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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:
2010-2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The test was conducted according to recommended guideline. The deviations from the test method were necessary considering the insolubility of the substance in vehicles required by guinea pig maximization test (GPMT). For the same issue LLNA assay could not be performed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
test modified according to Maurer & Hess (see reference)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
yes
Remarks:
test modified according to Maurer & Hess (see reference)
Principles of method if other than guideline:
The test substance was applied to the skin by means of epicutaneous patch because it was not soluble in the common vehicles used in the guinea pig maximisation test (GPMT).
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
According to physicochemical properties of the substance, LLNA method was considered not suitable.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
room temperature: step 1. mean of 20,84°C
step 2. mean of 21,03°C

relative humidity: step 1. Mean of 31,22% r.F.
step 2 Mean of 17,35% r.F.

air exchange: approximatly 12/h

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
The test substance was applied a concentration of 50% (w/w) in white petrolatum during both the induction phase and the challenge exposure.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
The test substance was applied a concentration of 50% (w/w) in white petrolatum during both the induction phase and the challenge exposure.
No. of animals per dose:
test substance: 20
negative control: 10
Details on study design:
Day 0: removal of fur, recording of body mass, intradermal FCA administration and epicutaneous administration of the test substance

Day 1: end of epicutaneous induction exposure

Day 2: skin examination

Day 6: removal of hair, treatment with n-dodecylsulfate, sodium salt

Day 7: epicutaneous induction exposure

Day 9: end of the epicutaneous induction exposure

Day 10: skin examination

Day 21: removal of hair, epicutaneous challenge exposure

Day 22: end of epicutaneous challenge period

Day 23: approximately 21 hours after removing the patch cleaning of the challenge area, approximately 3 hours later skin examination

Day 24: skin examination, recording of body mass, sacrifice of animals, end of test
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50% (w/w)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No clinical signs observed.
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50% (w/w)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No clinical signs observed
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50% (w/w)
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No clinical signs observed
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50% (w/w)
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No clinical signs observed.
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
hexyl cynnamic aldehyde 10%
No. with + reactions:
7
Total no. in group:
10
Clinical observations:
-
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
hexyl cynnamic aldehyde 10%
No. with + reactions:
7
Total no. in group:
10
Clinical observations:
-
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, study results indicate that the substance should not be classified for skin sensitisation.