Propionaldehyde

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:

guideline study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Reference 2

Reference Type:

secondary source

Title:

document ID 86-9300000070

Author:

TSCATS

Year:

1992

Bibliographic source:

Microfiche OTS0543436

Report date:

1992

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

only 3 male rats used

GLP compliance:

yes

Remarks:

Bushy Run Research Center

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Propionaldehyde

EC Number:

204-623-0

EC Name:

Propionaldehyde

Cas Number:

123-38-6

Molecular formula:

C3H6O

IUPAC Name:

propanal

Specific details on test material used for the study:

- Name of test material (as cited in study report): propionaldehyde
- Physical state: liquid
- Analytical purity: approx. 99.77%
- Impurities (identity and concentrations): n-propanol: 0.01%, 2-methyl butyraldehyde: 0.02%, valeraldehyde: 0.06%, propionic acid: 0.07%, propionaldehyde dimers: 0.03%, propionaldehyde trimers: 0.01%, all other: approx. 0.03%
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Sprague Dawley, Inc. (Indianapolis, IN, USA)
- Age at study initiation: female: 6-11 weeks, male: 6-8 weeks
- Weight at study initiation: female: 220-240 g, male: 195-215 g
- Fasting period before study: 18 hours
- Housing: up to 5 per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.3 - 25
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: varied by changing the concentration of the test substance in the dosing dilutions and maintaining a constant dose volume.

MAXIMUM DOSE VOLUME APPLIED: 1ml of dose / 100g of rat body weight

DOSAGE PREPARATION: each dosing mixture was prepared just prior to administration by diluting the appropriate amount of propionaldehyde with distilled water. All dilutions were mixed for approximately 2 to 3 minutes on a magnetic stirrer.

Doses:

2000, 1410, 1000 mg/kg b.w.

No. of animals per sex per dose:

3 male with 2000 mg/kg,
15 female: 5 per dose
(3 male for preliminary tests)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on the first day of the test and twice a day thereafter (except on weekends or holidays when they were examined for death alone); weights were recorded on the day of dosing and at 7 and 14 days after dosing and at death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

1 690 mg/kg bw

Based on:

test mat.

95% CL:

> 1 440 - < 1 990

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 2 of 3 dead

Mortality:

2/3 male rats at 2000mg/kg b.w. by day 2 after application
5/5 female rats at 2000mg/kg b.w. by day 1 after application
0/5 female rats at 1410 mg/kg b.w.
0/5 female rats at 1000 mg/kg b.w.

Clinical signs:

other: male rats: Marked unsteady gait at 2 min, prostration, marked labored breathing at 3 min; marked sluggishness, lacrimation at 30 min. Partial recovery at 30 min but followed by death at day 1 or 2, if not followed by death recovery at day 2. In 2 of 3 rat

Gross pathology:

male rats: #1: Lunges mottled dark red, liver mottled dark maroon, stomach gray (glandular portion), intestines red (hamorraged), moderate amount of blood in urine. #2: Lungs with multiple, red pinpoint foci. #3: Lungs mottled red; stomach (glandular portion) dark red and purple hemorrhaged), intestine dark brown (possibly necrotic), kidneys mottled tan, moderate amount of blood in urine.
female rats: 2000mg/kg b.w.: Lungs light red to red (5/5), small amount of foam present in trachea (3/5), glandular portion of stomach red and purple (hemorrhaged; 3/5), upper portion of intestines black (necrotic;4/5), liver dark marron (1/5).
female rats: 1410mg/kg b.w.: Glandular portion of stomach light tan with a thickened texture (possibly ulcerated; 1/5), non-glandular portion of stomach enlarged (1/5).
female rats: 1000mg/kg b.w.: Lungs with red foci (1/5), lungs mottled red and pink (2/5), liver anomaly (1/5), pinworms in colon (1/5)

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the experiment conditions chosen, the peroral LD50 for propionaldehyd, expressed in terms of test substance as received, was 1690 mg/kg b.w. for female rats. There was no marked difference between genders.