Thiophanate-methyl

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 May 1990 - 23 August 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Thiophanate-methyl

EC Number:

245-740-7

EC Name:

Thiophanate-methyl

Cas Number:

23564-05-8

Molecular formula:

C12H14N4O4S2

IUPAC Name:

methyl N-{[2-({[(methoxycarbonyl)amino]methanethioyl}amino)phenyl]carbamothioyl}carbamate

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

other: Kbs:JW (Japanese-white)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kitayama LABES Co., Ltd. (Kyoto, Japan)
- Age at study initiation: 11 weeks old in male and female at the application
- Weight at study initiation: 2466.0±161.9 g in males and 2447.4±149.9 g in females at the application
- Housing: individually in stainless steel mesh cages (W 35xD 50xH 35cm)
- Diet: pelleted diet, RC-4 (0riental Yeast Co., Ltd., Tokyo), ad libitum
- Water: tap water, ad libitum
- Acclimation period: Quarantine: 13 days prior to the application.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.9± 0.6
- Humidity (%): 64.0± 1.7
- Air changes (per hr): 18
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: The test item was spread on a piece of lint (12 x 14 cm) which was applied to the back of the animal.
- Type of wrap: elastic bandage (Elascot, TE-1902, Tokyo Eizai Lab. Co., Ltd.)

REMOVAL OF TEST SUBSTANCE
- Washing: the application site was washed with water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amounts applied: male: 27.1 - 31.0 mg/cm2, female: 28.0 - 30.4 mg/cm2
- For solids, paste formed: no

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes, concurrent no treatment

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: 1 hour and at 3 hours after the application and thereafter at least once a day (except holidays); weighing: prior to the application and after 1, 2, 3, 7 and 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No death was found in any rabbits.

Clinical signs:

other: 4 males and 3 females in the dosed groups showed reddening of the application area. This sign continued for 2 days after the application.

Gross pathology:

No abnormality was observed in any rabbits of either sex.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal LD50 was determined to be > 2000 mg/kg bw.

Executive summary:

An acute dermal toxicity study was performed with the test item in Kbs:JW rabbits. Twenty animals were divided into 1 control and 1 dose group consisting of 5 rabbits in each sex. The test item was dermally applied to the animals of the dose group at 2000 mg/kg bw and the animals of the control group were treated the same manner as the animals of the dosed group except for the test substance application. 4 males and 3 females in the dose group showed reddening of the application area. This observation continued for 2 days after the application. Body weight was not affected by the treatment. No death was observed in any rabbits of either sex. No abnormality on necropsy was observed in any rabbits. The acute dermal LD50 was determined to be > 2000 mg/kg bw.