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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): BHT
- Source: Raschig AG, Postfach 21 11 28, 6700 Ludwigshafen
- Physical state: white crystalline powder

Test animals

Species:
rat
Strain:
other: SPF-Wistar rats, strain Winkelmann, Paderborn
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: mean body weights: 240 g for males and 215 g for females
- Fasting period before study: 16 hours before the test started, the animals were left without food.
- Housing: single cages
- Diet (e.g. ad libitum): Altromin, Lage, ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 ºC
- Humidity (%): 50-60%
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Tylose 0.25%
Details on oral exposure:
VEHICLE
- Concentration in vehicle: the test compound was diluted 30% in Tylose 0.25%
- Amount of vehicle (if gavage): All animals received 0.1 ml for dosage group 3000 mg/kg and 2.0 ml for dosage group 6000 mg/kg per 100 g of body weight.









Doses:
3000 and 6000 mg/kg
No. of animals per sex per dose:
4 animales per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly reports
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 6 000 mg/kg bw
Based on:
test mat.
Mortality:
Neither acute nor late mortalities occurred in any of the dosage groups.
Clinical signs:
The substance did not cause any remarkable symptoms which were due to the applicated compound.
Body weight:
There was no dose-related difference in weight gains after 14 days observation time.
Gross pathology:
No findings did occur in final autopsy and no pathological changes could be observed macroscopically.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The 24 -h LD50 was greater than 6000 mg/kg bw and after 14 days no late mortalities occurred. In the test dosages the substance did not cause any remarkable symptoms. In the final autopsy no clear anatomic-pathological changes occurred.
Executive summary:

BHT was tested in an acute toxicity study after one oral application on the rat. Groups of 4 rats per sex per dose was administered doses of 3000 and 6000 mg/kg bw. The 24 -h LD50 was greater than 6000 mg/kg bw and after 14 days no late mortalities occurred. In the test dosages the substance did not cause any remarkable symptoms. In the final autopsy no clear anatomic-pathological changes occurred.