Registration Dossier
Registration Dossier
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EC number: 205-011-6 | CAS number: 131-11-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Patch-test Reactions to Plastic and Glue Allergens
- Author:
- Kanerva L et al.
- Year:
- 1 999
- Bibliographic source:
- Acta Derm Venerol, 79: 296-300
Materials and methods
- Principles of method if other than guideline:
- Patch-testing was performed with 2 days' occlusion and 3 readings (usually on days 2, 3 and 4 - 6). Allergic reactions were scored according to ICDRG recommendations. 1+ (palpable erythema, papules), 2+ (oedematous, vesicles) and 3 + (bullous) reactions were considered allergic. Irritant reactions were also
recorded. Reactions scored as doubtful (?+) or irritant (IR) were classifed as irritant. - GLP compliance:
- not specified
- Type of study:
- patch test
Test material
- Reference substance name:
- Dimethyl phthalate
- EC Number:
- 205-011-6
- EC Name:
- Dimethyl phthalate
- Cas Number:
- 131-11-3
- Molecular formula:
- C10H10O4
- IUPAC Name:
- 1,2-dimethyl benzene-1,2-dicarboxylate
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 5 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 5 %
Results and discussion
Any other information on results incl. tables
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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