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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:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
An appropriate guinea pig maximisation test is available therefore an additional LLNA test was deemed unnecessary due to animal welfare.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
not specified
Challengeopen allclose all
No.:
#1
Route:
intradermal and epicutaneous
Vehicle:
not specified
Concentration / amount:
0
No.:
#2
Route:
intradermal and epicutaneous
Vehicle:
not specified
Concentration / amount:
0.1%
No.:
#3
Route:
intradermal and epicutaneous
Vehicle:
not specified
Concentration / amount:
0.2%
No.:
#4
Route:
intradermal and epicutaneous
Vehicle:
not specified
Concentration / amount:
0.5%
No. of animals per dose:
20
Challenge controls:
One control group for each challenge
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
test group
Dose level:
0.1%
No. with + reactions:
2
Total no. in group:
20
Reading:
1st reading
Group:
test group
Dose level:
0.2%
No. with + reactions:
4
Total no. in group:
20
Reading:
1st reading
Group:
test group
Dose level:
0.5%
No. with + reactions:
14
Total no. in group:
20
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
Category 1A (indication of significant skin sensitising potential) based on GHS criteria
Conclusions:
Under the conditions used in this study, V190110 resulted in a sensitisation rate of 75 per cent after intracutaneous and epicutaneous application to the guinea pig.