Registration Dossier
Registration Dossier
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EC number: 246-644-8 | CAS number: 25134-21-8
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)
- Rationale for reliability incl. deficiencies:
- other: Experimental data from a human repeat insult patch test. Detailed information on methods and results not available
Data source
Reference
- Reference Type:
- grey literature
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Human Repeat Insult Patch Test
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- Study undertaken prior to the introduction of the LLNA (OECD TG 429 originally adopted April 2002)
Test material
- Reference substance name:
- 1,2,3,6-tetrahydromethyl-3,6-methanophthalic anhydride
- EC Number:
- 246-644-8
- EC Name:
- 1,2,3,6-tetrahydromethyl-3,6-methanophthalic anhydride
- Cas Number:
- 25134-21-8
- Molecular formula:
- C10H10O3
- IUPAC Name:
- 3a,4,7,7a-tetrahydromethyl-4,7-methano-2-benzofuran-1,3-dione
- Test material form:
- not specified
- Details on test material:
- No data
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- no data
- Concentration / amount:
- no data
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- no data
- Concentration / amount:
- no data
- No. of animals per dose:
- 53 subjects
- Details on study design:
- No data
- Challenge controls:
- No data
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No data
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- other: No data
- Group:
- test chemical
- Dose level:
- No data
- No. with + reactions:
- 34
- Total no. in group:
- 53
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- other: n/a
- Group:
- negative control
- Dose level:
- n/a
- Remarks on result:
- not measured/tested
- Remarks:
- Human repeat insult patch test - No negative control group
- Reading:
- other: n/a
- Group:
- positive control
- Dose level:
- n/a
- Remarks on result:
- not measured/tested
- Remarks:
- Human repeat insult patch tests - No positive control
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The substance is a skin sensitiser
- Executive summary:
Skin sensitisation has been investigated in a human repeat insult patch test. A total of 34 of 53 subjects showed skin reaction during induction and challenge
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