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Diss Factsheets

Administrative data

Description of key information

In an OECD 406 and GLP study, no skin sensitization related to the substance was reported.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A non-LLNA method was conducted instead of a LLNA assay as at that time (2001), no LLNA guideline (OECD 429) was available.
Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Route:
intradermal and epicutaneous
Vehicle:
olive oil
Concentration / amount:
intradermal: 1% in olive oil
epicutaneous: 6% in vaseline after irritating with lauryl sulfate
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
intradermal: 1% in olive oil
epicutaneous: 6% in vaseline after irritating with lauryl sulfate
No. of animals per dose:
20
Challenge controls:
no reported
Positive control substance(s):
yes
Remarks:
Kaptax, EC n°205-736-8
Positive control results:
no reported
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
6%
No. with + reactions:
9
Total no. in group:
20
Clinical observations:
light erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 6%. No with. + reactions: 9.0. Total no. in groups: 20.0. Clinical observations: light erythema.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3%
No. with + reactions:
7
Total no. in group:
20
Clinical observations:
light erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3%. No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: light erythema.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no reaction
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no reaction.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
6%
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
light erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 6%. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: light erythema.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
3%
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
light erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 3%. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: light erythema.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no reaction
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no reaction.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
6%
No. with + reactions:
7
Total no. in group:
20
Clinical observations:
light erythema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 6%. No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: light erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
3%
No. with + reactions:
6
Total no. in group:
20
Clinical observations:
light erythema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3%. No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: light erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no reaction
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no reaction.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
6%
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
light erythema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 6%. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: light erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
3%
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
light erythema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 3%. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: light erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no reaction
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no reaction.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
6%
No. with + reactions:
6
Total no. in group:
20
Clinical observations:
3 animals with desquamation
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 6%. No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: 3 animals with desquamation.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
3%
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
1 animal with desquamation
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 3%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: 1 animal with desquamation.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no reaction
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no reaction.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
6%
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
light erythema
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 6%. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: light erythema.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
3%
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
light erythema
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 3%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: light erythema.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no reaction
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no reaction.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
2%
No. with + reactions:
7
Total no. in group:
20
Clinical observations:
light erythema
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 2%. No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: light erythema.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
2%
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
light erythema
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 2%. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: light erythema.
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
not sensitising
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
In the experimental conditions, the exposure to 6% in vaseline of test substance in 20 guinea pigs produced light to moderate erythemae to animal 8176 up to 45% after 24h, 35% after 48h and 30% after 72 h of animals.
In a concentration of 3% the positive reactions after 24, 48 and 72h were of 35; 30 and 25% of animals respectively.
In the same conditions, a light to moderate erythema has been observed on 40% of anilmals.
These results suggest a hyper-irritation reaction.
To check the observed results the same animals were exposed to a concentration of 2 and 1% in vaseline of the tested substance.
As this reaction was observed in the 2 groups of animals (control and exposed ones), this reaction is considered not to be related to any sensitization reaction to the test substance.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Given the absence of test-related skin sensitization in the OECD 406 study, no classification for skin sensitization is warranted.