Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, non guideline study, available as unpublished report, limitations in design and/or reporting but otherwise adequate for assessment.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report Date:
1969

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Undiluted vinyl acetate at 3 dose volumes (2, 4 and 8 mL/kg). 5 male rats per group. Observed for 14 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Vinyl acetate
- Physical state: Liquid
- Supplier: Union Carbide Corporation, Chemicals and Plastics Division, South Charleston, W. Va., USA

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Mellon Institute, Carnegie-Mellon University
- Age at study initiation: 3-4 weeks
- Weight at study initiation: 90-120 g
- Fasting period before study: Non fasted
- Housing: Not reported
- Diet: Rockland diet ad libitum
- Water: ad libitum
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS: Not reported

IN-LIFE DATES: Not reported

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2, 4 and 8 mL/kg
No. of animals per sex per dose:
5 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
Statistics:
LD50 calculated by the moving average method

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
3.73 mL/kg bw
95% CL:
2.52 - 5.59
Remarks on result:
other: 3470 mg/kg
Mortality:
0, 3/5 and 5/5 deaths at dose volumes of 2, 4 and 8 mL/kg respectively. All mortalities were on days 0 or 1.
Clinical signs:
At 8 mL/kg, animals were reported to be sluggish. No clinical signs were reported at the other dose volumes.
Body weight:
At 2 mL/kg bodyweight increase during the study was between 73-74 g and at 4 mL/kg was between 10-67 g.
Gross pathology:
Congestion throughout lungs and abdominal viscera, livers mottled.

Applicant's summary and conclusion

Interpretation of results:
sligthly toxic
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
The acute oral LD50 for vinyl acetate to male rats was 3.73 (2.52-5.59) mL/kg, equivalent to 3470 mg/kg.
Executive summary:

Groups of 5, unfasted, male rats were dosed orally (by stomach intubation) with undiluted vinyl acetate at dose volumes of 2, 4 or 8 mL/kg and were then observed for 14 days. At 8 mL/kg, all five rats died within 1 day of dosing and 3/5 rats dosed at 4 mL/kg died, again on day 0 or 1. At 2 mL/kg all rats survived. The only clinical signs were sluggish behaviour seen in high dose animals. Gross post mortem changes included congestion throughout the lungs and abdominal viscera and mottling of the livers. The acute oral LD50 for vinyl acetate to male rats was 3.73 (2.52-5.59) mL/kg, equivalent to 3470 mg/kg.