Propane-1,3-diol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

ACC PDO panel assigned reliability of 2. PDO from chemical process.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

Remarks:

Acclimatization, humidity, lighting. no controls

GLP compliance:

not specified

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Propane-1,3-diol

EC Number:

207-997-3

EC Name:

Propane-1,3-diol

Cas Number:

504-63-2

Molecular formula:

C3H8O2

IUPAC Name:

propane-1,3-diol

Details on test material:

- Name of test material (as cited in study report): Propane-1,3-diol
- Physical state: Colorless liquid
- Purity: Not reported

Test animals

Species:

rat

Strain:

other: albino (Wistar-derived)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Institute's colony.
- Age at study initiation: Adult
- Weight at study initiation: Males 206 - 292 grams, Females 102 - 139 grams.
- Fasting period before study: Overnight.
- Housing: Housed in groups of five in screen-bottomed, stainless steel cages in a well-ventilated room.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 24°C
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

Single doses of 9.0, 10.8, 13.0, 15.6, or 18.7 ml per kg body weight

No. of animals per sex per dose:

5 males and 5 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Frequency of observations not reported. Body weights not recorded.
- Necropsy of survivors performed: yes

Statistics:

The LD50 was calculated according to the method of Weil (Biometrics (1952) 8:249-263).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 14.9 mL/kg bw

95% CL:

13.7 - 16.3

Mortality:

Most of the deaths occurred between 8 and 23 hours after treatment. One female died on the 4th and one male on the 7th post-treatment day.

Clinical signs:

other: Within a few hours after dosing, the rats showed sluggishness, sedation and ataxia. Unconsciousness was frequently observed and preceded death. After 7 days the survivors recovered gradually and looked quite healthy again at the end of the observation pe

Gross pathology:

Macroscopic examination of the survivors did not reveal any treatment-related gross alterations.

Any other information on results incl. tables

Dose (mL/kg)	Mortality
	Males	Females	%
9.0	0/5	0/5	0
10.8	0/5	1/5	10
13.0	2/5	0/5	20
15.6	3/5	2/5	50
18.7	5/5	5/5	100

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (rat): 14.9 mL/kg

Executive summary:

The acute oral toxicity of 1,3-propanediol was tested in five rats/gender at dose levels of 9.0, 10.8, 13.0, 15.6, or 18.7 mL/kg. The animals were observed for 14 days post-exposure. The LD50 was calculated to be 14.9 mL/kg.