1,3-dioxolane

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: This study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,3-dioxolane

EC Number:

211-463-5

EC Name:

1,3-dioxolane

Cas Number:

646-06-0

Molecular formula:

C3H6O2

IUPAC Name:

1,3-dioxolane

Details on test material:

- Name of test material (as cited in study report): 1,3-dioxolan- Physical state: liquid- Analytical purity: 99.9%

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 7 weeks (M) or 8 weeks (F)
- Weight at study initiation: 190-193 g (M) or 175-184 g (F)
- Fasting period before study: about 16 h prior to dosing and 3-4 hours following dose administration
- Housing: in groups of 5 animals, in Makrolon Type 4 cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hrs dark, 12 hrs light


IN-LIFE DATES: From: 24 August 1987 To: 14 September 1987

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

Limit test at 2000 mg/kg bw (dose volume 10 mL/kg bw).

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations six times on the day of treatment and once daily afterwards. Weighings on day 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: no

Statistics:

none.

Results and discussion

Preliminary study:

A preliminary study was conducted at 500, 1000 and 2000 mg/kg bw, using 1 male and 1 female rat per dose. No mortality occurred. Clinical signs were: reduced spontaneity, hunched position, flanks drawn in, high-legged, uncoordinated and instable gait, irregular breathing, crawling-type forward movement, lethargy and narrowed eyelids. Normal body weight development.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: limit test

Mortality:

No mortality occurred.

Clinical signs:

other: Observed on the day of treatment only in male and female rats: reduced spontaneity, hunched position, flanks drawn in, high-legged, uncoordinated and instable gait, irregular breathing.

Gross pathology:

No macroscopic findings were observed.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Acute oral LD50 >2000 mg/kg bw

Executive summary:

An acute oral toxicity study (limit test) on 1,3-dioxolane was performed in young adult Wistar rats (5 males and 5 females) according to OECD 401 at a dose of 2000 mg/kg bw. The test material was dissolved in water (dose volume 10 mL/kg bw). No mortality occurred. Treatment related signs of intoxication were observed on the day of treatment only in male and female rats: reduced spontaneity, hunched position, flanks drawn in, high-legged, uncoordinated and instable gait, irregular breathing. There was no treatment apparent effect on body weight gain. No macroscopic findings were observed. The acute oral LD50 is >2000 mg/kg bw.