Reaction mass of toluene and 2-vinyl-1,3-dioxolane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24/07/2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study performed according to international guidelines but not under GLP.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-vinyl-1,3-dioxolane

EC Number:

223-626-8

EC Name:

2-vinyl-1,3-dioxolane

Cas Number:

3984-22-3

Molecular formula:

C5H8O2

IUPAC Name:

2-vinyl-1,3-dioxolane

Constituent 2

Reference substance name:

Toluene

EC Number:

203-625-9

EC Name:

Toluene

Cas Number:

108-88-3

Molecular formula:

C7H8

IUPAC Name:

toluene

Test material form:

liquid

Details on test material:

Batch No.: LF-238-042-F3
Name of test material (as cited in study report): 2-VINYL-1,3-DIOXOLANE
Physical state: colourless liquid
Storage conditions: ambient temperature, protected from light

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
Source: Elevage IFFA CREDO (69210 L'Arbresle, France)
Age: between 5 and 7 weeks
Number and sex: 5 males and 5 female
Acclimation period: during 5 days before the beginning of the test.
Housing: 5 animals per cage
Diet: Pelleted complete rat diet "A04-10" (UAR, 91360 Epinay sur Orge, France)
Water: water acidified at pH = 2.5

ENVIRONMENTAL CONDITIONS
Temperature: 22 ± 2 °C
Humidity: 50 ± 20 %
Air changes: 10/h
Photoperiod: 12 h dark / 12 h light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME ADMINISTERED: 2 mL/kg bw (corresponding to 2000 mg/kg bw)

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 females and 5 males at 2000 mg/kg

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing
Clinical signs and mortality: Animals were observed for any behavioural or toxic effects at 30 minutes, 1, 2, 3, 4, 5 and 6h after administration of the item and thereafter once a day until Day 14.
Bodyweight was recorded on Day-1, at day 1 after administration, and at day 4, 8 and 15 (i.e 3, 7, 14 days after administration of the test item)
- Necropsy of survivors performed: Yes; On Day 15, animals were anaesthetised with sodium pentobarbital 6% at a concentration of 1.16 mL/kg before a macroscopic examination.

Statistics:

None

Results and discussion

Preliminary study:

Not Applicable

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

< 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: all animals were dead between 30 and 60 minutes after gavage administration

Mortality:

The death of all animals was observed between 30 and 60 minutes after gavage administration.
The autopsy carried out on animals showed damages on stomach and duodenum on all animals.

Clinical signs:

Not applicable

Body weight:

Not applicable

Gross pathology:

Not applicable

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

The oral LD50 for REACTION MASS OF TOLUENE AND 2-VINYL-1,3-DIOXOLANE is lower than 2000 mg/kg bw. An additionnal test at 200 mg/kg is necessary to determine the LD50 of the test substance and its classification.

Executive summary:

In an acute oral toxicity study (limit test) performed according to OECD Guideline 401, 10 Sprague Dawley female and male rats (5 males and 5 females) were given a single oral (gavage) dose of REACTION MASS OF TOLUENE AND 2 -VINYL-1,3 -DIOXOLANE at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.

The death of all animals was observed between 30 and 60 minutes after gavage administration. The autopsy carried out on animals showed damages on stomach and duodenum on all animals.

Therefore, the oral LD50 for REACTION MASS OF TOLUENE AND 2-VINYL-1,3-DIOXOLANE is lower than 2000 mg/kg bw. An additionnal test at 200 mg/kg is necessary to determine the LD50 of the test substance and its classification.