Reaction products of 2,5-dimercapto-1,3,4-thiadiazole, sodium salt, with 1-octanethiol and hydrogen peroxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 1983 to 19 September 1983

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-(octyldisulfanyl)octane; 2-(octyldisulfanyl)-5-[(octylsulfanyl)disulfanyl]-1,3,4-thiadiazole; 2-(octyldisulfanyl)-5-{[5-(octyldisulfanyl)-1,3,4-thiadiazol-2-yl]sulfanyl}-1,3,4-thiadiazole; bis(octyldisulfanyl)-1,3,4-thiadiazole

EC Number:

948-020-7

Molecular formula:

N/A

IUPAC Name:

1-(octyldisulfanyl)octane; 2-(octyldisulfanyl)-5-[(octylsulfanyl)disulfanyl]-1,3,4-thiadiazole; 2-(octyldisulfanyl)-5-{[5-(octyldisulfanyl)-1,3,4-thiadiazol-2-yl]sulfanyl}-1,3,4-thiadiazole; bis(octyldisulfanyl)-1,3,4-thiadiazole

Test material form:

liquid

Details on test material:

EC Number: 948-020-7

Test animals

Species:

rabbit

Strain:

other: New England White

Details on test animals or test system and environmental conditions:

SOURCE ANIMAL
- Source: Externally sourced
- Sex: Male
- Weight at study initiation: Ranges from 2.38 to 2.96 Kg
- Housing: All housing and care conformed to the standards established in "Guide for the Care and Use of Laboratory Animals" DHEW Publication No. (NIH) 78-23. Animals were individually housed in wire mesh bottom cages in an environment controlled room.
- Diet: The rabbits were provided NIH Animal Feed A (certified) ad libitum
- Water: ad libitum
- Acclimation period: A minimum of 5 days

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

A volume of 0.5 ml of the test article was applied to each of 2 sites per rabbit.

Duration of treatment / exposure:

4 hours

Observation period:

30 minutes, 24, 48 and 72 hours

Number of animals:

6 animals

Details on study design:

TEST SITE
- Type of wrap if used: Following application, each test site was occluded with a one-inch square gauze patch and Blenderm® tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gently wiped with clean gauze.

OBSERVATION TIME POINTS
- 30 minutes after test material removal and the exposure sites were again examined and scored 24, 48 and 72 hours after unwrapping. Any extraordinary findings, dermal or toxicological, were noted. The animals were also observed and scored on days 4, 7, 10 and 14.

SCORING SYSTEM:
- Method of calculation:the exposure sites were examined and scored separately for both erythema and edema on a graded scale of 0 to 4 in accordance with the Driaze scale.

Results and discussion

In vivo

Results

Irritation parameter:

other: Draize scale

Remarks:

erythema/eschar and oedema

Basis:

mean

Time point:

24/48/72 h

Score:

3.11

Reversibility:

not specified

Remarks on result:

probability of mild irritation

Any other information on results incl. tables

Patches were removed approximately 4 hours after application and excess test substance was removed. At 0.5, 24, 48 and 72 hours after patches removed, the exposure sites were examined and scored separately for both erythema/eschar and oedema on a graded scale of 0 to 4 in accordance with the Skin Reaction Code. The animals were also observed and scored on days 4, 7, 10 and 14. Eschar formation was noted at the test site in 3/6 animals on days 3 and 4. On days 7 and 10, 2/6 animals exhibited eschar formation and 4/6 animals exhibited cracked, flaking skin on the surface layer of the test site. Day 14 observations revealed eschar formation in 1/6 animal and 5/6 animals exhibited cracked, flaking skin on the surface layer of the test site. The individual primary irritation score was that total scores of erythema/eschar and oedema at 0.5, 24, 48 and 72 hours after patches removed divided by 6. The mean primary irritation score of six rabbits was 3.11. The test substance was considered to be moderately irritating to the skin of rabbits.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test substance was considered to be moderately irritating to the skin of rabbits.

Executive summary:

To determine the potential of the test material to cause irritation to the skin a study was conducted in accordance to OECD guidelines under GLP conditions. The study has been given a Klimisch score of 1 and is considered to be a key study. Six male New England White rabbits were treated with 0.5 mL test material/site, 2 sites/rabbit; occlusive coverage for 4 hour treatment. Patches were removed approximately 4 hours after application and excess test substance was removed. At 0.5, 24, 48 and 72 hours after patches removed, the exposure sites were examined and scored separately for both erythema/eschar and oedema on a graded scale of 0 to 4 in accordance with the Skin Reaction Code. The animals were also observed and scored on days 4, 7, 10 and 14. Eschar formation was noted at the test site in 3/6 animals on days 3 and 4. On days 7 and 10, 2/6 animals exhibited eschar formation and 4/6 animals exhibited cracked, flaking skin on the surface layer of the test site. Day 14 observations revealed eschar formation in 1/6 animal and 5/6 animals exhibited cracked, flaking skin on the surface layer of the test site. The individual primary irritation score was that total scores of erythema/eschar and oedema at 0.5, 24, 48 and 72 hours after patches removed divided by 6. The mean primary irritation score of six rabbits was 3.11. Under the conditions of this study, the test substance was considered to be moderately irritating to the skin of rabbits.