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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study run to a method comparable with current guidelines, no GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Acceptable guinea pig maximisation test equivalent or simialr to OECD Guideline 406.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch No.: not specified
Purity: not specified

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
None stated

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Paraffin oil (Intradermal Induction) and petrolatum (Topical Induction and Challenge)
Concentration / amount:
Intradermal Induction: 3.0%
Topical Induction: 15.0%
Challenge: 7.0%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Paraffin oil (Intradermal Induction) and petrolatum (Topical Induction and Challenge)
Concentration / amount:
Intradermal Induction: 3.0%
Topical Induction: 15.0%
Challenge: 7.0%
No. of animals per dose:
10 animals per dose
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10 for Intradermal Induction and 10 for Topical Induction
- Exposure period: Intradermal Induction: 1 day; Topica1 Induction: 48 h, occluded
- Test groups: 10 animals per group for two groups
- Control group: yes
- Frequency of applications: once daily
- Concentrations: 3.0% (in paraffin oil) and 15.0% (in petrolatum)

B. CHALLENGE EXPOSURE
- No. of exposures: 20
- Exposure period: 24 h, occluded
- Test groups: 10 animals per group for two groups
- Control group: yes
- Concentrations: 7.0 (in petrolatum)

No additional data
Challenge controls:
None stated
Positive control substance(s):
yes
Remarks:
isoeugenol

Results and discussion

Positive control results:
The isoeugenol gave a 100% response to Guinea Pig.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
other: Challenge I
Hours after challenge:
48
Group:
test group
Dose level:
7.0% in petrolatum
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: Challange I. . Hours after challenge: 48.0. Group: test group. Dose level: 7.0% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
other: Challenge II
Hours after challenge:
48
Group:
test group
Dose level:
7.0% in petrolatum
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
One animal appeared equivocal result.
Remarks on result:
other: Reading: other: Challenge II. . Hours after challenge: 48.0. Group: test group. Dose level: 7.0% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: One animal appeared equivocal result..
Group:
negative control
Remarks on result:
other: No results provided for the negative control
Key result
Group:
positive control
Remarks on result:
positive indication of skin sensitisation
Remarks:
The isoeugenol gave a 100% response to Guinea Pig.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance appeared to be not sensitizing in Guinea pig maximization Test.
Executive summary:

This Guinea pig maximization test was conducted according to a method which similar to OECD Guideline 406.

The test substance appeared to be not sensitizing in Guinea pig maximization Test.