Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: report available, GLP study;

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Unnamed
Year:
1995
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
no data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: intradermal: Alembicol D (triglyceride); epidermal: water
Concentration / amount:
intradermal: 7.5 % (w/w)
epidermal: induction: 75 %
epidermal: induction: 75 and 40 %
Challengeopen allclose all
Route:
other: epicutaneous, no further data
Vehicle:
other: intradermal: Alembicol D (triglyceride); epidermal: water
Concentration / amount:
intradermal: 7.5 % (w/w)
epidermal: induction: 75 %
epidermal: induction: 75 and 40 %
No. of animals per dose:
20
Details on study design:
RANGE FINDING TESTS: no data

MAIN STUDY
- No. of exposures: 2
- Test groups: 1
- Control group: 1
Positive control substance(s):
no
Remarks:
Formalin was tested as a positive control regulaly but not included in this study

Results and discussion

Positive control results:
no data

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
40 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 40 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
40 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 40 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Classification: not sensitizing