Registration Dossier
Registration Dossier
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EC number: 246-916-6 | CAS number: 25377-72-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 April to 25 May 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Hagnusson, B. & Kligman, A. M. (1969) The identification of contact allergens by animal assay. The guinea-pig maximization test. J. Invest. Dermat., 52 268-276.
(Scoring) OECD Guidelines for testing chemicals (1981) Published by OEDC, 2, rue Andre-Pascal, 75775 Paris, Cedex 16, France. - GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Local Lymph Node Assay (LLNA) method not introduced that the time of testing.
Information based on data from 2019 review of dossier
Test material
- Reference substance name:
- Pentene
- EC Number:
- 246-916-6
- EC Name:
- Pentene
- Cas Number:
- 25377-72-4
- Molecular formula:
- C5H10
- IUPAC Name:
- pent-1-ene
- Details on test material:
- - Name of test material (as cited in study report): Pentene-1, N-amylene (as CAS No. 109-67-1)
- Physical state: Colourless liquid.
- Analytical purity: 94.4%
- Lot/batch No.: ST83/065
- Expiration date of the lot/batch: 1 October 1983.
- Stability under test conditions: Tested using infra-red spectra. The substance is judged to have been stable for the duration of the study. (Stabilities of formulations of the test substance) The stabilities of formulations of the test substance in corn oil or corn oil: Freund's Complete Adjuvant (1:1 v/v) were assessed by a panel of qualified chemists. These formulations were stable for at least one working day (7.5 h).
- Storage condition of test material: In the dark at ambient temperature.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Intradermal induction: 0.05% (m/v) in corn oil
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Intradermal induction: 0.05% (m/v) in corn oil
Topical induction: 50% (m/v) in corn oil
Topical challenge: 25% (m/v) in corn oil
- No. of animals per dose:
- Range-finding (intradermal): 2 per sex per dose
Topical induction: 2 per sex per dose
Topical challenge:
(dose group) ten males and ten females
(control group) five males and five females
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% (m/v) in vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No positive reaction observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% (m/v) in vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No positive reaction observed
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- In the guinea-pig maximisation test of Magnusson and Kligman none of the 20 test animals showed positive responses at 24 or 48 hours after removal of the challenge patches. The test material therefore had no sensitising potential in guinea pigs.
- Executive summary:
In the guinea-pig maximisation test of Magnusson and Kligman none of the 20 test animals showed positive responses at 24 or 48 hours after removal of the challenge patches. The test material therefore had no sensitising potential in guinea pigs.
The test material does not meet the criteria for classification according to EU classification system (Council Directive 67/548/EEC and Regulation (EC) No 1272/2008).
The test was conducted following to the similar methodologies as OECD testguideline 406 (1981). There are no information available regarding the testing facility therefore a reliability of 2 is assigned.
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