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EC number: 203-933-3
CAS number: 112-07-2
Oral route (surrogate substance with mol wt correction: LOAEL=94mg/kgbw/day.Dermal route (surrogate substance with mol wt correction: LOAEL=203mg/kgbw/day.
There is no data available on repeat dose toxicity of butylglycol
acetate by the oral route. Glycol ether acetates are rapidly hydrolysed
in vivo to the parent glycol ethers by plasma esterases and are thus
likely to exhibit the same systemic toxicity profile as the parent
glycol ether. Good oral sub-chronic toxicity data is available for the
parent glycol ether of 2 -butoxyethyl acetate, i.e. 2 -butoxyethanol in
both rats and mice. Repeat dose oral toxicity testing with the latter
has given the following results: body weight reduction, haemolysis,
hepatic effects and local irritation effects. Overall, a LOAEL of 69
and 82 mg /kg bw/d (in males and females respectively) can be
a molar basis, an extrapolation of this LOAEL to an equivalent for 2
-butoxyethyl acetate would be 94 and 111 mg/kg, for males and females
respectively with effects being solely attributed to the direct or
indirect effects of haemolysis.
There is no repeat dose toxicity data available for 2 -butoxyethyl
acetate (BEA) by the dermal route. Since the critical effects are
haematotoxicity, which is associated with the metabolite 2
-butoxyethanol (2BE), the data for the latter, which is much more
extensive and reliable, can be taken into account. The results obtained
in these studies are summarised in the next paragraph.
Two studies are available on rabbits to assess the toxicity of repeated
doses of 2BE administered dermally. In one study, signs of toxicity were
recorded and were limited to transient signs of haemolysis on rabbits.
This study led to a NOAEL of 450 mg/kg bw/d due to haematological
effects seen at 900 mg/kg bw/d. Given that this study was performed for
only 9 days, the NOAEL of the second study on rabbits, which was
performed for 13 weeks, is regarded as more reliable for drivation of a
DNEL. This NOAEL was 150 mg/kg bw/d. The equivalent on a mole basis for
BEA is 203mg/kg/day.
In sub-acute and chronic studies performed with 2 -butoxyethyl acetate
(BEA), signs of haematotoxicity and associated kidney lesions were seen
in rats and rabbit. Rabbits seemed particularly sensitive to these
adverse effects. However, the studies available only used a single
exposure concentration so it is not possible to derive a meaningful
NOAEC from them. Since the critical effects are haematotoxicity, which
is associated with the metabolite 2 -butoxyethanol (2BE), the data for
the latter, which is much more extensive and reliable, can be taken into
account. The results obtained in these studies are summarised in the
There are a number of substantial studies are available for 2BE in rats,
and mice. Robust summaries for the key studies identified are included
here. (A number of other less well reported short exposure studies using
dogs, guinea-pigs and non human primates have also been conducted, but
since these do not impact the derivation of the DNEL for 2BE they are
not included in this dossier.) Similar effects are seen in both rats and
mice. These effects are similar to those observed following acute
administration. The main effect is haemolysis, which
is consistently observed and sometimes associated with secondary hepatic
effects (Kupffer cells pigmentation and absolute and relative liver
weight increases). Other effects include decreases of body weight gain,
hyaline degeneration of the olfactive epithelium, effects on the
forestomach and effects on the WBC sub-populations (T lymphocyte). From
these studies on 2BE, a NOAEC of 25 ppm in rats and a LOAEC of 31 ppm in
mice and rats can be established (based on haemolysis, as the only
significant primary effect seen at any exposure concentration examined).
The LOAEC of 31 ppm ( from a six month satellite group in the NTP, 2000
104-week study) is taken into account for the risk characterisation of
both 2BE and BEA with an appropriate assessment factor to acknowledge
that there is a NOAEC of 25ppm available and no other lesion was
identified that could be specifically attributed to treatment to 2BE.
In selecting an appropriate assessment factor it should be borne in mind
that humans fall into the group of species that are resistant to the
haemolytic effects of 2BE whilst rats, mice and rabbits are very
sensitive to this effect and that no toxic effects other than
haemotoxicity could be attributed to treatment in any repeat dose study.
The no effect levels established, bearing in mind the critical effects
at the LOAEL and their relevance to humans, do not meet the criteria for
classification for repeat dose toxicity.
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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