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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
Study period:
1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa Credo, Brussel, Belgium
- Young animals
- Weight at study initiation: 281.9 +-7 (male)/ 208.8+-8 (female)
- Fasting period before study: 12 hours before, and 4 hours after gavage
- Housing: individually in Macrolon cages
- Diet and water ad libitum
- Acclimation period: 6 days
- Quarantine period of 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 25-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
5.405 mL/Kg
Doses:
5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Preliminary study:
Dose range finding study with one male and one female, at following doses: 1800, 2400, 3200, 4200, 5000 mg/kg : no mortality, no clinical signs excepted diarrhea, no gross abnormalities at necropsy.
Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.
Mortality:
no
Clinical signs:
diarrhea for 9 animals the two first days
Body weight:
male: mean body weight at day 0: 281.9 +-7 g; at day 7: 326.0+-13.3; at day 14: 366.2 +-13.6
female: mean body weight at day 0: 208.8+-8.8; at day 7: 235.6 +-14.4; 251.7+-22.8
Gross pathology:
no effect

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD0 of TBEC more than 5000 mg/kg in Sprague Dawley rats.
Executive summary:

The Acute oral toxicity of TBEC was evaluated in rats according to OECD N°401 guideline (Acute Toxic Standard Method). Groups of 5 male and 5 female Sprague Dawley rats were given a single oral dose of 5000 mg/kg. Following treatment, rats were observed daily and weighted weekly. A gross necropsy examination was performed at the time of scheduled euthanasia (Day 14).

There was no mortality. Excepted diarrhea among most animals in the beginning of the study, no systemic toxicity was reported Body weight gain was normal. Macroscopic examination at necropsy revealed no gross abnormalities.

Under these experimental conditions, the oral LD0 of TBEC was higher than 5000 mg/kg in Sprague Dawley rats.