Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: ECHA diss. Dossier: GLP guideline study; documentation sufficient for assessment

Data source

Reference
Reference Type:
other: ECHA diss. Dossier
Title:
Skin sensitisation
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
LLNA was not established when the skin sensitization test was conducted

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
1 %, 0.1 mL per injection
Route:
other: epicutaneous
Vehicle:
other: vaseline
Concentration / amount:
50 %, 0.4 g paste per patch
Challenge
No.:
#1
Route:
other: epicutaneous
Vehicle:
other: vaseline
Concentration / amount:
50 %, 0.2 g paste per patch
No. of animals per dose:
test group: 20
control group: 10

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
0.2 g
No. with + reactions:
7
Total no. in group:
20
Clinical observations:
slight to well defined erythema, very slight edema
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
0.2 g
No. with + reactions:
11
Total no. in group:
20
Clinical observations:
slight to well defined erythema, very slight edema
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
20

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria