: adjacent area of untreated skin on each animal served as the control
- Amount / concentration applied:
- Concentration: 100 %
Test substance was ground to a fine powder and a dose of 0.5g was applied to each application site - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 30-60 min, 24h, 48h, and 72h after the 4 hour exposure period
- Number of animals:
- 6 females
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24, 48, and 72h
- Score:
- 0
- Max. score:
- 8
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- none
- Other effects:
- none
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating according to EU criteria
- Conclusions:
- Under the conditions of this study, diphenyl carbonate is considered to be a non-irritant.
- Executive summary:
The skin irritation potential of the substance was investigated in a study which was conducted in accordance with the standardised guideline OECD 404 under GLP conditions.
During the study six (female) New Zealand White rabbits were dosed with 0.5 g of the test material in a semi-occlusive fashion for four hours. Observations were made at 30 to 60 minutes, 24, 48 and 72 hours after the end of the contact period. No erythema/oedema was observed for any animal at any time period.
Under the conditions of this study, diphenyl carbonate is considered to be a non-irritant.
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