O-isobutyl ethylthiocarbamate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

other: published data

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:

O-isopropyl ethylthiocarbamate (IPETC) is the similar substance as O-isobutyl ethylthiocarbamate (IBETC). Therefore, the health effects of O-isopropyl ethylthiocarbamate (IPETC) need to be considered in the assessment of O-isobutyl ethylthiocarbamate (IBETC).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

O-isopropyl ethylthiocarbamate

EC Number:

205-517-7

EC Name:

O-isopropyl ethylthiocarbamate

Cas Number:

141-98-0

Molecular formula:

C6H13NOS

IUPAC Name:

O-isopropyl ethylthiocarbamate

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): IPETC
- Physical state: liquid
- Stability under test conditions: stable
- Storage condition of test material: ambient

Test animals

Species:

rabbit

Strain:

other: New Zealand Albino rabbits

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: 2.2 - 2.5 kg
- Housing: Individually in suspended cages.
- Diet: Free access to Purina Rabbit Chow (Diet #5321)
- Water: Free access to tap water.
- Acclimation period: At least 3 days

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

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Prior to application of the test substance, the dorsal area of each animal was clipped free of hair. The prepared site was approximately 10% of the body surface and remained intact.

The test substance was covered with a gauze patch which was secured with non-irritating adhesive tape. The torso was wrapped with plastic which was held in place with non-irritating tape.

Frequency: Single dosage, on Day 1.

Washing: No, following application, wrappings were removed and the sites were wiped.

Duration of exposure:

24 hours.

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

DOSAGE PREPARATION: The test substance was used as received, measured by syringe and applied to the prepared site.

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:

None.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

One animal exhibited yellow nasal discharge on the day of dosing and on day 1. At all other times, all animals appeared normal during the observation period.

Body weight:

Body weight changes were normal.

Gross pathology:

No data.

Any other information on results incl. tables

A single dose of 2 000 mg/kg of the notified chemical was administered by semi-occlusive application to the shaved skin of New Zealand Albino rabbits (5 males) for 24 hours. The animals were observed at 1, 4 and 24 hours after dosing and subsequently once daily for 7 days after removal of the bandage. No deaths were noted during the study. All animals showed expected gain in body weight during the study. One animal exhibited yellow nasal discharge up to day one. All animals showed slight to moderate erythema and oedema. Necropsy findings were not recorded in the study. The results of this study indicate a dermal LD50 of > 2 000 mg/kg for the notified chemical in male rabbits.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

In an acute dermal toxicity study with Isopropyl Ethyl Thionocarbamate (IPETC) performed to OECD 402 test guideline, an LD50 >2000 mg/kg bw was determined.
O-isopropyl ethylthiocarbamate (IPETC) is the similar substance as O-isobutyl ethylthiocarbamate (IBETC). Therefore, the health effects of O-isopropyl ethylthiocarbamate (IPETC) need to be considered in the assessment of O-isobutyl ethylthiocarbamate (IBETC).

Executive summary:

Isopropyl Ethyl Thionocarbamate (IPETC ) was administered to five male New Zealand Albino rabbits by a single dermal occlusive application at 2000 mg/kg bw equivalent to OECD 402 guideline and according to GLP principles. No mortality occurred. One animal exhibited yellow nasal discharge on the day of dosing and on day 1. At all other times, all animals appeared normal during the observation period. Body weight changes were normal.

The dermal LD50 value of Isopropyl Ethyl Thionocarbamate (IPETC ) in rabbits was established to exceed 2000 mg/kg body weight. O-isopropyl ethylthiocarbamate (IPETC) is the similar substance as O-isobutyl ethylthiocarbamate (IBETC). Therefore, the health effects of O-isopropyl ethylthiocarbamate (IPETC) need to be considered in the assessment of O-isobutyl ethylthiocarbamate (IBETC).