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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:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
This test was already available (it was performed for cosmetic regulation compliance), before REACH regulation requirements.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Species : Hartley albino guinea-pigs
Weight at the beginning of acclimatization : inferior or equal to 500 g (main test)
Sex : males and nulliparous and non-pregnant females
Number : 34

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Day(s)/duration:
6 hours, repeated at weekly intervals (days 8 and 15 of the study)
Adequacy of induction:
highest technically applicable concentration used
Challenge
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
petrolatum
Concentration / amount:
100%, 0.5ml and 50%, 0.2ml
100% of vehicle, 0.5ml
Day(s)/duration:
6 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
The 32 animals were distributed between the treated group (22 animals) and the control group (10 animals) at random
Details on study design:
The patch was composed of a 4 cm2 cotton pad (2 cm x 2 cm), put on a square of Blenderm® occlusive film of appropriate size.
Challenge controls:
On day one, 8th and 10th, 0.5 ml of vehicle was deposited on the patch composed of a 4 cm2 cotton pad (2 cm x 2 cm), put on a square of Blenderm® occlusive film of appropriate size. The occlusive dressing was held in contact for 6 hours ± 10 minutes with a Micropore® hypoallergenic adhesive film which surrounded the trunk of the animal. The substance was held for 6h.
On day 29, 0.5 ml of the vehicle alone was put on a similar patch applied to the other flank than the test preparation.
Positive control substance(s):
no

Results and discussion

Positive control results:
Not tested

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
3
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
2
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
1
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
1
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100% of vehicle selected for challenge i.e. acetone
No. with + reactions:
1
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100% of vehicle selected for challenge i.e. acetone
No. with + reactions:
1
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100% of vehicle selected for challenge i.e. acetone. Challenge with 100% vehicle or 100% or 50% of test substance
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100% of vehicle selected for challenge i.e. acetone. Challenge with 100% vehicle or 100% or 50% of test substance
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested
Reading:
2nd reading
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

The skin sensitization test was performed according to OECD 406 guideline. The data indicate that, in the guinea pig, the test product does not elicit a sensitisation response.