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Toxicological information

Acute Toxicity: inhalation

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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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
(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 observation period
- above 3 mg/L: wheezing and opaque eyes, abnormal breathing in some rats
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