1,3-diethyl-2-thiourea

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

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

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The acute oral toxicity of DETU was studied in male mice. Groups of 10 -20 mice were treated with DETU by gavage. The doses used were : 500, 700, 1000, 1400, 2000, 2800 mg/kg bw. A group of 10 mice wasn't treated, it was a control group. Animals were observed three hours after administration for clinical signs, and five days for mortality.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,3-diethyl-2-thiourea

EC Number:

203-308-5

EC Name:

1,3-diethyl-2-thiourea

Cas Number:

105-55-5

Molecular formula:

C5H12N2S

IUPAC Name:

1,3-diethyl-2-thiourea

Test animals

Species:

mouse

Strain:

CD-1

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River
- Age at study initiation: no data
- Weight at study initiation: 19-23g
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: gum arabic (10%)

Details on oral exposure:

Volume: 50 ml/kg

Doses:

500, 700, 1000, 1400, 2000, 2800 mg/kg bw

No. of animals per sex per dose:

10-20 mice/dose

Control animals:

yes

Details on study design:

Observation period: 5 days after administration

Statistics:

no

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

930 mg/kg bw

Mortality:

No mortality were observed in control group (0/10) and in 500 mg/kg group (0/10).
At 700 mg/kg bw: 5/20 mice died at 3 hours. At 1000 mg/kg bw: 5/20 mice died 3 hours after administration, then an other mouse diet at 1 day (6/20), and 4 mice at 2 days (10/20). At 1400, 2000 and 28000 : all mice died 3 hours or 1 day after administration.

Clinical signs:

other: Mice of control group did show any clinical signs. The mice treated with 500 mg/kg bw showed sedation and bradypnea. At 700 mg/kg bw, slow breathing, sedation and cyanosis were observed. At 1000, 1400, 2000 and 2800 mg/kg bw, the same symtoms that 700 mg/

Gross pathology:

no data

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

In this study, the oral LD50 of DETU was 930 mg/kg bw in male mice.

Executive summary:

The acute oral toxicity of DETU was studied in male mice. Groups of 10 -20 mice were treated with DETU by gavage. The doses used were : 500, 700, 1000, 1400, 2000, 2800 mg/kg bw. A group of 10 mice wasn't treated, it was a control group. Animals were observed three hours after administration for clinical signs, and five days for mortality.

No mortality and no clinical signs were observed at 0 and 500 mg/kg bw.

10/20 mice died at 700 mg/kg, and most of mice died at 1000, 1400, 2000 and 2800 mg/kg bw. Clinical signs observed in these animals were sedation, dyspnea, whrighting, tremor, hypothermia.

According these results, the LD50 of DETU was 930 mg/kg bw in male mice.