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: Guideline study, GLP compliance

Data source

Reference
Reference Type:
other: study summaries submitted to ECHA more than 12 years ago
Title:
Unnamed
Year:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 84/449/EWG, B.6(MeerschwelnchElO-Maxlmlerungstest (GPMT)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
other: gpg, Plrbrlght WhileTlf:DHP

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of testmaterial andvehicle used at Induction:
a) Intradermal: 5% Insesame oil
b) Epidermal: 30% in vaseline

Concentration of test material andvehicle used for each challenge:
a) 10% In vaseline
Challenge
Concentration / amount:
Concentration of testmaterial andvehicle used at Induction:
a) Intradermal: 5% Insesame oil
b) Epidermal: 30% in vaseline

Concentration of test material andvehicle used for each challenge:
a) 10% In vaseline
No. of animals per dose:
Number of animals In testgroup: 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
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.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
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.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
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.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
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.

Applicant's summary and conclusion

Interpretation of results:
other: not classified