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EC number: 203-933-3
CAS number: 112-07-2
All available ORAL LD50 values
Rat: 1600, 1880, 2400-3000, 7000 mg/kg
Mouse: 2820 mg/kg
Rabbit: 118-940mg/kg, ~987mg/kg
Reliable INHALATION LC50 values
Rat: LC50(4hr)>2.66mg/l (SVC); LT50(SVC)=8hr, LC50(8hr)>SVC (3.91mg/l),
where SVC=saturated vapour concentration.
All available DERMAL acute toxicity values:
Rabbit LD50: 1580mg/kg (occlusive exposure)
A number of relatively old but mainly reliable studies are available to
assess acute oral toxicity using various animals. Whilst the reporting
of these falls short of current standards and there are some
uncertainties about the purity and the experimental procedure, together
they provide a consistent picture of the toxicity of this substance. The
toxicological effects were mainly haemolysis and associated lesions. The
data suggests that rabbits are the most sensitive species with a LD50
of around 900 mg/kg, but they are known to be very sensitive to the
haemolytic effects of butoxyacetic acid, the main metabolite of the
hydrolysis product 2 -butoxyethanol, and therefore not representative of
the acute toxicity in humans, who are very resistance to haemolysis
induced by the metabolites of the substance . The LD50 in the preferred
species of rat is significantly higher (lowest reliable values 1880mg/kg
and 2820mg/kg respectively.) Data for mice suggests an LD50 of around
3000mg/kg. A single value of >940mg/kg is available for the cat but this
limit value is of little use for classification purposes. This pattern
of results is consistent with data for the surrogate parent glycol ether
2 -butoxyethanol, where the rabbit is again found to be the most
sensitive species from which the predicted LD50 values would be 1300
-3500mg/kg for rats and 1400 -2700mg/kg for mice. The rat and mouse are
also sensitive to haemolysis, but since there is no data in a haemolysis
resistant species such as the guinea pig, the lowest LD50 from the
preferred species (rat) should be use as a conservative indicator of
acute toxicity in humans.
A number of study results are available across multiple species but all
studies are relatively old and those in species other than rats are
deemed unreliable. However, at least two of these are judged reliable
and all of the other studies provide data which is consistent with these
one or two and lead to the conclusion that the LC50 for this substance
cannot be achieved under ambient conditions due to its low vapour
pressure and relatively low toxicity. Studies using vapour
concentrations between 2.66 -3.91mg/l or 81 >100% of the theoretical
saturated vapour concentration) consistently showed, directly or
indirectly, no lethality for exposures of 4 hours. Other adverse effects
were seen, particularly haemoglobinuria in rats, which is consistent
with the known toxic effects of the main metabolite (2 -butoxyethanol)
of this substance.
There are two studies available for 2 -butoxyethyl acetate. Both were
performed with rabbits. The main toxicity symptoms were haemolysis and
associated lesions. One of the studies is regarded as unreliable since
the LD50 is quoted as an internal (absorbed dose), which is not suitable
for comparison to to the classification criteria. The second study
which is rather old demonstrated an LD50 of 1580 mg/kgbw
The preferred species for classification is the rat. Data is available
for other species, rabbit and mouse, but the reasons for not selecting
these species for the key parameter are described in the section above.
The lowest obtained LD50 data from rats indicates classification is
required (just) although some values obtained suggest classification may
not be required.
The LC50 for this substance cannot be reached under ambient conditions
due to its low volatility. This has been demonstrated in multiple
studies across multiple species which when exposed to saturated vapour
concentrations for 4 hours have not produced any lethality in test
animals. A classification for acute toxicity by the inhalation route is
not therefore warranted. It should be noted that the currently listed
harmonised classification does include classification for this route
and, whilst it was agreed as not appropriate in the EU risk assessment
and confirmed at the EU Classification and Labelling Working Group, this
decision was never implemented under directive 67/548 before it was
repealed by regulation 1272/2008.
The LD50 for exposure under occluded conditions to 2 -butoxyethyl
acetate has been shown to be 1580mg/kg. This would indicate that
classification for acute toxicity by the dermal route is required under
the EU GHS implementation (as category 4).
It should be noted that severe haemolytic anaemia was observed in the
rabbit and this effect is likely to be a significant if not key
contributor to death. This is an effect to which humans are notably
resistant, as are guinea pigs, which could therefore be considered a
more representative species. It is likely therefore that the harmful
classifications above are likely to exaggerate the actual hazard to
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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