Propargite

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12th August 1991 to 26th August 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPP 81-2 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OTS 798.1100 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 3

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Propargite

EC Number:

219-006-1

EC Name:

Propargite

Cas Number:

2312-35-8

Molecular formula:

C19H26O4S

IUPAC Name:

propargite

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): Omite® Technical
- Stability under test conditions: at least one year at room temperature
- Storage condition of test material: sealed container at room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazelton Research Products, Inc., Denver, Pennsylvania, USA
- Age at study initiation: young adult
- Weight at study initiation: 2097-2231 g
- Housing: individual suspended mesh-bottom cages
- Diet: Purina® Certified Rabbit Chow® #5322 ad libitum
- Water: tap water ad libitum
- Acclimation period: a minimum of 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 67-76 ºF
- Humidity: 62-80 %
- Photoperiod: 12 hours light/12 hours dark

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- % coverage: approximately 23 %
- Type of wrap if used: gauze binders

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3.7 mL/kg

Duration of exposure:

24 hours

Doses:

4000 mg/kg bw

No. of animals per sex per dose:

Five

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality and clinical observations at 1, 3, 4 hours post-dose and thereafter twice daily; dermal observations approximately 30-60 minutes after bandage removal and daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: body weights on days 0, 7 and 14

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: Abnormal defecation was generally noted during the first week post treatment. Loss of appetite was noted for six animals, while scabbing/swelling around the mouth and dry yellow staining around the nose were observed for eight animals. By the end of the s

Gross pathology:

The only finding on necropsy was reddened lungs in a single male.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified in accordance with EU criteria

Conclusions:

The acute dermal LD50 of the test material in rabbits is greater than 4000 mg/kg.

Executive summary:

The test material was administered once dermally at a dose of 4000 mg/kg to the shaved intact skin of five male and five female albino rabbits for a 24 hour period under semi-occlusive dressing. Mortality, clinical observations, dermal findings, body weights and gross necropsy findings were evaluated.

There were no deaths or remarkable body weight changes during this study.

Two animals vocalised at the time of bandage and test material removal. Abnormal defecation was generally noted during the first week of the study. Inappetence was observed early in the study for six animals. Scabbing and swelling around the mouth and dry yellow staining around the nose were each noted for eight animals during the second week of the study. One animal had wet yellow urogenital staining. Four animals appeared normal by study termination or earlier.

The test material induced severe erythema and edema on all animals. Additional dermal observations generally appeared during the second week of the study and persisted through to study termination. These findings included eschar, white-yellow areas present within the application site, fissuring and desquamation for all animals. Six animals had white-yellow exudate on the application site. Exfoliation was observed on four sites late in the study.

Thickened skin and desquamation within the application site were noted for all animals at terminal necropsy. One animal had reddened lungs. There were no other remarkable gross necropsy findings.

The LD₅₀ value was found to be greater than 4000 mg/kg.