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Administrative data

Endpoint:
dermal absorption in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study, published in peer-reviewed literature, minor restrictions in design and reporting, but otherwise adequate for assessment.

Data source

Reference
Reference Type:
publication
Title:
Percutaneous absorption of vinyl chloride.
Author:
Hefner, R.E., Watanabe, P.G., Gehring, P.J.
Year:
1975
Bibliographic source:
Toxicol Appl Pharmacol 34:529-532.

Materials and methods

Principles of method if other than guideline:
Whole-body inhalation exposure (except of head) of rhesus monkeys to radio-labelled vinyl chloride
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Chloroethylene
EC Number:
200-831-0
EC Name:
Chloroethylene
Cas Number:
75-01-4
Molecular formula:
C2H3Cl
IUPAC Name:
chloroethene
Radiolabelling:
yes
Remarks:
14C

Test animals

Species:
monkey
Strain:
other: Macaca mulatta
Sex:
male
Details on test animals or test system and environmental conditions:
Male rhesus monkeys (Macaca mulatta) weighing 4-5 kg were used. 

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Duration of exposure:
For 2.0 and 2.5 hours exposure to 7000 and 800 ppm 14C-vinyl chloride, respectively. 
Doses:
7000 and 800 ppm 14C-vinyl chloride
No. of animals per group:
Not specified.
Control animals:
no
Details on study design:
Prior to exposure 30 mg/kg sodium pentobarbital was administered iv.  An endotracheal catheter with an inflatable collar was inserted into the trachea and connected to a Harvard respiratory pump adjusted to deliver a volume of 20 ml of air at a rate of 28-38 cycles/min.  To ensure an adequate seal around the neck, the hair was removed and the membrane was fitted to the neck and secured to the skin with tape.
To trap VC from the expired air, a polyethylene tube filled with 0.5 g of activated charcoal was placed in the exhaust port of the respiratory pump.  A similar tube placed on the intake port of the respirator filtered any vinyl chloride from the artificially inspired air.  The expired air traps were changed at 0.5 or 1 hr intervals while the intake traps were changed every 2 hours.  Vinyl chloride was eluted from the charcoal with carbon disulfide in a dry ice bath and analyzed by gas chromatography. 
At the end of the study, the animals were sacrificed and selected tissues were weighed and  samples obtained for analysis.  In addition urine and bile were collected and analyzed. Chamber concentrations of vinyl chloride were measured by infrared specrophotometry.

Results and discussion

Percutaneous absorptionopen allclose all
Dose:
800 ppm
Parameter:
percentage
Absorption:
> 0 - < 1 %
Remarks on result:
other: 2 h
Remarks:
Dermal absorption was estimated to be 0.031%
Dose:
7000 ppm
Parameter:
percentage
Absorption:
> 0 - < 1 %
Remarks on result:
other: 2.5 h
Remarks:
Dermal absorption was estimated to be 0.023%
Conversion factor human vs. animal skin:
Not specified.

Applicant's summary and conclusion

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