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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
Study period:
1978
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: Landsteiner and Jacobs guinea pig technique
Principles of method if other than guideline:
Undiluted ingredient was applied topically.
The backs and flanks of male guinea pigs were clipped, and treatments were made three times a week for a total of 10 treatments.
The first treatment consisted of 0.05 ml, and the remaining nine were 0.1 ml each.
A challenge treatment of 0.05 ml was made two weeks after the tenth sensitization treatment.
there was reported minimal skin irritation but no sensitization
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
very old study (1978)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: flakes
Specific details on test material used for the study:
undiluted

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
first 0.05 ml and 9 at 0.1 ml
Day(s)/duration:
3 weeks
Adequacy of induction:
not specified
Challenge
No.:
#10
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.05 ml
Day(s)/duration:
3 weeks of treatment and 2 weeks after challenge
Adequacy of challenge:
other: 0.05 ml
No. of animals per dose:
10 animals
Details on study design:
Undiluted ingredient was applied topically.
The backs and flanks of male guinea pigs were clipped, and treatments were made three times a week for a total of 10 treatments.
The first treatment consisted of 0.05 ml, and the remaining nine were 0.1 ml each.
A challenge treatment of 0.05 ml was made two weeks after the tenth sensitization treatment.
there was reported minimal skin irritation but no sensitization
Challenge controls:
no sensitization observed
Positive control substance(s):
no

Results and discussion

Positive control results:
in the test group, no sensitization was observed

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.05 ml
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
0.1 ml
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
0
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
0
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0
No. with + reactions:
0
Total no. in group:
0
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
positive control
Dose level:
0
No. with + reactions:
0
Total no. in group:
0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met