Registration Dossier
Registration Dossier
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EC number: 205-487-5 | CAS number: 141-52-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: acceptable study, meets basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
Materials and methods
- Principles of method if other than guideline:
- Guinea pig maximization test acc. Magnusson and Kligman (1969) J. Invest. Derm. , 52, 269
- GLP compliance:
- yes
- Remarks:
- BP Group Occupational Health Centre
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Ethanol
- EC Number:
- 200-578-6
- EC Name:
- Ethanol
- Cas Number:
- 64-17-5
- Molecular formula:
- C2H6O
- IUPAC Name:
- ethanol
- Details on test material:
- test substance: ethanol
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Subst. 1: intradermal : 25%, topical : 37.5%; challenge: 1st and 2nd challenges : 25%, 47.5%;
Subst. 2: intradermal and topical: 37.5%, challenge: 1st a challenge: 37.5%, 60% and 71.25%; 2nd challenge : 22.5%, 60% and 71.25%
Challengeopen allclose all
- Route:
- other: epicutanous, unspecified
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Subst. 1: intradermal : 25%, topical : 37.5%; challenge: 1st and 2nd challenges : 25%, 47.5%;
Subst. 2: intradermal and topical: 37.5%, challenge: 1st a challenge: 37.5%, 60% and 71.25%; 2nd challenge : 22.5%, 60% and 71.25%
- No. of animals per dose:
- 10
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no data.
Any other information on results incl. tables
No skin reactions were evoked at challenge with the polyalkalene glycol in 75% ethanol in either test or control group animals. Although this study was not primarily carried out to assess polyalkalene glycol, it can be reliably concluded that ethanol did not show any signs of sensitizing properties.
Applicant's summary and conclusion
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