Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Remarks:
White solid
Details on test material:
The test substance is identified as 1,1'-[ethane-1,2-diylbis(thio)]bisbenzene. The purity is 100%. The physical state/appearance of material is white solid. The expiry date of material is 13 February 2019. The substance can be stored at room temperature in the dark conditions.
Specific details on test material used for the study:
1,1'-[ethane-1,2-diylbis(thio)]bisbenzene (100% purity) as a solution/suspension in arachis oil BP.

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
Female Wistar strain rats were acclimatization period of at least 5 days the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card. At the start of the study the animals were 8 to 12 weeks of age. The body weight variation did not exceed ±20% of the mean body weight at the start of treatment.


The animals were housed in groups ofup to four in suspended solid-floor polypropylene cages furnished with woodflakes. The temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70% respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness and free access to mains drinking water and food.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted body weight at the time of dosing. dose volume of 10 ml/kg was given to each animal.
Doses:
300 and 2000 mg/kg
Details on study design:
A total of five animals were therefore treated at a dose level of 300 mg/kg in the study and 1 animals for 2000 mg/kg group.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
300 - 2 000 mg/kg bw
Based on:
test mat.
Mortality:
The animal treated at a dose level of 2000 mg/kg was killed for humane reasons, 1 day after dosing, due to the occurrence of clinical signs of toxicity.There were no deaths at a dose level of 300 mg/kg.
Clinical signs:
Signs of systemic toxicity noted in the animal treated at a dose level of 2000 mg/kg were clonic convulsions, exophthalmos, increased salivation, dehydration, pilo-erection and decreased respiratory rate. There were no signs of systemic toxicity noted at a dose level of 300 mg/kg.
Body weight:
Surviving animals showed expected gains in body weight.
Gross pathology:
Abnormalities noted at necropsy of the animal treated at a dose level of
During necrospsy at dose level of 2000 mg/kg were patchy pallor of the liver, epithelial sloughing of the gastric mucosa and hemorrhage of the non-glandular epithelium of the stomach. No abnormalities were noted at necropsy of animals treated at a dose level of 300 mg/kg.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg body weight (Globally Harmonized Classification System - Category 4).
Executive summary:

The study was performed to assess the acute oral toxicity of the 1,1'-[ethane-1,2-diylbis(thio)]bisbenzene in the Wistar rats. The study was conducted in accordance to  OECD test Guideline No 420 "Acute Oral Toxicity - Fixed Dose Procedure"(2001). Dose levels of 2000 mg/kg and 300 mg/kg were given as a single oral dose of test item, as a solution in arachis oil. The animal treated at a dose level of 2000 mg/kg was killed for humane reasons, 1 day after dosing, due to the occurrence of clinical signs of toxicity. There were no deaths at a dose level of 300 mg/kg. The clinical signs were observed at 2000 mg/kg dose levels were clonic convulsions, exophthalmos, increased salivation, dehydration, pilo-erection and decreased respiratory rate. The surviving animals showed expected gains in body weight. Oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg body weight (Globally Harmonized Classification System - Category 4).