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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:
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

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male
Details on test animals 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:
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/kg bw were observed with tremor, whrighting and hypothermia
Body weight:
no data
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.