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EC number: 203-545-4
CAS number: 108-05-4
Recent GLP Compliant Guideline tests (RCC,
2003a; 2003b) indicate only mild irritation of the skin and eyes of
rabbits. However severe irritation in the respiratory tract of rats has
been reported in repeat-dose studies.
The key study is a recent GLP compliant
evaluation of the skin irritation potential of vinyl acetate (RCC,
2003a). The study was performed according to current guidelines (OECD
404, B.4 92/69 EEC) and is considered the most suitable study for risk
characterisation. Following semi-occlusive application of 0.5 mL of
vinyl acetate (99.9% purity) to intact skin, mean erythema scores at 24,
48 and 72 hours after application were 0.7 / 0.3 / 0, giving an overall
mean of 0.33. This
mild irritation induced by vinyl acetate had disappeared in all animals
after 3 days. Oedema was not observed and there were no corrosive
Some earlier studies (including Industrial
BIO-Test Labs. Inc., 1972 and Mellon Institute, 1969) may have indicated
more pronounced irritation or corrosion of skin after extended exposure
periods, however the guideline study of RCC, 2003a is judged to be the
most appropriate study available.
The key study is a recent GLP compliant
evaluation of the eye irritation potential of vinyl acetate (RCC,
2003b). The study was performed according to current guidelines (OECD
405, B.5 92/69 EEC) and is considered the most suitable study for risk
Undiluted vinyl acetate (0.1 mL, 99.9 %
purity) was placed in the conjuctival sacs of three rabbits. One hour
after the application mild redness and chemosis of conjunctivae were
observed although fully reversible in all animals after 48 and 24 hours,
respectively. There was no indication of any change in corneal opacity
or iris. The mean scores determined after 24, 48 and 72 hours were 1/0/0
for redness and 0/0/0 for chemosis, corneal opacity and iris. The
overall mean score for redness was therefore 0.33 and was fully
reversible 48 hours after application.
Earlier studies for example, Mellon
Institute (1969), support these findings.
Severe irritation in the respiratory tract
of rats and mice has been reported for vinyl acetate. For example,
although no treatment-related clinical signs were reported at 50 ppm
(176 mg/m³) , mice exposed at 1000 ppm (3520 mg/m³) exhibited
respiratory distress throughout the treatment period (Hazleton 1980e).
Similarly in rats, no clinical signs attributable to treatment were
reported from the groups exposed to 50 and 200 ppm (176 and 704 mg/m³).
However at 1000 ppm (3520 mg/m³), an intermittent incidence of
respiratory distress was reported (Hazleton, 1980d). Refer to the acute
and repeat dose toxicity sections for further detail. The conversion of
ppm to mg/m³ is based on Rm of 86.09, 25 °C, 1 atmosphere.
The only human information available is from
exposed workers, who are reported to exhibit local irritant reactions of
the skin, eyes and respiratory tract (Deese & Joyner,1969; EU RAR,
Effects on respiratory irritation:
The most reliable tests (RCC, 2003a and
2003b) indicate mild irritation of the skin and eyes of rabbits that do
not warrant classification. Earlier studies, of limited reliability,
indicated more pronounced irritation or corrosion of skin after extended
However, inhalation tests with rats
demonstrated severe irritation in the respiratory tract. Thus, vinyl
acetate should be labelled with STOT - Single exposure Cat 3, H335 May
cause respiratory irritation according to Regulation (EC) No 1272/2008.
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