Thiophanate-methyl

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 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 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

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:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Japan, Inc. (Atsugi, Kanagawa, Japan)
- Age at study initiation: 7 weeks old
- Weight at study initiation: 221.4 ± 2.2 g in males and 161.0 ± 10.2 g in females at administration
- Housing: Group-housed (5 animals per cage) in stainless steel mesh cage (W 21 xD 40 xH 19cm)
- Diet: Pelleted diet, MF(Oriental Yeast Co., Ltd., Tokyo), access to the food was prevented overnight before and 3 hours after the administration
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.4 ± 0.2
- Humidity (%): 62.6 ± 2.4
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Amount of vehicle : 10 mL/kg bw

Doses:

5000 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: Animals were observed for 1 hour and at 3 hours after the administration and thereafter at least once a day (except holidays). The animals were weighed prior to the administration 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:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No death was found in any rats. The oral LD50 values were determined as more than 5000 mg/kg in both sexes.

Clinical signs:

other: No clinical signs were observed in any rats of either sex.

Gross pathology:

No abnormality was observed in any rats of either sex.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 was determined to be > 5000 mg/kg bw in rats.

Executive summary:

An acute oral toxicity study was performed in rats. The study was performed as GLP study similar to OECD guideline 401. Five rats/sex received a single oral gavage treatment with the test item in distilled water at 5000 mg/kg bw (10 mL/kg bw) and were then observed for 14 days. Animals were observed for 1 hour and at 3 hours after the administration and thereafter at least once a day (except holidays). Clinical signs were recorded at each observation. The animals were weighed prior to the administration and after 1, 2, 3, 7 and 14 days. A gross necropsy was performed at the termination of the experiment. All the rats were anesthetized with chloroform and sacrificed. No mortality, clinical signs or unusual changes in body weight were observed. Gross necropsy revealed no abnormality in any rats of either sex. The acute oral LD50 was determined to be > 5000 mg/kg bw.