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: Test was conducted according to Directive 84/449/EEC, B.6 (GPMT) and compliant with GLP.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Directive 84/449/EEC, B.6 (GPMT)
Deviations:
not specified
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: Pirbright White
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Vehicle:
other: vaseline
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) 30% in Vaseline
b) 30% in Vaseline
Concentration of test material and vehicle used for each challenge:
a) 10% in Vaseline
Challengeopen allclose all
Vehicle:
other: vaseline
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) 30% in Vaseline
b) 30% in Vaseline
Concentration of test material and vehicle used for each challenge:
a) 10% in Vaseline
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 20

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 10 %

Signs of irritation during induction: no findings

Evidence of sensitisation of each challenge concentration: none

Other observations: Erythema was observed in one of the four animals in the pretest (during 24 h after the occlusive application of 30% of the test substance in vaseline).

Since the test substance is insoluble in standard vehicles, in the induction phase it was applied via the sites of puncture.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Conclusions:
The substance was considered to be a non-sensitiser under the conditions of the GPMT.