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Toxicological information

Skin sensitisation

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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:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Tradename Kalcol 8098

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).