Registration Dossier
Registration Dossier
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EC number: 412-830-4 | CAS number: 1823-59-2 ODPA
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The skin sensitisation in-vivo (non-LLNA) experimental study reported in this section should be considered as acceptable since it was performed before the LLNA skin sensitisation method was considered to be the preferred one for new in-vivo testings.
Moreover and according to ECHA guidance R.7a, page 234, existing data of good quality derived from tests such as the Buehler test are acceptable and, if they provide clear results, will preclude the need for further in vivo testing.
Test material
- Reference substance name:
- 4,4'-oxydiphthalic anhydride
- EC Number:
- 412-830-4
- EC Name:
- 4,4'-oxydiphthalic anhydride
- Cas Number:
- 1823-59-2
- Molecular formula:
- C16H6O7
- IUPAC Name:
- 5-[(1,3-dioxo-1,3-dihydro-2-benzofuran-5-yl)oxy]-1,3-dihydro-2-benzofuran-1,3-dione
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Adequacy of induction:
- other: Information on adequacy of induction not available
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Adequacy of challenge:
- other: Information on adequacy of challenge not available
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 10 - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 50%
Signs of irritation during induction:
Signs of irritation during induction were not scored during this test.
Evidence of sensitisation of each challenge concentration: None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not classified.
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