Potassium dimethyldithiocarbamate

Skin irritation / corrosion

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

Test material information

Constituent 1

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

Results

Results 1

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

Results 2

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