Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 January 2002-21 February 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Vinylene Carbonate
- Physical state: clear colourless liquid
- Analytical purity: 99.9%
- Purity test date: 7 January 2002
- Lot/batch No.: 011220
- Storage condition of test material: approx. 4 ºC in the dark, under nitrogen

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Sprague-Dawley CD(Crl:CD(SD)IGS BR)
- Source: Charles River (UK) Ltd., Margate, Kent, UK
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 192-257g; 2 females were below the weight range specified in theprotocol, but this was not considered to affect the purpose or integrity of the study.
- Fasting period before study: overnight fasting immediately before dosing and for 4 hours after dosing
- Housing: in groups of 3 by sex in solid-floor polypropylene cages furnished with woodflakes
- 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): 15
- Photoperiod (hrs dark / hrs light): 12/12


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
DMSO
Details on oral exposure:
Dose level of 2000 mg/kg: the test material was used as supplied. The specific gravity was determined (1.342) and used to calculate the appropriate dose volume for the required dose level (1.5 ml/kg).

VEHICLE for the dose level of 200 mg/kg: DMSO
- Concentration in vehicle: 20 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg

DOSAGE PREPARATION (if unusual):
The test material was warmed at 25 ºC in a warming bath to produce a liquid before use.

Doses:
2000 mg/kg
200 mg/kg
No. of animals per sex per dose:
dose level 2000 mg/kg: 3 females
dose level 200 mg/kg: 3 females, 3 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations for death and signs of toxicity: 0.5, 1, 2 and 4 hrs after dosing and subsequently once daily for up to 14 days. Weighing prior to dosing and 7 and 14 days after treatment or at death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ macroscopic observations
Statistics:
No data.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
300 - 500 mg/kg bw
Mortality:
All females treated at a dose level of 2000 mg/kg were found dead within 30 minutes of dosing. There were no deaths noted in animals treated at a dose level of 200 mg/kg.
Clinical signs:
No signs of systemic toxicity were noted during the study.
Body weight:
The surviving animals showed expected gains in bodyweight over the study period.
Gross pathology:
Abnormalities noted at necropsy of animals treated at a dose level of 2000 mg/kg that died during the study were haemorrhagic lungs, dark liver and dark kidneys. No abnormalities were noted at necropsy of animals treated at a dose level of 200 mg/kg that were killed at the end of the study.
Other findings:
None.

Applicant's summary and conclusion

Interpretation of results:
other: Harmful
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD (Crl:CD(SD)IGS BR) strain rat was estimated to be in the range of 300-500 mg/kg bw.
The test material was classified as Harmful and the symbol Xn and risk phrase R22 ""Harmful if swallowed"" are required according to EU labelling regulations Commission Directive 93/21/EEC.
Executive summary:

The study was performed to assess the acute oral toxicity of VC following a single oral administration in the Sprague-Dawley CD (Crl:CD(SD)IGS BR) strain rat according to OECD 423. The test material was administered undiluted for the 2000 mg/kg dose level and as a solution in DMSO for the 200 mg/kg dose level. All females treated at dose level of 2000 mg/kg were found dead within 30 minutes. No deaths were noted at the dose level of 200 mg/kg. The LD50 was estimated within the range of 300-500 mg/kg.