(benzothiazol-2-ylthio)acetic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985-05-22 to 1985-06-26

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: All scientific necessary information for evaluation is available. Only the translation of the study report is available. The study was performed according to OECD guideline 401.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

Not mentioned in report

Deviations:

not specified

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

(benzothiazol-2-ylthio)acetic acid

EC Number:

228-565-0

EC Name:

(benzothiazol-2-ylthio)acetic acid

Cas Number:

6295-57-4

Molecular formula:

C9H7NO2S2

IUPAC Name:

2-(1,3-benzothiazol-2-ylsulfanyl)acetic acid

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Praeparat EK, Acetic acid (2-benzothiazolylthione)
- Physical state: solid, powder
- Analytical purity: 100%
- Impurities (identity and concentrations): n.a.
- Lot/batch No.: n.a.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5% Methylcellulose 400 cps

Doses:

First trial: 1500, 2000 and 2500 mg/kg bw and
Due to mortalities seen with the first three dose levels, additional three dose levels were tested : 1000, 3000, 500 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

The test started with three dose levels: 1500, 2000 and 2500 mg/kg bw
Due to mortalities seen with the first three dose levels, additional three dose levels were tested : 1000, 3000, 500 mg/kg bw. Gross pathology was investigated at all animals that died during the observation period as well as at all surviving animals at termination of observation period.

Statistics:

according to method published by J. Litchfield and F. Wicoxon (J. Parmacology, 1949, 95-99)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 580 mg/kg bw

Based on:

test mat.

95% CL:

> 1 405 - < 1 776

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of above mentioned study the median lethal dose (LD50) of the test substance after single oral administration to male and female rats, observed over a period of 14 days is 1580 mg/kg bw.

Executive summary:

A study was performed to determine the acute oral median lethal dose (LD50) of the test material, administered per oral gavage as a solution in 0.5% methyl cellulose 400 cps in the Sprague-Dawley strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 401 "Acute Oral Toxicity" referenced as EU Method B.1 (Acute Toxicity (Oral)).

Ten fasted animals per dose group (five per sex) were given a single oral dose of test material at dose levels of 1500, 2000 and 2500 mg/kg bw. Mortality occurred between 2 hours and 6 days after treatment. Due to mortalities seen in each dose group additional three dose levels ( i.e. 500, 1000, 3000 mg/kg bw) were tested in rat groups of 5 females and 5 males per dose thereafter. At 3000 mg/kg bw dose level 5 females and 5 males died within 2 days after treatment. At 1000 mg/kg bw dose 2 females and one male died within 7 days. At the 500 mg/kg bw dose group no mortality occurred. Clinical signs observed at all treated animals during the first 24 hours after treatment were hypoactivity. Some of the rats that died between day 5 and 7 after application appeared cachectic. Necropsy of the animals that died during the study period revealed hyperemia and/or erosion and/or haemorrhagic ulceration of the mucosa of the stomach. No abnormalities were noted at all surviving animals that were killed at end of study period.

Based on the results of above mentioned study, the median lethal dose (LD50) of the test substance after single oral administration to male and female rats, observed over a period of 14 days is 1580 mg/kg bw.