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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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only short summary available. (analytical purity and composition of test substance not specified)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
lack of details on test substance, documentation insufficient
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Reference substance name:
Hexyl laurate
EC Number:
251-932-1
EC Name:
Hexyl laurate
Cas Number:
34316-64-8
IUPAC Name:
hexyl laurate
Details on test material:
- Name of test material (as cited in study report): [Trade name] (lauric hexylate)
- Physical state: oily liquid
- Analytical purity: no data

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: Treatment group: mean - 433 g (20 animals), control group: mean - 476 g (10 animals)

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: no data
Vehicle:
other: Vaseline
Concentration / amount:
1% in Vaseline
Challengeopen allclose all
Route:
other: epicutaneous
Vehicle:
other: Vaseline
Concentration / amount:
1% in Vaseline
No. of animals per dose:
Control group: 10 animals
Treatment group: 20 animals
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- no data

B. CHALLENGE EXPOSURE
- Exposure period: 24 hours
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1 %
Clinical observations:
percievable reddening, reversible within 24 hours
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 %. Clinical observations: percievable reddening, reversible within 24 hours.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1 %
Clinical observations:
percievable reddening, reversible within 24 hours
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1 %. Clinical observations: percievable reddening, reversible within 24 hours.

Any other information on results incl. tables

No individual data given. However, the experimental and control animals reacted to the retreatment qualitatively identical with percievable reddening of the parts of the skin treated, this quickly subsided and 24 hours after removal of the patch no further reaction was visible. The same observations are by experience made where vaseline is used as the medium for retreatment.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified

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