Propylene carbonate

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 Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

analytical purity and storage condition are not reported

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Propylene carbonate

EC Number:

203-572-1

EC Name:

Propylene carbonate

Cas Number:

108-32-7

Molecular formula:

C4H6O3

IUPAC Name:

4-methyl-1,3-dioxolan-2-one

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): 5601-57-2
- Physical state: clear liquid
- Analytical purity: responsibility of the Sponsor
- Lot/batch No.: J-253
- Stability under test conditions: no apparent change in the physical state of the test article during administration
- Storage condition of test material: no data
- Other: specific gravity=1.203ml/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 Breeding Labs., Wilmington, Mass.
- Age at study initiation: no info
- Weight at study initiation: 180-280g (fasted)
- Fasting period before study: yes, 18h
- Housing:individually or in groups, according to sex, in stainless steel 1/2'' wire mesh cages. Size i n accordance with the "Guide f o r the Care and Use of Laboratory Animals" of the Institute of Laboratory Resources, National Research .Council
- Diet (e.g. ad libitum): Wayne Lab Blox, ad l ibi tum
- Water (e.g. ad libitum): fresh tap water, ad libitum
- Acclimation period: 5 days


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


IN-LIFE DATES: From: 1985-07-29 To: 1985-08-12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5000 mg/kg

No. of animals per sex per dose:

10 (5 males and 5 females)

Control animals:

no

Remarks:

not required according to OECD 401

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: pharmacological and toxicological effects: at 1 and 4 hours and once a day for 14 days; viability: twice a day; body weight: d0 and d14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: unbounded LD50

Mortality:

None of the rats died during the study

Clinical signs:

other: Salivation was observed immediately after dosing

Gross pathology:

No visible lesions were observed at terminal necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based upon the results of the Acute Oral Toxicity Limit Test in Rats, the acute oral LD 50 proved to be greater than 5000 mg/kg.