3-aminopropylmethylamine

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

short-term repeated dose toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from NTRL.

Data source

Reference

Reference Type:

secondary source

Title:

Initial submission: Letter from Eastman Kodak Co to USEPA Regarding Basictoxicity of 3-methylaminopropylamine with Attachments and Cover Letter dated 9/4/92.

Author:

NTRL

Year:

1992

Bibliographic source:

OTS0555335, NTRL, dated 9/4/92

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: As mention beow

Principles of method if other than guideline:

To evaluate the toxic potential of 3-methylaminopropylamine in rats by inhalation for 13 days, 6 hour /day.

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-aminopropylmethylamine

EC Number:

228-544-6

EC Name:

3-aminopropylmethylamine

Cas Number:

6291-84-5

Molecular formula:

C4H12N2

IUPAC Name:

(3-aminopropyl)(methyl)amine

Test material form:

liquid

Details on test material:

- Name of test material : (3-aminopropyl)(methyl)amine; 3-Amino-1-methylaminopropane
- Molecular formula : C4H12N2
- Molecular weight : 88.1528 g/mol
- Smiles notation : N(CCCN)C
- InChl : 1S/C4H12N2/c1-6-4-2-3-5/h6H,2-5H2,1H3
- Substance type: Organic
- Physical state: Liquid

Specific details on test material used for the study:

- Name of test material : (3-aminopropyl)(methyl)amine; 3-Amino-1-methylaminopropane
- Molecular formula : C4H12N2
- Molecular weight : 88.1528 g/mol
- Smiles notation : N(CCCN)C
- InChl : 1S/C4H12N2/c1-6-4-2-3-5/h6H,2-5H2,1H3
- Substance type: Organic
- Physical state: Liquid

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

air

Mass median aerodynamic diameter (MMAD):

7.2 µm

Geometric standard deviation (GSD):

1.41

Details on inhalation exposure:

Details on inhalation exposure
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
Animals were exposed in stainless steel and glass inhalation chambers having an effective animal exposure volume of 420 liters. Atmospheres were produced by passing air over the surface of the liquid contained in a three necked flask maintained at 35° C tor 61 mg/m and 50° C for 189.3, mg/m3 . Vapor laden air exiting the flask vas diluted at a T at which point a chemical or physical reaction occurred resulting in the production of an aerosol. Particle size analysis was done by using a Royco Analyzer over the course or exposure resulted
in a stable distribution with an aerodynamic mass median diameter of 7.2µm and geometric standard deviation of 1.41.
TEST ATMOSPHERE
- Brief description of analytical method used: Approximately82% of the particles was less than 10 um in diameter. Chamber concentrations were determined every 0.5 hour by gas chromatography of sample collected in midget impingers.
- Samples taken from breathing zone: yes

Analytical verification of doses or concentrations:

yes

Details on analytical verification of doses or concentrations:

using gas chromatography

Duration of treatment / exposure:

13 days

Frequency of treatment:

Single exposure for 6 hour/day

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

0 mg/m³ air

Doses / concentrations 2

Dose / conc.:

61 mg/m³ air

Doses / concentrations 3

Dose / conc.:

189.3 mg/m³ air

No. of animals per sex per dose:

Total 12 animals
0.0 mg/m3- four rats
61.0 mg/m3 - four rats
189.3mg/m3- four rats

Control animals:

yes, concurrent vehicle

Details on study design:

Details on study design
Dose were selected from preliminary study

Examinations

Observations and examinations performed and frequency:

Observations and examinations performed & frequency
CAGE SIDE OBSERVATIONS: Not specified

DETAILED CLINICAL OBSERVATIONS: Yes

BODY WEIGHT:

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Not specified

- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Not specified


FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Not specified


WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not specified


OPHTHALMOSCOPIC EXAMINATION: Not specified


HAEMATOLOGY: Not specified


CLINICAL CHEMISTRY: Not specified


URINALYSIS: Not specified


NEUROBEHAVIOURAL EXAMINATION: Not specified


OTHER:

Sacrifice and pathology:

Sacrifice and pathology
GROSS PATHOLOGY: Yes, macroscopic examination for nasal passages, trachea and lung were observed.
HISTOPATHOLOGY: Yes, microscopic examination for nasal passages, trachea and lung were observed.

Statistics:

Not specified.

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Description (incidence and severity):

No significant change were observed at dose level of 61.0 and 189.3mg/m3 in treated group compare to control.

Mortality:

not specified

Body weight and weight changes:

no effects observed

Description (incidence and severity):

No significant change were observed at dose level of 61.0 and 189.3mg/m3 in treated group compare to control.

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

not specified

Clinical biochemistry findings:

not specified

Urinalysis findings:

not specified

Behaviour (functional findings):

not specified

Immunological findings:

not specified

Organ weight findings including organ / body weight ratios:

not specified

Gross pathological findings:

no effects observed

Description (incidence and severity):

No significant change were observed at dose level of 61.0 and 189.3mg/m3 in treated group compare to control.

Neuropathological findings:

not specified

Histopathological findings: non-neoplastic:

effects observed, non-treatment-related

Description (incidence and severity):

As though nasal irrttion was observ ed but no significant change were observed at dose level of 61.0 and 189.3mg/m3 in treated group compare to control.

Histopathological findings: neoplastic:

not specified

Details on results:

The substance is a severe irritant.

Effect levels

Dose descriptor:

NOAEL

Effect level:

189.3 mg/m³ air

Based on:

test mat.

Sex:

not specified

Basis for effect level:

clinical signs

gross pathology

histopathology: non-neoplastic

Remarks on result:

other: No significant change were observed at dose level of 61.0 and 189.3mg/m3 in treated group compare to control.

Target system / organ toxicity

Critical effects observed:

not specified

Treatment related:

not specified

Dose response relationship:

not specified

Relevant for humans:

not specified

Applicant's summary and conclusion

Conclusions:

NOAEL was considered to be 189.3mg/m3 for 3-methylaminopropylamine in rats by inhalation for subacute study.

Executive summary:

In a Repeated inhalation study for 3-methylaminopropylamine in rats by inhalation was observed. The animals were exposed to test material at the concentration of 0.0 , 61.0 and 189.3mg/m³for 13 days by single exposure for 6 hour/day. As no statically significant effects were observed on the clinical sign, gross pathology and histopathology of the treated animal’s other then nasal irritation. This nasal irritation is due to irritant nature of the substance .Therefore NOAEL was considered to be 189.3mg/m^{3 for}3-methylaminopropylamine in rats by inhalation.