Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
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other: Non-GLP, non guideline study, available as unpublished report, limitations in design and/or reporting but otherwise adequate for assessment.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:
24 hour application of undiluted vinyl acetate (4, 8 or 16 mL/kg) to clipped skin maintained under an occlusive dressing. Post exposure observation 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:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Not reported
- Age at study initiation: 3-5 months
- Weight at study initiation: Not reported
- 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

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Not reported
- Type of wrap if used: VINYLITE covering

REMOVAL OF TEST SUBSTANCE
- Excess liquid removed after 24 hour application period

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Maximum dose that could be retained was 20 mL/kg
Duration of exposure:
24 hours
Doses:
4, 8 and 16 mL/kg
No. of animals per sex per dose:
4 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:
8 mL/kg bw
95% CL:
4.9 - 13.1
Remarks on result:
other: 7440 mg/kg
Mortality:
0, 2 and 4 deaths following dermal application of 4, 8 and 16 mL/kg respectively.
Clinical signs:
At 16 mL/kg, convulsions were seen within 15-30 minutes, vocalisation (reported as "crying"), pupils turned inward, all animals died within 25-70 minutes. No clinical signs were reported at the other dose levels.
Body weight:
Weight change over study period -230 to +44 g at 8 mL/kg and -320 to +284 g at 4 mL/kg.
Gross pathology:
Congestion of lungs and liver; spleen and kidney mottled; liver acini prominent.
Other findings:
Skin effects: At 16 mL/kg, skin was brown. At 8 mL/kg, erythema, oedema and necrosis was present.

Applicant's summary and conclusion

Interpretation of results:
sligthly toxic
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
The acute dermal LD50 for vinyl acetate to male rabbits was 8.00 (4.90-13.1) mL/kg, equivalent to 7440 mg/kg.
Executive summary:

The acute dermal toxicity was assessed in groups of 4 male New Zealand White rabbits. Dose volumes of 4, 8 or 16 mL/kg undiluted vinyl acetate were applied to the clipped intact skin under an occlusive dressing for 24 hours. At 16 mL/kg, all rabbits died within 70 minutes and at 8 mL/kg, 2/4 rabbits died within 2 days of exposure. Clinical observations seen at 16 mL/kg prior to death included convulsions, vocalisation (reported as "crying") and pupils turned inwards. At 8 mL/kg, skin observations included erythema, oedema and necrosis following the 24 hour dermal exposure. No other clinical observations were reported. Gross post mortem findings included congestion of lungs and liver, mottling of the spleen and kidney, and prominent liver acini. The acute dermal LD50 for vinyl acetate to male rabbits was 8.00 (4.90-13.1) mL/kg, equivalent to 7440 mg/kg.