3-iodo-2-propynyl butylcarbamate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984-04-27 to 1984-07-13

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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)

Version / remarks:

1981

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-iodo-2-propynyl butylcarbamate

EC Number:

259-627-5

EC Name:

3-iodo-2-propynyl butylcarbamate

Cas Number:

55406-53-6

Molecular formula:

C8H12INO2

IUPAC Name:

3-iodoprop-2-yn-1-yl butylcarbamate

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: stored at room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Kingston, New York
- Weight at study initiation: initial body weights did not exceed 20 % of mean body weights
- Fasting period before study: overnight
- Housing: individually in suspended wire-mesh cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: approx. one week

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: as appropriate
- Lot/batch no.: 52500

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

250; 500; 1000; 1500; 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: observation at one, two, and four hours post treatment, and once daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology

Statistics:

The mortality data were analyzed separately for males by a modified Behrens-Reed-Muench Cumulant Method (Thakur and Fezio, 1981). For the females and for the sexes combined. LD50´s and their 95 % confidence intervals were computed using a maximum likelihood Logit Method (Bliss, 1952).

Results and discussion

Preliminary study:

The Group 2 (1000 mg/kg bw) animal was found dead on Day 2 postdose; the Group 3 (1500 mg/kg bw) animal at 4 hours; the Group 4 (2000 mg/kg bw) animal on Day 3; and the Group 5 (2500 mg/kg bw) animal was found dead on Day 2. Clinical observations included rough coat in all groups; soft feces and urine stains in all treatment groups, except Group 3; slight depression and/or depression in Groups 2, 3, 4 and 5; and red stains on the nose and/or eyes and hunched appearance in Group 4. Animals in Groups 3, 4, and 5 lost weight between initiation and death. The Group 2 animal gained weight.
All surviving animals had no observable gross pathology findings at necropsy. In the animals which were found dead, gross pathology findings were noted for the lung, stomach, intestines, and liver.

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

1 795 mg/kg bw

Based on:

test mat.

95% CL:

> 1 437 - < 2 243

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

1 056 mg/kg bw

Based on:

test mat.

95% CL:

> 783 - < 1 329

Effect levels 3

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 470 mg/kg bw

Based on:

test mat.

95% CL:

> 1 226 - < 1 713

Clinical signs:

other: Clinical observations included soft feces, rough haircoat, urine stains, and slight depression and/or depression in all groups; ataxia, hunched appearance and prostration in Groups 3, 4 and 5; labored respiration in Group 3 and 4; and tremors in Group 5.

Gross pathology:

All surviving animals had no observable gross pathology findings at necropsy. In the animals which were found dead, gross pathology findings were noted for the stomach, intestine, kidneys, and liver.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

LD50 of the test item for acute oral toxicity is determined to be 1056 mg/kg bw for female Sprague Dawley rats.

Executive summary:

The test item was evaluated for acute oral toxicity in male and female rats. Based upon the findings of this study, the acute oral LD50 in males was calculated to be 1795 mg/kg bw, with 95 % confidence limits of 1437 and 2243 mg/kg bw; the oral LD50 in females was calculated to be 1056 mg/kg bw, with 95 % confidence limits of 783 and 1329 mg/kg bw; and the combined LD50 in males and females was calculated to be 1470 mg/kg bw, with 95 % confidence limits of 1226 and 1713 mg/kg bw.