Tetramethylthiuram monosulphide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

tetramethylthiuram monosulfide

IUPAC Name:

tetramethylthiuram monosulfide

Constituent 2

Reference substance name:

Tetramethylthiuram monosulphide

EC Number:

202-605-7

EC Name:

Tetramethylthiuram monosulphide

Cas Number:

97-74-5

Molecular formula:

C6H12N2S3

IUPAC Name:

N,N-dimethyl[(dimethylcarbamothioyl)sulfanyl]carbothioamide

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Stamm Wistar TNO W 74, Züchter: Winkenmann, Borchen
- Age at study initiation: 9 week-old
- Weight at study initiation: 182 g
- Fasting period before study: no data
- Housing: 5 per cage
- Diet (e.g. ad libitum): Tiere Atromin R 1324, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-1.5°C
- Humidity (%): 60+/-5%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Lutrol

Details on oral exposure:

Volume of administration = 20 ml/kg

Doses:

100, 500, 1000, 2500, 3100 mg/kg

No. of animals per sex per dose:

10 rat/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice per day (one time the week end)
- Necropsy of survivors performed: no data

Statistics:

Probit analyse

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

690 mg/kg bw

Based on:

test mat.

95% CL:

360 - 1 060

Mortality:

At 100 mg/kg : no mortality (0/10)
At 500 mg/kg : 5/10 died animals
At 1000 and 2000 mg/kg : 7/10 died animals
At 2500 mg/kg: 8/10 died animals
At 3100 mg/kg: all animals died (10/10)

Clinical signs:

other: No clinical sign was observed at 100 mg/kg. Narcosis, diarrhea, shaggy coat, hair loss were observed at doses between 500 and 3100 mg/kg.

Gross pathology:

no data

Other findings:

no data

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

According to this study, the approximate acute oral rat LD50 is 690 mg/kg for male and female rats.

Executive summary:

Three groups of 10 male and 10 female rats were dosed at 100, 500, 1000, 2500 and 3100 mg/kg. The animals were observed for mortality, body weights and clinical signs though day 14.

No mortalities was observed at 100 mg/kg, 7 -8 animals died at 500, 1000 and 2500 mg/kg bw and all the animals died at 3100 mg/kg. Clinical signs at doses 500 -3100 mg/kg included narcosis, diarrhea, hair loss and shaggy coat ; a a decrease of bodyweight was observed. The dose of 100 mg/kg was asymptomatic.

According to this study, the approximate acute oral rat LD50 is 690 mg/kg for male and female rats.