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EC number: 266-380-7
CAS number: 66492-51-1
SkinRabbit, 4h, semiocclusive: irritating (CrayValley 1999, according to OECD 404 and GLP)Rabbit, 4h, semiocclusive: mildly irritating (BASF SE 1998, according to OECD 404 and GLP)EyeRabbit: not irritating (Cray Valley 1993, according to EU Method B5 and GLP)
Bald skin was observed on day 14 (animal #2, 3)
Scaliness was observed after 7 days in all animals and on day 14 in
animal no. 1
There are valid in-vivo data available for the assessment of the skin
and eye irritation potential of (5-ethyl-1,3-dioxan-5-yl)methyl acrylate.
In an acute dermal irritation or corrosion study according to OECD 404
and GLP, 0.5 ml of the test substance were topically applied to the
intact skin of three New Zealand White rabbits for 4 hours under
semiocclusive dressing (Cray Valley, 1999). Moderate to severe or severe
erythema and moderate or severe oedema were observed in the treated
skin-areas of the three rabbits. The skin irritation had resolved in all
animals at termination (after 14 days). Scaliness was observed among the
animals after 7 days and/or 14 days. Bald skin was noted in two animals
at termination (after 14 days).
In a second in vivo study according to OECD 404 and GLP, 0.5ml of the
test substance were applied to the intact skin of 6 New Zealand White
rabbits for 4h under semi-occlusive conditions (BASF, 1998). Moderate to
severe erythema with moderate oedema and desquamation (characterised by
dryness and sloughing) was noted in one rabbit. Reactions were
persistent in this animal until study termination on day 14.
Well-defined erythema with or without very slight oedema was seen in
three animals, that were fully reversible either after 7 or 8 days.
Transient very slight erythema only was observed in one further animal
up to 24h after removal of the dressing. No dermal reactions were seen
in the sixth animal.
3 New Zealand White rabbits were subjected to a single ocular
application of 0.1ml of the test substance on day 0 in a GLP study
according to EU Method B.5 (Cray Valley 1993) . Slight irritation was
observed 1h after installation, which was reversible within the first
day. Thus, the average scores (24 to 72h) for all rabbit were calculated
to be 0.0 for corneal opacity, 0.0 for iris, 0.0 for conjunctivae
redness, and 0.0 for chemosis.
In two studies, skin irritation was observed. Though severity of these
reactions in the second study just miss the classification criteria
according to CLP/EU-GHS, reactions in one rabbit persisted until the end
of the study and more severe skin reactions were observed in the first
study. No corrosion was observed in both studies Thus
(5-ethyl-1,3-dioxan-5-yl)methyl acrylate is classified as R38 according
to 67/548/EEC and as skin irritant Category 2 according CLP/EU-GHS.
Since no eye irritation was observed 24 h to 72 h after instillation,
classification according to 67/548/EEC or CLP/EU-GHS is not justified.
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