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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Principles of method if other than guideline:

BASF-Test.

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Butylamine

EC Number:

203-699-2

EC Name:

Butylamine

Cas Number:

109-73-9

Molecular formula:

C4H11N

IUPAC Name:

butan-1-amine

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): Monobutylamin
- Physical state: clear liquid
- Analytical purity: 99.5 %

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: WIGA, Sulzfeld and MUS RATTUS, Brunnthal, Germany
- Weight at study initiation: 185 ± 15 g.
- Diet: Herilan MRH ( EGGERSMANN KG, Rinteln/Weser, Germany), ad libitum
- Water: tap water ad libitum

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: continuous infusion pump leading to a vaporisation unit, heatad to 70 °C, vapour mixed with fresh air to achieve the tst atmosphere
- Exposure chamber volume: 200 L
- Method of holding animals in test chamber: in cages within the inhalation chamber


TEST ATMOSPHERE
- Brief description of analytical method used: gas chromatography (HP 5840 A)
- Samples taken from breathing zone: no

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

nominal: 1.48, 7.38, 8.9, 11.1 mg/L
analytical: 0.98, 3.11, 4.94, 7.29 mg/L

No. of animals per sex per dose:

10

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of exposure and daily thereafter
- Frequency of weighing: days 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

4.2 mg/L air (analytical)

95% CL:

3.6 - 4.7

Exp. duration:

4 h

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LC50

Effect level:

4.7 mg/L air (analytical)

95% CL:

3.7 - 5.7

Exp. duration:

4 h

Effect levels 3

Key result

Sex:

female

Dose descriptor:

LC50

Effect level:

3.7 mg/L air (analytical)

Exp. duration:

4 h

Mortality:

See details in remarks on results.

Clinical signs:

other: 3.11, 4.94 and 7.29 mg/l air: watery eye and nose discharge, snout wiping, eyelid closure, dyspnoea, apathy, corneal opacity, squatting posture, trembling gait, ruffled fur. 0.92 mg/l air: watery eye and nose discharge, intermittend and irregular respir

Body weight:

Reduced weight/weight gain. See details in remarks on results.

Gross pathology:

Animals that died:
Heart: acute dilatation, acute congestion;
Lung: slight to moderate distension;
Liver: pivotally lobular pattern.

Sacrificed animals: no abnormalities.

Any other information on results incl. tables

Mortality:

Analytical concentration (mg/l)

male

female

7.29

9/10

10/10

4.94

6/10

9/10

3.11

1/10

2/10

0.92

0/10

0/10

Weight:

Dose (mg/l)	Gender	0 h	7 days	14 days
7.29	male	175	130	156
7.29	female	172	-	-
4.94	male	195	143	173
4.94	female	173	142	209
3.11	male	182	156	181
3.11	female	183	150	158
0.92	male	186	197	239
0.92	female	180	199	211
control	male	186	228	265
control	female	176	189	211

The test substance caused systemic toxicity (including mortality) and local irritation in a dose-dependent manner.

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

Under the conditions of the test an LC50 of 4200 mg/m3 was observed in rats.

Executive summary:

Rats (10 male and females per group were exposed to vapour concentrations of 0.92, 3.11, 4.94 or 7.29 mg/L. Mortality was observed at concentrations of >/= 3.11 mg/L. The LC50 was 4.2 mg/L (4200 mg/m3) for males/females and 4.7 mg/L for males and 3.7 mg/L for females. Symptoms of treatment were severe aqueous-reddish discharge from eyes and nose, apathy, dyspnea,hunched posture,staggering gait, milky turbid corneas. Organ changes consisted in cardiac dilatation with acute hyperemic congestion, slight to moderate acute congestion of the lung.