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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of propan-2-ol and butan-1-ol and O-isopropyl ethylthiocarbamate
EC Number:
943-680-2
Molecular formula:
C6H13NOS
IUPAC Name:
Reaction mass of propan-2-ol and butan-1-ol and O-isopropyl ethylthiocarbamate
Test material form:
liquid
Details on test material:
EC Name: O-isopropyl ethylthiocarbamate
Isopropyl Ethyl Thionocarbamate
CAS Number:141-98-0
EC Number:205-517-7
Common name:Isopropyl Ethyl Thionocarbamate (IPETC)

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:
sligthly toxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute oral toxicity study with Isopropyl Ethyl Thionocarbamate (IPETC ) as a main constituent of Reaction mass of O-isopropyl ethylthiocarbamate and n-butanol and propan-2-ol in male rats, performed equivalent or similar to OECD 401 test guideline, an LD50 2324 mg/kg bw was determined.
Executive summary:

Isopropyl Ethyl Thionocarbamate (IPETC) 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 Isopropyl Ethyl Thionocarbamate (IPETC) as a main constituent of Reaction mass of O-isopropyl ethylthiocarbamate and n-butanol and propan-2-ol in male rats was established as 2324 mg/kg body weight and this show that Reaction mass of O-isopropyl ethylthiocarbamate and n-butanol and propan-2-ol is of a slightly order of acute oral toxicity according to EC regulation 1272/2008.