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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Induction and challenge concentration were the same; positive controls were not reported
GLP compliance:
yes
Type of study:
Buehler test

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium dimethyldithiocarbamate
EC Number:
204-875-1
EC Name:
Potassium dimethyldithiocarbamate
Cas Number:
128-03-0
Molecular formula:
C3H7NS2.K
IUPAC Name:
potassium (dimethylcarbamothioyl)sulfanide
Details on test material:
- Name of test material (as cited in study report): Busan 85
- Physical state: Yellow-green liquid
- Analytical purity: 50%
- Stability under test conditions: one year
- Storage condition of test material: RT

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Details on test animals and environmental conditions:
Source: Hazleton/Dutchland, Denver, PA, USA
Weight at study initiation: 271-604 g

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
40% v/v for induction+challenge
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
40% v/v for induction+challenge
No. of animals per dose:
Test group: 10/sex
Control group: 7/sex (5/sex for challenge; 2/sex for rechallenge)
Details on study design:
RANGE FINDING TESTS:
10, 25, 40% were tested in 4 animals. Exposure time was 6 h, animals were scored 24 and 48 h after start of exposure.
40% v/v was selected for use in the induction and challenge phase as the highest non-irritating dose.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: 20 animals
- Control group: 10 animals
- Site: left anterior quadrant
- Concentrations: 40%


B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 1st challenge: Day 28; re-challenge: not specified
- Exposure period: 6 h
- Test groups:
- Control group:
- Site: left posterior quadrant (1st challellenge), right anterior quadrant (re-challenge)
- Concentrations: 40%
- Evaluation (hr after challenge): 24+48 h
Challenge controls:
naive animals
Positive control substance(s):
no

Results and discussion

Positive control results:
n.a.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
40%
No. with + reactions:
0
Total no. in group:
19
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: 19.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
40%
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: 40%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
40%
No. with + reactions:
1
Total no. in group:
19
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 40%. No with. + reactions: 1.0. Total no. in groups: 19.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
40%
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: 40%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
40%
No. with + reactions:
1
Total no. in group:
13
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 40%. No with. + reactions: 1.0. Total no. in groups: 13.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
40%
No. with + reactions:
0
Total no. in group:
3
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 40%. No with. + reactions: 0.0. Total no. in groups: 3.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
40%
No. with + reactions:
3
Total no. in group:
13
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 40%. No with. + reactions: 3.0. Total no. in groups: 13.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
40%
No. with + reactions:
0
Total no. in group:
3
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 40%. No with. + reactions: 0.0. Total no. in groups: 3.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information