S-2-Benzothiazolyl (Z)-2-(2-aminothiazol-4-yl)-2-acetyloxyiminothioacetate

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: A study according to the EU and OECD methods, including GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

457-660-1

EC Name:

-

Cas Number:

104797-47-9

Molecular formula:

C14H10N4O3S3 (Hill formula) C14H10N4O3S3 (CAS Formula)

IUPAC Name:

(Z)-[1-(2-amino-1,3-thiazol-4-yl)-2-(1,3-benzothiazol-2-ylsulfanyl)-2-oxoethylidene]amino acetate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Name: T15-AE
Chemical name: syn-2-(2-Aminothiazol-4-yl)-2-(methylcarbonyloximino) aceticacid-mercaptobenzthiazolylester.
Supplier: Sponsor.
Batch No.: PBi 5/184.
Molecular formula: C14 H10 N4 O3 S3.
Appearance: Yellow powder.
Purity: 96.8 % (HPLC)
Conditions of storage: In the deep freezer, in the dark; may be used under light.
Stability at conditions of storage: 12 months.
Stability at room temperature: Ca. 2 weeks.
Expiry date: October 2003
pH: 8.1 of a 1 % suspension in water.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland.
- Age at study initiation: Ca. 8 w.
- Weight at study initiation: 169 - 209 g
- Fasting period before study: From the evening before dosing to 3 h after dosing.
- Housing: Single caging
- Diet: Altromin 1324 forte, gamma-irradiated, ad libitum
- Water: Tap water ad libitum
- Acclimation period: At least 5 d.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 22
- Humidity (%): ca. 49
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

A peroral administration was performed once in the morning by stomach intubation using a metal gavage.
The dose volume was 20 mL per kg body weight. The individual dose volumes were calculated using the body weights determined on the day of the administration. The test substance was suspended in 0.1 % CMC.

Doses:

2000 mg/kg bw.

No. of animals per sex per dose:

3 rats per step.

Control animals:

no

Details on study design:

The sequence of dosing of the test substance was:
Step 1: 2000 mg/kg bw.
Step 2: 2000 mg/kg bw.

Statistics:

No.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Mortality: All animals survived until the scheduled termination of the study.

Clinical signs:

Observations in life. All animals were normal during the whole observation period.

Body weight:

Body weights: All animals gained weight in both weeks p.a.

Gross pathology:

Necropsy findings: No abnormal findings were made in all animals at the necropsy 14 d p.a.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No toxic effects of the test substance were noted by signs in life and post mortem at a dose of 2000 mg test substance per kg body weight. No mortality occurred.

Executive summary:

The acute toxic class (ATC) method according to the OECD-guideline was applied to investigate the acute oral toxicity of the substance in rats. Two steps with a dose of 2000 mg/kg bw were performed.

No toxic effects of the test substance were noted by signs in life and post mortem at a dose of 2000 mg test substance per kg body weight. No mortality occurred. The oral LD50 was determined to >2000 mg/kg body weight.