N-(tert-butyl)benzylamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Guideline study under the current standards of quality assurance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

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.

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: 7-10 weeks
- Weight at study initiation: 200-229 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): 20-23
- Humidity (%): 64
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

One day prior to treatment hair was removed from the dorso-lumbar region of each rat with electrical clippers equal to 10% of the total body surface.
The test substance was applied by spreading it evenly over the prepared skin.
The treated area was wrapped in gauze with impermeable dressing around the trunk.

Duration of exposure:

24 hours

Doses:

All rats received one single dose of 2.0g/kg of bodyweight

No. of animals per sex per dose:

5 females
5 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: day 0 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, pathology, other:

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

1 male rat died within 24 hours of dosing.

Clinical signs:

other: Abnormal gait was observed in all males and two females. Decreased respiratory rate was observed in two males and two females. Other observations: lethargy, pallor of extremities, lacrymation. Recovery by Day 4.

Gross pathology:

Areas of necrosis and slight to well-defined oedema were apparent on Day 2 at all sites of application of the test substance. Scab formation occurred and scabs detached and show apparently normal skin.

Other findings:

Bruising of subcutaneous tissues at site of application.

Any other information on results incl. tables

The acute lethal dose of NBTB was found to be greater than 2000 mg/kg or 2.0 g/kg body weight. Therefore, it is not toxic via the dermal route.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

NBTB was not found to be toxic via the dermal route at doses higher than 2000 mg/kg bw.