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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:
weight of evidence
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed in accordance with generally accepted scientific principles, with incomplete reporting on methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
An area on the backs of guinea pigs was clipped and kept free of fur, by chemical depilation, for the three week insult period. Each insult was applied to this area on days two and four of each week and consisted of 0.1 mL of the test solution on a 0.5 x 0.5 inch cotton square held in place and occluded with adhesive tape; squares were removed on days three and five of each week. Following the insult period, animals underwent a two week recovery period before their flanks were clipped and the unoccluded challenge applications of test solution applied. Readings for erythema and/or oedema at the challenge sites were made at 24 and 48 hours. The methodology followed was similar to Buehler (1965).
GLP compliance:
not specified
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): cyclohexene oxide

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 6-8 weeks old.

No further information presented on test animals and environmental conditions.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: perchloroethylene (Dowpre)
Concentration / amount:
0.5% solution.
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
other: perchloroethylene (Dowpre)
Concentration / amount:
0.5% solution.
No. of animals per dose:
10
Details on study design:
METHOD: similar to Buehler (1965)
An area above the forelegs was clipped electrically and chemically depilated with a wet paste of barium sulphide and TIDE detergent.
Depilation was carried out on day 1 of each week for 3 weeks.
Each application consisted of 0.1 ml of the test solution on 0.5 x 0.5 inch cotton square held in place and occluded with adhesive tape.
Induction applications were made on the 2nd and 4th day of each week and removed after 1 day.
Animals were rested for 2 weeks before challenge.

CHALLENGE:
The exposure sites were clipped and one flank exposed to 0.1 ml of the test solution and the contra-lateral was used as a control.

OBSERVATIONS:
At 24 and 48 hours.

SCORING:
Animals which displayed erythema and/or oedema at the test solution challenge site were recorded as a positive result.
Challenge controls:
A challenge control was used and the flank was exposed to 0.1 mL of the solvent vehicle.
Positive control substance(s):
yes
Remarks:
Epoxy Resin 331

Study design: in vivo (LLNA)

No. of animals per dose:
10

Results and discussion

In vivo (non-LLNA)

Results
Reading:
other: Positive responders
Hours after challenge:
48
Group:
test group
Dose level:
0.5% solution
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Two guinea pigs had scratched both of their flanks, which made evaluation more difficult. They were both considered negative results.
Remarks on result:
other: see Remark
Remarks:
Reading: other: Positive responders. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5% solution. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Two guinea pigs had scratched both of their flanks, which made evaluation more difficult. They were both considered negative results..

Any other information on results incl. tables

No further information on results is reported.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material is considered to be non-sensitising to the skin.
Executive summary:

The skin sensitisation of the test material was determined by exposing 10 Guinea pigs to the test material according to a method similar to Buehler (1965). During the study, an area on the backs of guinea pigs was clipped, and kept free of fur, by chemical depilation, for the three week insult period. Each insult was applied to this area on days two and four of each week and consisted of 0.1 ml of the test solution on a 0.5 x 0.5 inch cotton square held in place and occluded with adhesive tape; squares were removed on days three and five of each week. Following the insult period, animals underwent a two week recovery period before their flanks were clipped and the unoccluded challenge applications of test solution applied. Readings for erythema and/or oedema at the challenge sites were made at 24 and 48 hours. Under the conditions of the test it was determined that the test material is non-sensitising. None of the 10 test animals displayed a positive reaction.