Zinc bis(N-ethyl-N-phenyldithiocarbamate)

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:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

An amount of 0.5 g of the test substance was brought on the intact or abraded skin under a surgical patch measuring 1 x 1 inch. The patches were fixed to the application site by means of adhesive tape and the entire trunk of the rabbits was wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances. Six rabbits are treated on the intact skin, the other six on the abraded skin. After an exposure period of 24 hours the patches and the material applied are removed and the resulting skin reactions were evaluated by the method of Draize.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Zinc bis(N-ethyl-N-phenyldithiocarbamate)

EC Number:

238-677-1

EC Name:

Zinc bis(N-ethyl-N-phenyldithiocarbamate)

Cas Number:

14634-93-6

Molecular formula:

C18H20N2S4Zn

IUPAC Name:

zinc bis(N-ethyl-N-phenyldithiocarbamate)

Specific details on test material used for the study:

WTR 44 = Vulkacit P = CAS no. 14634-93-6
White powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Twelve healty adult New Zealand White albino rabbits were used for the test. Twenty four hours prior to applying the materials, the hair was removed from the backs of the animals with an electric clipper in such a way to avoid abrasions.

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

12 animals

Details on study design:

After an exposure period of 24 hours the patches and the material applied were removed and the resulting skin reactions are evaluated by the method of Draize. A second reading was made 48 hours later (72 hours after application).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: score = 0 at any time point

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: score = 0 at any time point

Irritant / corrosive response data:

No signs of skin irritation could be detected in any of the test animals, either at the end of the 24-hour application period or 48 hours later.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No signs of skin irritation could be detected in any of the test animals, either at the end of the 24-hour application period or 48 hours later.

Executive summary:

An amount of 0.5 g of the test substance was brought on the intact or abraded skin under a surgical patch measuring 1 x 1 inch. The patches were fixed to the application site by means of adhesive tape and the entire trunk of the rabbits was wrapped with an impervious matrial to maintain the test patches in position and to retard evaporation of volatile substances. Six rabbits are treated on the intact skin, the other six on the abraded skin. After an exposure period of 24 hours the patches and the material applied are removed and the resulting skin reactions were evaluated by the method of Draize. No signs of skin irritation could be detected in any of the test animals, either at the end of the 24-hour application period or 48 hours later.