Potassium dimethyldithiocarbamate

Eye irritation

Administrative data

Endpoint:

eye 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 (GLP is missing)

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 81-4 (Acute Eye Irritation)

Deviations:

no

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 number: 1-6481

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dutchland Laboratories, Inc., Denver, PA, USA
- Age at study initiation: approx. 14 weeks
- Weight at study initiation: 2152-2665 g

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

24 h

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): one group of rabbits received eye washing, the other group received no washing
- Time after start of exposure: 30 sec

SCORING SYSTEM:
Cornea
Degree of Opacity 0 – 4 (0 = no finding, 1 = slight, disperse, diffuse opacity, 2 = extensive, diffuse opacity, iris blurred, 3 = mother-of-pearl-like opacity, iris and pupil hardly recognisable, 4 = complete opacity, ulceration)
Iris 0 – 2 (0 = no finding, 1 = swelling, reddening, positive light reaction, 2 = severe reddening and swelling, no light reaction)
Conjunctivae
Redness 0 – 3 (0 = blood vessels normal, 1 = vessels abnormally filled, 2 = diffuse reddening, 3 = diffuse deep reddening)
Chemosis 0 – 4 (0 = no swelling, 1 = slight swelling, 2 =severe swelling, lids everted, 3 = lids cover one half of eye, 4 = lids cover more than half eye, necroses and ulcers on the conjunctivas)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.11

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.33

Reversibility:

fully reversible within: 72 h

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

1.89

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

1.22

Max. score:

2

Reversibility:

fully reversible within: 7 days

Any other information on results incl. tables

Table A6.1.4E-1  Results of eye irritation study
Observation time [h]*	Cornea	Iris	Conjunctiva
			Redness	Chemosis
	0 to 4	0 to 2	0 to 3	0 to 4
24	0.33	0.50	2.00	1.25
48	0.00	0.33	1.92	1.33
72	0.00	0.17	1.75	1.08
Average 24, 48, 72 h	0.11	0.33	1.89	1.22
Reversibility **	c	c	c	c
Average time for reversion	48 h	72 h	14 d	7 d
*    Average of animals investigated (without eye washing) **     c     completely reversible

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU