tert-butylamine

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

1. No guideline specified in the report. The appropriate guidelines are not completely followed (e.g. only male rats exposed instead of both sexes). 2. QA statement added to report: "The mean lethal dose reported may be slightly low. Sampling impinger efficiency was less than required by SOP I013 in that impinger frequently exceeded the concentration limit permitted"

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1980

Materials and methods

Principles of method if other than guideline:

see details in remarks on material and methods.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

tert-butylamine

EC Number:

200-888-1

EC Name:

tert-butylamine

Cas Number:

75-64-9

Molecular formula:

C4H11N

IUPAC Name:

2-methylpropan-2-amine

Details on test material:

- Name of test material (as cited in study report): tertiary butylamine
- Analytical purity: 97-100 %
- Lot/batch No.: TL-50638

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

- Age: 50-70 days
- Weight at study initiation: 207-300 g
- Number of animals: 10/exposure level

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

Type of exposure: whole-body exposure
- Rate of air flow to nebulizer 20 l/min, total chamber air flow 50 l/min
- Particle size: not indicated
- Type or preparation of particles: generation of vapours using a Laskin-style sonic nebulizer

Analytical verification of test atmosphere concentrations:

yes

Remarks:

4 samples/h by gas chromatography.

Duration of exposure:

4 h

Concentrations:

1.25, 2.27, 2.97, 3.03, 4.02, 4.10, 4.64, 6.04, 12.49 mg/L

No. of animals per sex per dose:

10 animals per dose, males only

Control animals:

not specified

Details on study design:

EXAMINATIONS:
- For a 13-14-day observation period, mortality/clinical examinations were made several times on day 1 (2/treatment) and daily thereafter
- macroscopy on all animals
- body weight prior to dosing and on day 7 and 14

Statistics:

Finney Probit Procedure

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LC50

Effect level:

3.8 mg/L air

95% CL:

3.5 - 4.2

Exp. duration:

4 h

Mortality:

- Time of death: all death before day 4

Clinical signs:

other: (a) during exposure: - at all exposure concentrations: lacrimation, labored breathing and gasping and depression of activity - above 2.97 mg/L: blood around nasal/oral region, ptosis, gasping - above 6 mg/L: signs of CNS depression (b) during total o

Body weight:

- Marked weight loss during the first week following exposure in animals receiving the higher doses

Gross pathology:

- All exposure concentrations: lung hemorrhage and thymus hemorrhage
- Above 3 mg/L: gaseous distension of the stomach, inflammatory trachea
- Incidental: pale kidney, enlarged spleen, pale liver, inflamed and bloated small intestine, opacity of lenses

Any other information on results incl. tables

MORTALITY
Dose [mg/L]	Mortality
1.25	0/10
2.27	0/10
2.97	3/10
3.03	0/10
4.02	3/10
4.10	6/10
4.64	10/10
6.04	10/10
12.49	10/10

Applicant's summary and conclusion

Conclusions:

LC50 3.8 mg/l, 95% confidence interval 3.5-4.2 mg/L