Carbamic acid, N-butyl-, 2-propyn-1-yl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997-02-17 to 1997-05-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well documented GLP based study in accordance to EPA standard guideline

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1175 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-propynyl-butylcarbamate

EC Number:

616-291-8

Cas Number:

76114-73-3

Molecular formula:

C8H13NO2

IUPAC Name:

2-propynyl-butylcarbamate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): only common name based on sponsor informaion is given, equivalent to:
Chemical name: Carbarmic acid, N-butyl-,2-propyn-1-yl ester
CAS: 76114-73-3

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Inc., in Boyertown, PA
- Age at study initiation: approximately 6 to 10 weeks
- Weight at study initiation: 208 to 234 g
- Fasting period before study: yes for 18 hours
- Housing: stainless steel cages with indirect bedding
- Diet: ad libitum: Lab Diet Certified Rodent Diet 5002
- Water: ad libitum
- Acclimation period: 8 days prior to test initiation

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.3 -23.8 °C (65° to 75° F)
- Humidity (%): humidity was monitored
- Photoperiod (hrs dark / hrs light):12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- test item was used as received for the initial dose (group 1: 2000 mg/kg bw)

Administration volume: 2 ml/kg bw.

Doses:

group 1: initial dose (= limit dose): 2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed at 1,3,6 and 24 hours post-dosage and daily thereafter for at total of 14 days. Bodyweights were recorded on day 7 after exposure and at termination of the study.
- Necropsy of survivors performed: yes ( also any non-survivors)
- Sacrificing: with carbon dioxide asphyxiation
- Other examinations performed: clinical signs, body weight, histopathology

Statistics:

-no special statistics applied

Results and discussion

Preliminary study:

At the initial dose of 2000 mg/kg bw 4/5 males and 5/5 females died on day 2 to day 4 after exposure. All animals suffered depressions before.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

< 2 mg/kg bw

Based on:

test mat.

Mortality:

2000 mg/kg bw: 80% mortality males and 100 % females (rats died on day 2 to 4 after exposure)

Clinical signs:

other: 2000 mg/kg bw: All rats showed slight or severe depressions on day 2 and 3 after exposure and before dead; one survivor did not show any clinical signs after day3 of exposure. Also diarrhea and muscle tremors have been observed. 1 g/kg bw: All rats showe

Gross pathology:

The small intestine of rats appeared severely reddened and sometimes ulcerated.

Applicant's summary and conclusion

Conclusions:

According to the guideline, the oral LD50 of Propargyl-N-butylcarbamat is less than 2000 mg/kg bw.

Executive summary:

The acute oral toxicity of Propargyl-N-butylcarbamat

was determined in rats according to the EPA guideline OTS 798.1175. The LD50 was found to be smaller than the limit dose of 2000 mg/kg bw.