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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:
weight of evidence
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
according to
Guideline:
other: "Allergic Contact Dermatitis in the Guinea-Pig: Identification of Contact Allergens" Magnusson B. Kligman A.M., 1970 published by C.C. Thomas, Springfield, Illinois, USA
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
data were already available

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The identity of the test material concerns the same ECnumber as the substance in section 1. The purity of the test material is not described in the report, and thus might differ from the purity of the substance in section 1.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
intradermal injection with a 1% concentration and epidermal occlusive exposure (both in induction and challenge phase) to a 50% concentration
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
intradermal injection with a 1% concentration and epidermal occlusive exposure (both in induction and challenge phase) to a 50% concentration
No. of animals per dose:
10 females in experimental group
5 females in negative control group
Details on study design:
Challenge assessment: 24 and 48 hours after removal of the dressing
Challenge controls:
5 females
Positive control substance(s):
yes
Remarks:
alpha-hexylcinnamic aldehyde, tech. 85%

Results and discussion

Positive control results:
sensitisation rate of 80% to a 10% concentration of the positive control substance

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: challenge
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Green/brown staining was observed at all test substance treated skin sites, 24 and 48 hours after challenge. This staining did not hamper the scoring of the skin reactions.
Remarks on result:
other: see Remark
Remarks:
Reading: other: challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 50% . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Green/brown staining was observed at all test substance treated skin sites, 24 and 48 hours after challenge. This staining did not hamper the scoring of the skin reactions..
Reading:
other: challenge
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
see challenge results at 24 hours after challenge.
Remarks on result:
other: Reading: other: challenge. . Hours after challenge: 48.0. Group: test group. Dose level: 50% . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: see challenge results at 24 hours after challenge..
Reading:
other: challenge
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: other: challenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
other: challenge
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: other: challenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% . No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
other: challenge
Hours after challenge:
48
Group:
other: testgroup + negative control
Dose level:
water
No. with + reactions:
0
Total no. in group:
15
Remarks on result:
other: Reading: other: challenge. . Hours after challenge: 48.0. Group: other: testgroup + negative control. Dose level: water. No with. + reactions: 0.0. Total no. in groups: 15.0.

Any other information on results incl. tables

Toxicity/mortality: no mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study

Body weights: body weights and body weight gain of experimental animals reamined in the same range as controls over the study period

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU