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Toxicological information

Acute Toxicity: oral

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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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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.
Body weight:
Normal body weight development. For males, 28-29% bodyweight gain between day 0 and 7 and 45-50% between day 0 and 14. For females, 13-18% bodyweight gain between day 0 and 7 and 19-25% between day 0 and 14.
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.