Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions concerning exposure duration

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
yes
Remarks:
Occlusive dressing; 24 h exposure time; 24 h-scoring time point is missing; post-exposure period was only 72 h; pH was 12.0
GLP compliance:
no

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
- Purity: no data
- Lot/batch No.: 1-6481

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Source: Dutchland Laboratories, Inc., Denver, PA, USA
Age: approx. 14 weeks
Weight: 2262-2597 g

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and intact, clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6
Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiping
- Time after start of exposure: 24 h


SCORING SYSTEM:
Erythema 0-4:
0: No erythema, 1: very slight erythema (barely perceptible), 2: well-defined erythema, 3 moderate to severe erythema, 4: severe erythema (beet redness) to slight eschar formation (injuries in depth)
Oedema 0-4:
0: No oedema, 1: very slight oedema (barely perceptible), 2: well-defined oedema (edges of area well-defined by definite raising), 3: moderate to severe oedema (raised approximately 1mm), 4: severe oedema (raised more than 1 mm extending beyond the area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48+72 h
Score:
3.48
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48+72 h
Score:
2.88
Max. score:
3.25
Reversibility:
not fully reversible within: 72 h
Other effects:
Blanching of the test area was seen in most animals at all scoring time points. In addition to this, subcutaneous haemorrhage and areas of necrosis in the test area occurred frequently.

Any other information on results incl. tables

Table A6.1.4S-1   Results of skin irritation study *

Observation time

E

Oe

E

Oe

E

Oe

E

Oe

E

Oe

E

Oe

         24 h**

4.00

4.00

3.00

3.50

3.50

3.25

3.25

3.50

4.00

3.50

3.50

3.50

48 h

4.00

2.50

    –#

4.00

3.00

2.50

2.00

4.00

3.25

2.50

2.50

72 h

4.00

2.25

4.00

2.75

2.50

2.00

4.00

3.00

2.50

2.25

Mean value
24 + 48 + 72 h

4.00

2.92

3.83

3.00

2.75

2.50

4.00

3.25

2.83

2.75

*   Values are means of both test sites

** Scoring time point: immediately after removal of test patch

#   Animal died on test

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU

Categories Display