Carbonotrithioic acid, bis(phenylmethyl) ester

Acute Toxicity: oral

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:

other: GLP, OECD n°423 guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

460-390-7

EC Name:

-

Cas Number:

26504-29-0

Molecular formula:

C15H14S3

IUPAC Name:

bis(benzylsulfanyl)methanethione

Details on test material:

- Name of test material (as cited in study report): DIBENZYL TRITHIOCARBONATE
- Physical state: yellow orange-colored solid
- Analytical purity: 96.2
- Purity test date: 2003-10-27
- Lot/batch No.: 1 UG 114
- Expiration date of the lot/batch: November 2004
- Storage condition of test material: at room temperature and protected from light

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: approx. 8 weeks old
- Weight at study initiation: 281 ± 19 g for the males and 198 ± 4 g for the females
- Fasting period before study: yes (18 hours before administration)
- Housing: 3 rats of the same sex per polycarbonate cage (48x27x20cm)
- Diet (e.g. ad libitum): ad libitum A04C pelleted diet (U.A.R., 91360 Villemoisson sur Orge, France)
- Water (e.g. ad libitum): ad libitum drinking water filtered by a FG Millipore membrane (0.22µ)
- Acclimation period: > 5days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 2
- Humidity (%): 30-70
- Air changes (per hr): approx. 12
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 or 200 mg/ml
- Justification for choice of vehicle: solubility

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:

200 and 2000 mg/kg

No. of animals per sex per dose:

3/sex at 2000 mg/kg and 3 males at 200 mg/kg

Control animals:

no

Details on study design:

CLINICAL EXAMINATIONS
The single administration was performed in the morning of day 1; it was followed by a 14-day observation period.

Clinical signs and mortality:
The animals were observed frequently during the hours following administration of the test item, for detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day.
Type, time of onset and duration of clinical signs were recorded for each animal individually.

Body weight:
The animals were weighed individually just before administration of the test item on day 1 and then on days 8 and 15.
The body weight gain of the treated animals was compared to that of CIT control animals with the same initial body weight.

PATHOLOGY
Sacrifice:
On day 15, all animals were killed by carbon dioxide asphyxiation.

Macroscopic necropsy examination:
All study animals were subjected to a macroscopic examination as soon as possible after death.
After opening the thoracic and abdominal cavities, a macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed.

Preservation of tissues:
No organ samples were taken.

Statistics:

The interpretation of results was based on the flow charts of Annex 3 of the OECD Guideline No. 423, 22 March 1996.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Mortality:

No mortality was observed at 200 and 2000mg/kg

Clinical signs:

other: No clinical signs was observed in the animals given 200 mg/kg. At the 2000 mg/kg dose-level, no clinical signs were noted in males. In females, piloerection and dyspnea, together with hypoactivity and rhinorrea in 2/3 animals on day 1, were observed in al

Gross pathology:

Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008

Conclusions:

The oral LD0 of DIBENZYL TRITHIOCARBONATE is higher than or equal to 2000 mg/kg in rats.

Executive summary:

The acute oral toxicity of DIBENZYL TRITHIOCARBONATE was evaluated in rats according to OECD N°423 guideline (December 17^th2001).DIBENZYL TRITHIOCARBONATE was administered by oral route (gavage at 200 and 2000 mg/kg) to groups of 3 male and/or female fasted Sprague-Dawley rats.

No clinical signs and no mortality were observed in the animals given 200 mg/kg. At the 2000 mg/kg dose-level, no mortality occurred. No clinical signs were noted in males. In females, piloerection and dyspnea, together with hypoactivity and rhinorrea in 2/3 animals on day 1, were observed in all animals on days 1 and 2. The overall body weight gain of the animals given 200 mg/kg was not affected by treatment with the test item. The body weight gain of the males given 2000 mg/kg was slightly reduced during the first week of the study, when compared to historical control animals. The overall body weight gain of the females treated at 2000 mg/kg was similar to that of historical control animals. At necropsy, no apparent abnormalities were observed.

Under these experimental conditions, the oral LD0 of DIBENZYL TRITHIOCARBONATE in rat is higher than or equal to 2000 mg/kg in rats.