N-(tert-butyl)benzylamine

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

Justification for type of information:

Guideline study under current quality assurance processes.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-(tert-butyl)benzylamine

EC Number:

222-179-6

EC Name:

N-(tert-butyl)benzylamine

Cas Number:

3378-72-1

Molecular formula:

C11H17N

IUPAC Name:

N-(tert-butyl)benzylamine

Test material form:

liquid

Details on test material:

Distilled NBTB, N-Benzyl-tert-butylamine; N-(1,1-dimethylethyl) benzene-methanamine. Purity 99.3% (average). Liquid. Store at room temperature.

Specific details on test material used for the study:

Distilled NBTB, N-Benzyl-tert-butylamine; N-(1,1-dimethylethyl) benzene-methanamine. Purity 99.3% (average). Liquid.

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River UK Ltd., Margate, Kent, England
- Females (if applicable) nulliparous and non-pregnant: no data
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 106-149 g
- Fasting period before study: no data
- Housing:metal cages with wire mesh floors
- Diet (e.g. ad libitum): Lab Sure LAD1 diet, ad libitum
- Water (e.g. ad libitum): municipa, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24
- Humidity (%): 66
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

gavage using syringes with plastic catheter

Doses:

2000 mg/kg, 500 mg/kg, 250 mg/kg, 100 mg/kg

No. of animals per sex per dose:

Five males and five females at the initial dose of 2000 mg/kg of bodyweight.
Five males and five females at 500 mg/kg of bodyweight
Five males and five females at 400 mg/kg of bodyweight
Five males and five females at 320 mg/kg of bodyweight
Five males and five females at 250 mg/kg of bodyweight.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy with appearance of organs

Statistics:

method of Weil, 1952, Biometrics 8: 249.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

397 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

370 mg/kg bw

Based on:

test mat.

Effect levels 3

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

432 mg/kg bw

Based on:

test mat.

Mortality:

All rats at dose levels at 400 mg/kg and above died within 3 hours of dosing.

Clinical signs:

other: Salivation, piloerection, pallor of the extremeties, hunched posture, decreased respiratory rate, and lethargy. Additionally, ptosis at 400 mg/kg, body tremors at 250 mg/kg, and prostration at 400 and 500 mg/kg were noted.

Gross pathology:

Autopsy revealed no macroscopic abnormalities among the rats that died.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

The LD50 is between 300 mg/kg and 2000 mg/kg.

Conclusions:

The LD50 of distilled NBTB in female rats was 432 mg/kg, and in males, 370 mg/kg.