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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:
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

Constituent 1
Chemical structure
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 levelsopen allclose all
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
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
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.