3-iodo-2-propynyl butylcarbamate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991-11-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-2 (Acute Dermal Toxicity)

Version / remarks:

1984

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

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:

SOURCE OF TEST MATERIAL
- lot/batch No.of test material: 9106-6269

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Eastern Rabbit Breeding Laboratory, Taunton, MA)
- Age at study initiation: 10-12 weeks old
- Weight at study initiation: 2000 - 3000 g
- Housing: individually in suspended stainless steel cages. Hardwood chips were used as non-contact bedding under the cages.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 4 days of quarantine

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 1.5 °C
- Humidity: 30 - 70 %
- Air changes: min. 10 - 13 per hr
- Photoperiod: 12 / 12 hrs dark / hrs light

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: trunk
- % coverage: approx. 10 % of body surface
- Type of wrap if used: Vetrap impervious bandaging

REMOVAL OF TEST SUBSTANCE
- Washing: skin was gently wiped and rinsed with USP water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 2000 mg/kg bw
- For solids, paste formed: no; gauze patches were moistened with physiological saline

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation for clinical signs; weighing at the beginning and end of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

not applicable

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No animal died during the 14 day observation period following treatment.

Clinical signs:

other: There were no overt signs of toxicity noted in any test animal during the observation period.

Gross pathology:

No findings

Other findings:

Skin reactions:
Erythrema (scores 1 and 2) was noted on 10/10 animals, on Day 1. Erythrema was reversed in all animals by Day 2. No signs of Edema was noted on any animal during the observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is considered non-toxic in rabbits, at a dose of 2000 mg/kg bw by dermal application, based upon the absence of mortality and criteria set forth by FIFRA.

Executive summary:

The test item was evaluated for its potential to produce systemic toxicity or death following topical application at a dose of 2000 mg/kg bw in male and female New Zealand White albino rabbits. Based on the absence of moratlity and the criteria of the study protocol, the test substance is defined as non-toxic via the dermal route. It should be noted that erythrema (score 1 and 2) were observed in 10/10 animaly at Day 1, which were fully reversible at Day 2.