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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 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 405 (Acute Eye 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

Specific details on test material used for the study:

Sponsor Test Article ID : OD-826, Lot #DU71/2

Test animals / tissue source

Species:

rabbit

Strain:

other: New England White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Externally sourced
- Sex: Female
- Weight at study initiation: Ranged from 2.36 to 2.78 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. The rabbits were individually housed in wire mesh bottom cages in an environment controlled room.
- Diet: NIH Animal Feed A (certified), ad libitum
- Water: as libitum
- Acclimation period: A minimum of 5 days

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.1 ml of the test substance

Duration of treatment / exposure:

1 dose / 14 days exposure

Observation period (in vivo):

1, 24, 48 and 72 hours. Readings were made every 3 day thereafter, if injury persisted, for at least 13 days after treatment.

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not specified

SCORING SYSTEM:
- Draize Scale

TOOL USED TO ASSESS SCORE:
- Sodium fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Draize Scale

Remarks:

Mean Eye Irritation Scores

Basis:

mean

Time point:

other: 1 hour

Score:

6

Reversibility:

not specified

Results 2

Irritation parameter:

other: Draize Scale

Remarks:

Mean Eye Irritation Scores

Basis:

mean

Time point:

24 h

Score:

0.7

Reversibility:

not specified

Results 3

Irritation parameter:

other: Draize Scale

Remarks:

Mean Eye Irritation Scores

Basis:

mean

Time point:

48 h

Score:

0.3

Reversibility:

not specified

Results 4

Irritation parameter:

other: Draize Scale

Remarks:

Mean Eye Irritation Scores

Basis:

mean

Time point:

72 h

Score:

0

Reversibility:

not specified

Any other information on results incl. tables

The treated eyes were examined with the aid of sodium fluorescein and the grade of ocular reaction was recorded for all animals at l, 24, 48 and 72 hours using the Draize Scale for Scoring Ocular Lesions. Readings were made every 3 day thereafter, if injury persisted, for at least 13 days after treatment or until all signs of reversible toxicity subsided. The mean eye irritation scores were 6.0, 0.7, 0.3 and 0 at l, 24, 48 and 72 hours, respectively. The test substance was considered to be moderately irritating to the eye of rabbits.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the study, the test substance was considered to be moderately irritating to the eye of rabbits. The results indicate no means scores above 1 after 24 hours and fully reversed by 72 hours.

Executive summary:

To determine the potential of the test material to cause irritation to the eye 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 female New England White rabbits were treated with 0.1 mL test material in one eye and the other eye remained untreated and this was used as a control. The treated eyes were examined with the aid of sodium fluorescein and the grade of ocular reaction was recorded for all animals at 1, 24, 48 and 72 hours using the Draize Scale for Scoring Ocular Lesions. Readings were made every 3 day thereafter, if injury persisted, for at least 13 days after treatment or until all signs of reversible toxicity subsided. The mean eye irritation scores were 6.0, 0.7, 0.3 and 0 at 1, 24, 48 and 72 hours, respectively. The test substance was considered to be moderately irritating to the eye of rabbits.