Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.

Data source

Reference
Reference Type:
other: SNIF
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

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
Route:
other: i.c., p.c.
Vehicle:
olive oil
Remarks:
DAB 9
Concentration / amount:
Concentration of test material and vehicle used in induction:
i.c.: 5 % in olive oil
p.c.: 25 % in olive oil

Concentration of test material and vehicle used for each challenge:
10% in olive oil DAB 9
Challengeopen allclose all
Route:
other: no data
Vehicle:
olive oil
Remarks:
DAB 9
Concentration / amount:
Concentration of test material and vehicle used in induction:
i.c.: 5 % in olive oil
p.c.: 25 % in olive oil

Concentration of test material and vehicle used for each challenge:
10% in olive oil DAB 9
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 10

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:
10
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: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
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: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
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: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
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: 10.0.

Any other information on results incl. tables

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

Signs of irritation during induction:

i.c.: significant redness, weak oedema

p.c.: significant redness, weak oedema, incrustation, partially open

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
The test substance was found to be not sensitising under the conditions of the test.