Registration Dossier
Registration Dossier
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EC number: 942-135-6 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the appropriate EU guideline and in compliance with GLP. The study is read across from 1-octadecanol (CAS 112-92-5).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Octadecan-1-ol
- EC Number:
- 204-017-6
- EC Name:
- Octadecan-1-ol
- Cas Number:
- 112-92-5
- Molecular formula:
- C18H38O
- IUPAC Name:
- octadecan-1-ol
- Details on test material:
- Tradename Kalcol 8098
Constituent 1
In vivo test system
Test animals
- Species:
- other:
- Strain:
- Dunkin-Hartley
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: arachis oil
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: arachis oil
- No. of animals per dose:
- 10
- Details on study design:
- 1st application: Induction 1 % intracutaneous
2nd application: Induction 50 % occlusive epicutaneous
3rd application: Challenge occlusive epicutaneous
Results and discussion
Any other information on results incl. tables
RESULTS OF PILOT STUDY: Minimal erythema at 24 and 48 hours after 48 hour topical exposure, no irritation at these time periods after a 24 hour
topical application. Well defined erythema (grade 2) at 24, 48 and 72 hours post injection reducing to slight erythema (grade 1) at 7 days.
RESULTS OF TEST
- Sensitization reaction: No positive responses with 25% or 50% challenge concentrations in test or control groups at 24 or 48 hours. 0/10 treated and
0/5 controls responded to challenge.
- Clinical signs: Body weights and weight gain over the observation period were comparable in test and control groups. Well-defined erythema was
noted at the intradermal induction sites of all test group animals at 24 and 48hours. Very slight to well-defined erythema was noted at the
intradermal sites of the control group at 24 and very slight erythema at 3 sites at 48 hours.
Very slight to well-defined erythema was noted at the induction sites of six test group animals at the 1 hour mark. No skin reactions were noted at
the induction sites of any test group animals at the 24 hour mark.
- Rechallenge: Not carried out.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Kalcol 8098 is not a skin sensitiser when tested using the Magnusson and Kligman guinea pig maximization procedure.
The result is read across from 1-octadecanol (CAS 112-92-5).
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