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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
7 Nov - 19 Dec 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted in 1987
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Disulfiram
EC Number:
202-607-8
EC Name:
Disulfiram
Cas Number:
97-77-8
Molecular formula:
C10H20N2S4
IUPAC Name:
disulfiram

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Shizuoka Agricultural Cooperative Association for Experimental Animals, Shizuoka
- Age at study initiation: 7 weeks
- Weight at study initiation: Male 240-270 g, Female 200-220 g
- Housing: 10 animals/ cage
- Diet: CE-2 Type (Nihon Clea Co., Osaka), ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 1°C
- Humidity (%): 60 ± 10%

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
corn oil
Doses:
500, 650, 845, 1000, 1300, 1700, 2200, 2860, 3850 and 5000 mg/kg bw
No. of animals per sex per dose:
10 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
Statistics:
No data

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
1 860 mg/kg bw
Based on:
test mat.
95% CL:
1 510 - 2 290
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
2 090 mg/kg bw
Based on:
test mat.
95% CL:
1 960 - 2 480
Mortality:
At 1000 and above: Death was found in 1-7 days post-treatment.

Mortalities were:
- 500 mg/kg bw: 0/10 males, 0/10 females
- 650 mg/kg bw: 0/10 males, 0/10 females
- 845 mg/kg bw: 0/10 males, 0/10 females
- 1000 mg/kg bw: 1/10 males, 1/10 females
- 1300 mg/kg bw: 2/10 males, 1/10 females
- 1700 mg/kg bw: 3/10 males, 2/10 females
- 2200 mg/kg bw: 8/10 males, 4/10 females
- 2860 mg/kg bw: 10/10 males, 10/10 females
- 3850 mg/kg bw: 10/10 males, 10/10 females
- 5000 mg/kg bw: 10/10 males, 10/10 females

Summarized results can be found in Attachment 1 in the attached background material.
Clinical signs:
other: At 500 mg/kg: No toxic symptoms were seen. At 650 and 845 mg/kg: Only slight motor ataxia was observed. At 1000 and above: Decrease of spontaneous motor activity, piloelection, irregular respiration and dyspnea were developed 3-4 hours after administratio
Body weight:
other body weight observations
Remarks:
not examined
Gross pathology:
No remarkable changes were found in any animals of each group.

Any other information on results incl. tables

Sex difference was not seen.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The study was conducted similar to OECD guideline 401. The LD50 for female rats was 2090 mg/kg bw, the LD50 for male rats was 1860 mg/kg bw. Based on the LD50 in males, the substance should be classified for acute oral toxicity category 4 (Acute Tox. 4, H302) according to the Regulation (EC) 1272/2008.