Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
(benzothiazol-2-ylthio)succinic acid
EC Number:
401-450-4
EC Name:
(benzothiazol-2-ylthio)succinic acid
Cas Number:
95154-01-1
Molecular formula:
C11H9NO4S2
IUPAC Name:
2-(1,3-benzothiazol-2-ylsulfanyl)butanedioic acid
Test material form:
solid
Details on test material:
(benzothiazol-2-ylthio)succinic acid, Batch: 1

Test animals

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.

Administration / exposure

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)

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:
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.

Applicant's summary and conclusion

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.