Registration Dossier

Administrative data

Endpoint:
dermal absorption
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Non-GLP, non-guideline, animal experimental study, only brief summary available, acceptable with restrictions.

Data source

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

Materials and methods

Principles of method if other than guideline:
The toxicity of vinyl acetate was assessed following dermal exposure of rabbits.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Radiolabelling:
no

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
Single application, no data regarding duration
Doses:
4, 8, 16 mL/kg bodyweight
No. of animals per group:
4
Details on study design:
Vinyl acetate (undiluted) was applied dermally under Vinylite covering. Animals were placed in a hood with their heads protruding into the room to prevent the inhalation of vapour.

Results and discussion

Signs and symptoms of toxicity:
yes
Remarks:
see table below
Dermal irritation:
yes
Remarks:
see table below
Absorption in different matrices:
Systemic toxicity and gross pathology following occluded dermal exposure demonstrates absorption.

Any other information on results incl. tables

Dose

mL/kg

Dead/dosed

Days to death

Weight change

Skin condition

Signs/Symptoms

16.0

4/4

0,0,0,0

-

Brownish

Convulsions within 15-30 minutes. Crying. Pupils turned upwards. Dead within 25-70 minutes.

8.0

2/4

1,2

-230, +44

Erythema, oedema, necrosis

 

4.0

0/4

-

-320, +24,

+132, +284

 

 

Gross pathology – congestion of the lungs and liver; spleen and kidney mottled; liver acini prominent.

LD50 - 8.00 mL undiluted vinyl acetate/kg.

Applicant's summary and conclusion