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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)
Rationale for reliability incl. deficiencies:
other: GLP-study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Ibm: GOHI, SPF-quality
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Intradermal induction: 5 % in Polyethylene glycol; Epidermal induction: 15 % in vaselinum album
Concentration / amount:
Pretest: 5; 3 and 1 % test article in polyethylene gylcol (intradermal injections (0.1 mL/site)
Main test induction: 5 % test article in polyethylene glycol
Main test challenge: 5 % in vaselinum album
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
other: Intradermal induction: 5 % in Polyethylene glycol; Epidermal induction: 15 % in vaselinum album
Concentration / amount:
Pretest: 5; 3 and 1 % test article in polyethylene gylcol (intradermal injections (0.1 mL/site)
Main test induction: 5 % test article in polyethylene glycol
Main test challenge: 5 % in vaselinum album
No. of animals per dose:
Number of animals main study/pretest: 30 females/6 females

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
other: Control group
Dose level:
0 % (right flank)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Control group. Dose level: 0 % (right flank). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured..
Reading:
1st reading
Hours after challenge:
48
Group:
other: Control group
Dose level:
0 % (right flank)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 48.0. Group: other: Control group. Dose level: 0 % (right flank). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured..
Reading:
1st reading
Hours after challenge:
24
Group:
other: Control group
Dose level:
5 % (left flank)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Control group. Dose level: 5 % (left flank). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured..
Reading:
1st reading
Hours after challenge:
48
Group:
other: Control group
Dose level:
5 % (left flank)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 48.0. Group: other: Control group. Dose level: 5 % (left flank). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured..
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
5 % (left flank)
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 % (left flank). No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured..
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
5 % (left flank)
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 % (left flank). No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured..
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0 % (right flank)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0 % (right flank). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured..
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
0 % (right flank)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0 % (right flank). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured..
Reading:
2nd reading
Hours after challenge:
24
Group:
other: Control group
Dose level:
0 % (left flank)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured.
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 24.0. Group: other: Control group. Dose level: 0 % (left flank). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured..
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Control group
Dose level:
0 % (left flank)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured.
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Control group. Dose level: 0 % (left flank). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured..
Reading:
2nd reading
Hours after challenge:
24
Group:
test group
Dose level:
5 % (right flank)
No. with + reactions:
8
Total no. in group:
20
Clinical observations:
No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured.
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 % (right flank). No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured..
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
5 % (right flank)
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured.
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 % (right flank). No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured..
Reading:
2nd reading
Hours after challenge:
24
Group:
test group
Dose level:
0 % (left flank)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured.
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0 % (left flank). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured..
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0 % (left flank)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured.
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0 % (left flank). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No toxic symptoms were evident in the guinea pigs of the control or test group. No death occured..

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
The results were interpreted according to the rating of Magnusson and Kligman (1969). The TS is considered to be a sensitizer.