Butylamine

Specific investigations: other studies

Administrative data

Endpoint:

specific investigations: other studies

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1993

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: American Society for Testing and Materials (ASTM), Standard Test Method for Estimating Sensory Irritancy of Airborne Chemicals, Annual Book of ASTM Standards Designation E 981-84

Principles of method if other than guideline:

Comparative study including a series of primary, secondary and tertiary amines:
Determination of sensory irritation potency by oronasal exposure, key parameter: RD50
(RD50 = the exposure concentration resulting in a 50-% decrease in the respiratory rate).

GLP compliance:

not specified

Type of method:

in vivo

Endpoint addressed:

respiratory irritation

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:

n-Butylamine [CAS No. 109-73-9], from Fluka, purity >99%

Specific details on test material used for the study:

- Name of test material (as cited in study report): n-butylamine
- Substance type: organic
- Physical state: liquid
- Analytical purity: no data, "high purity"

Test animals

Species:

mouse

Strain:

other: OF-1

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Domaine des Oncins, Saint Germain sur l´Arbresle
- Age at study initiation:
- Weight at study initiation: 20 - 25 g
- Fasting period before study: unfasted
- Housing: 10
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 d
ENVIRONMENTAL CONDITIONS:
controlled, air-conditioned (no details)

Administration / exposure

Route of administration:

inhalation: vapour

Vehicle:

unchanged (no vehicle)

Details on exposure:

nose only exposure

Analytical verification of doses or concentrations:

yes

Details on analytical verification of doses or concentrations:

Adsorption of the test substance to silica gel followed by desorption under simultaneous derivat
isation (m-toluene derivatives). Direct analysis: reverse-phase HPLC.

Duration of treatment / exposure:

15-60 min

Frequency of treatment:

single exposure

Doses / concentrations

Remarks:

Several concentrations measured from 83 - 215 ppm

No. of animals per sex per dose:

5-6

Control animals:

other: internal control = each test animal before exposure

Details on study design:

Before, during and after exposure respiratory rate was determined:
Observation period: 60 min exposure, measurement 1x/15 min, 30 min recovery

Results and discussion

Details on results:

Respiratory irritation, 15 min RD50: 0.26-0.34 mg/L air, 84.0-112.0 ppm (analytical)

Any other information on results incl. tables

The RD50 was found to be 112 ppm = 0.34 mg/L (Gagnaire et al. 1989).

84 ppm = 0.26 mg/L is stated by Gagnaire et al. 1993.

Note: Calculation based on MW = 73 and molar volume of 24 L (20 °C): 1 ml/m3 = 3.04 mg/m3.

Applicant's summary and conclusion

Conclusions:

In mice, n-butylamine is an acute sensory irritant when inhaled: effective exposure levels in mice = ~80 - 110 mL/m3 = ~240 - 340 mg/m3
that produce a 50% suppression of the respiration rate.