3-methoxypropylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 January 1990 - 5 March 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-methoxypropylamine

EC Number:

226-241-3

EC Name:

3-methoxypropylamine

Cas Number:

5332-73-0

Molecular formula:

C4H11NO

IUPAC Name:

3-methoxypropan-1-amine

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): 6398-24-1, Project #90-018
- Physical state: clear colorless liquid
- Analytical purity: responsibility of the Sponsor
- Stability under test conditions: no apparent change in the physical state of the test article during administration
- Other: specific gravity= 0.8725 g/ml

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Inc., Wilmington, Massachusetts
- Age at study initiation: young adults
- Mean weight at study initiation:
500 mg/kg dose group: males: 184.2 g, females: 175.0 g
800 mg/kg dose group: males: 266.6 g, females: 203.6 g
1250 mg/kg dose group: males: 260.6 g, females: 209.6 g
2000 mg/kg dose group: males: 254.6 g, females: 199.6 g
- Housing: individually in stainless steel 1/2" wire mesh cages, sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of
the Institute of Laboratory Animal Resources, National Research Council.
- Diet (e.g. ad libitum): Wayne Teklad Lab Blox, ad libitum
- Water (e.g. ad libitum): fresh tap water, ad libitum
- Acclimation period: minimum 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C±3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12h dark/12h light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Not applicable

Doses:

Dose-range finding study: 500, 2500 and 5000 mg/kg
Definitive test: 500, 800, 1250 and 2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Viability was checked daily. Clinical effects were observed for at 1, 4 and 24h after dosing and once daily thereafter. Body weights were recorded at study initiation, days 7 and 14 or when found dead.
- Necropsy of survivors performed: yes

Statistics:

LD50 calculations performed via Litchfield and Wilcoxon on Pharmacological Calculations System, version 4.1.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

688.1 mg/kg bw

95% CL:

546.9 - 865.6

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

998.9 mg/kg bw

95% CL:

734 - 1 359.5

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

598.4 mg/kg bw

95% CL:

348.6 - 1 027.3

Mortality:

2/10 animals died at the 500 mg/kg dose;
6/10 animals died at the 800mg/kg dose;
10/10 animals died at both the 1250 and 2000 mg/kg dose levels.

Clinical signs:

other: Signs observed included decreased activity, piloerection, descreased muscle tone, abnormal gait, abnormal stance, diarrhea, chromodacryorrhea, dyspnea and prostration.

Gross pathology:

Necropsy of the animals dying on study: distended and/or fluid-filled stomachs and intestines, pale livers and pale kidneys.
Terminal necropsy of the remaining animals: distended fluid-filled intestines in one female rat.

Any other information on results incl. tables

Results of dose range finding study:

Signs observed included decreased activity, abnormal stance, abnormal gait, and dyspnea. None of the animals died at the 500 mg/kg dose level. Two of two animals died at both the 2500 and 5000 mg/kg dose levels. Based upon these results, a definitive LD50 study was performed.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The Acute Oral LD50 in male and female rats for the substance was determined to be 688.1 mg/kg (95%CL of 546.9 to 865.6 mg/kg). Based on the results of this study and according to the criteria of the CLP Regulation the substance should be classified as a category 4 acute oral toxicant.