Registration Dossier
Registration Dossier
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EC number: 200-064-1 | CAS number: 50-78-2
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: Before BPL and guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Principles of method if other than guideline:
- ASA: in an isotonic phosphate buffer at pH7. The volume injected in each case was 0.1 ml. The 5 injections were administered on Days 0, 2, 5, 8 and 12.On Day 16, the contact solution was applied. Each time, we used a mixture of acetone-almond oil in a 1:1 ratio (V:V).
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- O-acetylsalicylic acid
- EC Number:
- 200-064-1
- EC Name:
- O-acetylsalicylic acid
- Cas Number:
- 50-78-2
- Molecular formula:
- C9H8O4
- IUPAC Name:
- 2-acetoxybenzoic acid
- Test material form:
- solid: crystalline
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Concentration / amount:
- 200 and 100 mg/ml
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Concentration / amount:
- 200 and 100 mg/ml
- No. of animals per dose:
- 10
- Positive control substance(s):
- yes
- Remarks:
- acetylsalicylic acid anhydride (ASAN)
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 200 mg/mL
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 200 mg/mL. No with. + reactions: 0.0. Total no. in groups: 0.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- ASA is not sensitizing in a guinea pig test comparable to maximisation.
- Executive summary:
ASA tested at high doses ( induction at 200 and 100 mg/ml intracutaneous) in guinea pigs, with a normal amount ( 0.01%) od the sensitising impurity ASAN, was totally negative in ths assay.
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