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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: well documented and scientifically acceptable

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
On day 1, 0.1 ml of the test substance was administered by intradermal route at the concentration of 0.1 % in paraffin oil and on day 9 0.5 ml of the test substance was applied by cutaneous route at the concentration of 1%. After a period of 15 days without treatment, a challenge cutaneous application of the vehicle (left flank) and the test substance at the concentration of 1% (right flank) was performed in all the animals. The test substance and the vehicle were held in contact with the skin for 24 hours by an occlusive dressing. The cutaneous reactions were evaluated at the challenge application site, 24 hours and 48 hours after the removal of the dressing.
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test performed prior to LLNA guideline

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
test substance EXT 8813

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
paraffin oil
Concentration / amount:
1 %
Challenge
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
1 %
No. of animals per dose:
10

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1 %
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
erythema
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1 %
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
edema
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1 %
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
erythema
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1 %
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
edema

Any other information on results incl. tables

no further data

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
The test item is considered to be sensitising in this guinea pig maximisation test.
Executive summary:

On day 1, 0.1 mL of the test substance was administered by intradermal route at the concentration of 0.1 % in paraffin oil and on day 9, 0.5 mL of the test substance was applied by cutaneous route at the concentration of 1%. After a period of 15 days without treatment, a challenge cutaneous application of the vehicle (left flank) and the test substance at the concentration of 1% (right flank) was performed in all the animals. The test substance and the vehicle were held in contact with the skin for 24 hours by an occlusive dressing. The cutaneous reactions were evaluated at the challenge application site, 24 hours and 48 hours after the removal of the dressing.

Result: positive