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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 1983 to September 1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

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:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: - Young adult male and female Sprague-Dawley rats were obtained from an external source.
- Fasting period before study: Food was withheld the night prior to dosing.
- Housing: - All housing and care· conformed to the standards established in the "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 environment controlled rooms.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: At least 5 days

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

On the first day of the study, animals received a single oral dose of 5000 mg/kg body weight of the test article.

Doses:

A single oral dose of 5000 mg/kg body weight of the test article.

No. of animals per sex per dose:

5/sex.

Control animals:

no

Details on study design:

Procedure
A range finding study was conducted to determine dose levels for the main study. Based on the results of the range finder, a limit test was conducted using ten animals.
Observations and Body Weights
Animals were observed frequently on the day of dosing and twice daily thereafter. Body weights were recorded initially, on day 8 and 15 or at death.

Necropsy
All animals that died during the study and those sacrificed at termination were subjected to a gross necropsy and abnormalities were noted.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived the 15 day post- dose observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the study, the oral LD50 for both male and female Sprague-Dawley rats has been determined to be greater than 5000 mg/kg bw.

Executive summary:

A study has been performed to determine the acute oral toxicity of the test material. The study has been conducted under GLP conditions and to OECD guidelines. The study has been given a Klimisch Score of 1.

The test material was dosed to five male and five female Sprague-Dawley rats at a level of 5000 mg/kg body weight. All animals survived the 15 day post- dose observation period. Based on the data obtained from this study, the acute oral LD₅₀is considered to be greater than 5000 mg/kg body weight. The test article is not considered to be toxic when administered by gavage to Sprague-Dawley rats.