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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate EU guideline and in compliance with GLP, on a related material.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
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

Constituent 1
Chemical structure
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:
- Name of test material (as cited in study report): Tradename Kalcol 8098
- Molecular formula (if other than submission substance): C18-H38-O
- Molecular weight (if other than submission substance): 270
- Smiles notation (if other than submission substance): C(CCCCCCCCC)CCCCCCCCO
- InChl (if other than submission substance): InChI=1/C18H38O/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-18-19/h19H,2-18H2,1H3
- Structural formula attached as image file (if other than submission substance): see Fig. 1

In vivo test system

Test animals

Species:
other:
Strain:
Dunkin-Hartley
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: arachis oil
Concentration / amount:
Intradermal induction: 1% w/v in arachis oil BP; Topical challenge - 50% w/w in arachis oil BP; Topical challenge - 50% and 25% w/w in arachis oil BP.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: arachis oil
Concentration / amount:
Intradermal induction: 1% w/v in arachis oil BP; Topical challenge - 50% w/w in arachis oil BP; Topical challenge - 50% and 25% w/w in arachis oil BP.
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 Criteria used for interpretation of results: EU
Conclusions:
Kalcol 8098 is not a skin sensitiser when tested using the Magnusson and Kligman guinea pig maximization procedure.

Classification: not sensitizing