Registration Dossier
Registration Dossier
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EC number: 292-449-6 | CAS number: 90622-47-2
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: Guideline study, non-GLP
Data source
Reference
- Reference Type:
- publication
- Title:
- No information
- Author:
- Cassidy, S.L., Clark, D.G.
- Year:
- 1 977
- Bibliographic source:
- Toxicology of alpha olefins: Acute toxicity, skin and eye irritancy and skin sensitizing potential of alpha olefin 103 PQ 11
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: challenge
- Deviations:
- no
- Principles of method if other than guideline:
- Magnusson and Kligman
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Alkenes, C10-13
- EC Number:
- 287-479-1
- EC Name:
- Alkenes, C10-13
- Cas Number:
- 85535-87-1
- IUPAC Name:
- undec-3-ene
- Details on test material:
- Blend of C10-14-Olefins (C10: 11%, C11: 30%, C12: 26%, C13: 24%, C14: 9%)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: P strain
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- Intradermal Induction conc.: 0.05%
Induction vehicle: corn oil
Topical Induction conc.: 1.5%
Induction vehicle: corn oil
Challenge conc.: 10%
Challenge vehicle: corn oil
Challengeopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- Intradermal Induction conc.: 0.05%
Induction vehicle: corn oil
Topical Induction conc.: 1.5%
Induction vehicle: corn oil
Challenge conc.: 10%
Challenge vehicle: corn oil
- No. of animals per dose:
- 10
- Challenge controls:
- per sex per dose: 10 in test group; 5 each in control group
- Positive control substance(s):
- not specified
Results and discussion
Any other information on results incl. tables
A preliminary screen was carried out using groups of 2 male and 2 female guinea pigs to determine the concentrations of test material to be used for intradermal induction, topical induction and topical challenge.
Induction was accomplished in 2 stages, intradermal injection and a topical application. Two rows of 3 injections were made: 2 of 0.1 ml Freund’s complete adjuvant (FCA), 2 of 0.1 ml test material in solvent (solvent), and 2 of 0.1 ml test material in 50:50 FCA/solvent. The injection sites were just within the boundary of a 4x4 cm shaved area.
One week after the intradermal injections the same area was clipped. A 4x4 cm patch of Whatman No. 3 filter paper was soaked in a solution of the test material, placed over the injection sites of the experimental animals and covered by overlapping plastic adhesive tape (Blendaderm). This was secured with elastic adhesive bandage (Poroplast). The dressing was left in place for 48 hours.
The challenge procedure was carried out 2 weeks after topical induction. Challenge was accomplished by topical application of the challenge solution of the test material to the flank of both test and control groups of animals. 3x3 cm area on the flank was clipped and shaved. A 2.5x2.5 cm patch of Whatman No. 3 filter paper was soaked in a solution of the test material, placed over the injection sites of the experimental animals and covered by overlapping plastic adhesive tape (Blendaderm). This was secured with elastic adhesive bandage (Poroplast). The dressing was left in place for 24 hours. Examination of the challenge site was immediately, 24 and 48
hours after removal of the dressing.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Number of animals with skin reaction at challenge: 0/10 Number of animals with skin reaction in control group at challenge: 0/10.
Result: Negative for sensitization
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