O-isobutyl ethylthiocarbamate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

The study has been performed equivalent or similar to OECD 401 guideline and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

O-isobutyl ethylthiocarbamate

EC Number:

259-869-1

EC Name:

O-isobutyl ethylthiocarbamate

Cas Number:

55860-53-2

Molecular formula:

C7H15NOS

IUPAC Name:

O-isobutyl ethylthiocarbamate

Test material form:

liquid

Test animals

Species:

rat

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

Source: Ace Animals
- Age at study initiation: Not specified
- Weight at study initiation: 214 - 250 g
- Fasting period before study: 16 - 20 hours prior to dosing
- Housing: Individually in suspended cages
- Diet: Free access to Purina Rat Chow (diet #5012)
- Water: Free access to tap water.
- Acclimation period: At least 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature controlled
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

GAVAGE METHOD: syringe and dosing needle

Frequency: single

MAXIMUM DOSE VOLUME APPLIED: The dose was based on the sample weight as calculated from the specific gravity. The test substance was administered on g/kg basis.

DOSAGE PREPARATION: The test substance was used as recieved.

Doses:

2000,2500

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Animals were deprived of food 16 - 20 hours prior to dosing. Water was available ad libitum.

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing:
Mortality/Viability/Clinical signs: 1, 4 and 24 hours post dose and once daily thereafter for 7 days for mortality.
Body weights: Body weights were recorded pretest and at termination.
- Necropsy of survivors performed: not performed.
- Other examinations performed: none.

Statistics:

No statistical analysis was performed.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

2 324 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Physical signs of lethargy, ataxia, chromodacryorrhea, chromorhinorrhea, dyspnea, wetness of the anagenital area and soiling of the body area were noted during the observation period.

Mortality:

No mortality occurred.

Clinical signs:

Physical signs of lethargy, ataxia, chromodacryorrhea, chromorhinorrhea, dyspnea, wetness of the anagenital area and soiling of the body area were noted during the observation period.

Body weight:

All animals gained weight during the study.

Gross pathology:

No data.

Applicant's summary and conclusion

Interpretation of results:

other: sligthly toxic

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

In an acute oral toxicity study with Isobutyl Ethyl Thionocarbamate (IBETC ) in male rats, performed equivalent or similar to OECD 401 test guideline, an LD50 2324 mg/kg bw was determined.

Executive summary:

Isobutyl Ethyl Thionocarbamate (IBETC ) was administered by oral gavage in five male rats equivalent or similar to OECD 401 guideline and according to GLP principles. No mortality occurred. Physical signs of lethargy, ataxia, chromodacryorrhea, chromorhinorrhea, dyspnea, wetness of the anagenital area and soiling of the body area were noted during the observation period. All animals gained weight during the study. The oral LD50 value of Isobutyl Ethyl Thionocarbamate (IBETC ) in male rats was established as 2324 mg/kg body weight and this show that Isobutyl Ethyl Thionocarbamate (IBETC ) is of a slightly order of acute oral toxicity according to EC regulation 1272/2008.