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Skin sensitisation

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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: GLP guideline study with acceptable restrictions (GPMT is the preferred technique.)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
GPMT is the preferred technique.
Qualifier:
according to guideline
Guideline:
EPA OPP 81-6 (Skin Sensitisation)
Deviations:
no
Remarks:
No deviations to the Split Adjuvant Test.
GLP compliance:
yes
Type of study:
split adjuvant test
Justification for non-LLNA method:
The study was initiated prior to the implementation of the LLNA method.

Test material

Constituent 1
Chemical structure
Reference substance name:
Ziram
EC Number:
205-288-3
EC Name:
Ziram
Cas Number:
137-30-4
Molecular formula:
C6H12N2S4Zn
IUPAC Name:
ziram
Constituent 2
Reference substance name:
zinc bis dimethyldithiocarbamate
IUPAC Name:
zinc bis dimethyldithiocarbamate
Details on test material:
- Name of test material (as cited in study report): Ziram technical
- Lot no.: 8331 AA
- Purity: 99%

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
- Source: Charles River, Germany
- Age at study initiation: ca. 2 months
- Weight at study initiation: 287-413 g

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Induction: 25%
Challenge: 10, 5, 1 and 0%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Induction: 25%
Challenge: 10, 5, 1 and 0%
No. of animals per dose:
20
Positive control substance(s):
no

Results and discussion

Positive control results:
A positive control experiment was carried out in February 1987. The test substance was 37% formaldehyde solution.

Induction: 5% (w/w)
Challenge: 5%, 2% and 0.5%

A sensitization rate of 50% was obtained to the 0.5% concentration. 

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
other: not specified
Group:
positive control
Dose level:
37%
Clinical observations:
50% sensitization rate
Remarks on result:
other: no number of animals given, no time point for reading given
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
14
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
1
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
11
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5%
No. with + reactions:
1
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1%
No. with + reactions:
6
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
6
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other:
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
7
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1%
No. with + reactions:
6
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information