Registration Dossier

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 according EU/OECD guideline

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
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: Hsd Poc:DH
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Vehicle:
polyethylene glycol
Concentration / amount:
Intradermal induction: 5% (= 20 mg test item/animal)
Topical induction: 50% (= 250 mg test item/animal)
Challenge: 25% (= 125 mg test item/animal)
Challengeopen allclose all
Vehicle:
polyethylene glycol
Concentration / amount:
Intradermal induction: 5% (= 20 mg test item/animal)
Topical induction: 50% (= 250 mg test item/animal)
Challenge: 25% (= 125 mg test item/animal)
No. of animals per dose:
test item group: 10
control group: 5

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

In a Guinea Pig Maximization Test the test substance was examined in female guinea pigs for its skin sensitizing properties. The intradermal induction was performed using a 5% test item concentration, and the topical induction was performed with a 50% test item concentration. The test item was formulated in polyethylene glycol 400 to yield a solution. After the intradermal induction the animals in the control group and in the test item group showed strong effects up to encrustation at the injection sites of the first induction. The challenge using a 25% test item formulation led to no skin effects in the treatment group and the control group.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In summary, by comparing the results in the treatment group and in the control group under the conditions of the maximization test and with respect to the evaluation criteria the test item therefore exhibits no skin-sensitization potential.