2,6-di-tert-butyl-p-cresol

Acute Toxicity: oral

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

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Test material

Test material information

Constituent 1

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 or test system 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:

other: The substance did not cause any remarkable symptoms which were due to the applicated compound.

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.