(benzothiazol-2-ylthio)succinic acid

Endpoint summary

Description of key information

The LD50 value of the test item was above 5000 mg/kg bw, the highest concentration tested (CIBA-GEIGY, Ltd., 1984).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 16,1984 - May 30, 1984; Report June 12, 1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

This test has been put under QA surveillance by the QAU

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif X RII 2/Tif

Sex:

male/female

Details on test animals or test system and environmental conditions:

Number of Animals Per Dose Level: 5 males and 5 females
Total Number of Animals: 10

Source:
CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland

Initial Body Weight Range :
164-229 g

Initial Age:
7-8 weeks

Individual Identification:
by colour code using picric acid

Husbandry:
The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding (Societe Parisienne des sciures, Pantin) . The animal room was air conditionned: temperature 22+3° C, relative humidity 55±15%, 12 hours light/day, approximately 15 air changes/h.

Diet:
Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland), and water were provided ad libitum.

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Administration: oral, by gastric intubation (gavage)
Vehicle: Distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80
Dose Level: 5000 mg/kg bw.
Volume (ml/kg body weight) applied: 20
Administration of the Test Article: one single dose, per os

The animals were allocated to the different dose groups by random selection.
Prior to dosing, the animals were fasted overnight.

Doses:

Dose Level: 5000 mg/kg bw.

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

Duration of observation period following administration: 14 days

Mortality: daily; a.m. and p.m. on working uays, a.m. on weekend days
Signs and Symptoms: daily
Body weight: on days 1, 7, 14 and at death
Necropsies: Spontaneously dying animals were submitted to a gross necropsy as soon as possible; survivors at the end of the observation period.

Statistics:

From the body weights, the group means and their standard deviations were calculated.
Where feasable, the LDSO including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944)

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed at a concentration of 5000 mg/kg bw.

Clinical signs:

other: Dyspnoea, exophthalmus, ruftled fur, and curved body position were seen. The surviving animals recovered within 10 days.

Gross pathology:

No gross lesions were found at necropsy.

Conclusions:

The test item has practically no acute toxicity when administered orally to the albino rat. LD 50 > 5000 mg/kg/bw

Executive summary:

In an acute toxicitystudy according to OECD Guideline No. 401, 5 male and 5 female albino rats were exposed to 5000 mg/kg/bw after oral administration.

Upon an acute oral administration and a 14 day post-treatment observation period, the following LD50 was determined for the test item.

LD50 in male rats; >5000 mg/kg bw.

LD50 in female rats; >5000 mg/kg bw

LD5O in rats of both sexes; > 5000 mg/kg bw

The test item has practically no acute toxicity when administered orally to the albino rat.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Quality of whole database:

The study was conducted following an accepted guideline with acceptable restrictions (Klimisch 2).

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the results of the acute oral study and according to the criteria of EC Regulation 1272/2008 the test item has practically no acute toxicity if swallowed (LD50 (rat) > 5000 mg/kg bw). Therefore, the test substance must not be classified.