3-isopropoxypropylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP, OECD 401Guideline, E.C. 92/69/EEC B1

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

: relative humidity sometimes out of the specified range

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-isopropoxypropylamine

EC Number:

220-816-2

EC Name:

3-isopropoxypropylamine

Cas Number:

2906-12-9

Molecular formula:

C6H15NO

IUPAC Name:

3-(propan-2-yloxy)propan-1-amine

Details on test material:

- Name of test material (as cited in study report): 3-isopropoxypropylamine
- Physical state: liquid
- Analytical purity: 99.78%
- Purity test date: 1997-08-07
- Lot/batch No.: 9708P0073
- Expiration date of the lot/batch: December 1998
- Stability under test conditions: no data
- Storage condition of test material: in dark and at room temperature
- Other: origin: Usine de Maurienne La Chambre

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: ICO: OFA-SD (IOPS Caw)
- Age at study initiation: approx 6 weeks old
- Weight at study initiation: 187+/-4g (males) and 140+/-6g (females)
- Fasting period before study: approx 18hours before dosing, but free access to water
- Housing: ( rats of the same sex per cage (48x27x20cm in polycarbonate)
- Diet (e.g. ad libitum): ad libitum A 04 C pelleted diet (U.A.R. 91360 Villemoisson sur Orge, France), except duting fasting
- Water (e.g. ad libitum): ad libitum drinking water filtered by FG Millipore membrane (0.22µ)
- Acclimation period: at least 5days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/-2°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approx 12cycles
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 500, 1000 and 2000mg/kg
- Amount of vehicle (if gavage): gavage 10mL/kg
- Justification for choice of vehicle:solubility
- Lot/batch no. (if required): no data
- Purity: no data

Doses:

50, 1000, 2000mg/kg

No. of animals per sex per dose:

2000mg/kg: 5males and 5females
1000mg/kg: 5females
500mg/kg: 5females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals observed frequently after administration and then once daily, and weighted on days 1, 8 and 15
- Necropsy of survivors performed: yes

Statistics:

LD50 value calculated according to Probit analysis (Weber 1972 and Bliss 1938).
The confidence interval limits are calculated according to Fieller's method (1944)

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

909 mg/kg bw

Based on:

test mat.

95% CL:

417 - 1 755

Mortality:

2000mg/kg: all animals died on day 1
1000mg/kg: 2/5females died on day1
500mg/kg: 1/5female died on day 2

Clinical signs:

other: 2000mg/kg: hypoacticity, sedation, piloerection, tremors, lateral recumbency, dyspnea 1000mg/kg: sedation, tonico-clonical convulsions, lateral recumbency prior to death. hypoactivity, dyspnea, piloerection for survivors 500mg/kg: sedation, piloerection

Gross pathology:

The stomach of the animals given 2000mg/kg had a reddish appearance
No apprent abnormalities were observed in the animals given 1000 or 500mg/kg

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

The oral LD50 of 3-isopropoxypropylamne is 909mg/kg (417-1755mg/kg) in female rats with 95% confidence interval limits.

Executive summary:

The Acute oral toxicity of 3-isopropoxypropylamine was evaluated in male and female rats according to OECD N°401 guideline (Acute Toxic Standard Method) (Manciaux, 1988). All animals died on day 1 after administration of 2000 mg/kg. They showed hypoactivity, sedation, piloerection, tremors, lateral recumbency and dyspnoea prior to death. After administration of 1000 mg/kg, 2/5 rats showed sedation, tonico-clonical convulsions and lateral recumbency prior to death on day 1. Theses clinical signs were less severe in surviving animals. At 500mg/kg, 1/5 animal showed sedation, piloerection and lateral recumbency and then died on day 2. The oral LD50 of 3-isopropoxypropylamine was 909mg/kg (417-1755mg/kg) in female rats with 95% confidence interval limits.