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EC number: 202-284-3
CAS number: 93-89-0
oral:The LD50 values determined on three studies on rabbits and rats are greater than 2000 mg/kg bw.inhalation:Ethyl benzoate was not toxic as concentrated vapour to rats in an 8 hour inhalation study.dermal:Several studies on different animal species revealed a LD50 of >2000 mg/kg bw.
In this publication, a study is described which
was conducted to assess the oral toxicity of ethyl benzoate in several
animals including rabbits. Ethyl benzoate was administered to a total of
12 rabbits by gavage. Four rabbits each were exposed to one of three
concentrations. These concentrations were in the range of the LD50 value
+/- 0.5 g /kg bw determined by a preliminary toxicity study. As a
result, the LD50 value was found to be 2630 mg/kg bw in rabbits.
Methyl bezoate was tested for its dermal
toxicity in 10 New Zealand White rabbits (5 males and 5 females).
Therefore, a single dose of 2000 mg/kg bw was applied to the rabbits'
skin. Loss of test substance was prevented by using a collar. The
animals were weighted (on days 1, 2, 4, 7 and 14) and observed during
the 14 -day observation period. No deaths occurred. The treated skin
sites showed signs of irritaion. A decrease in body weights was observed
in four male and three female rabbits on day 1 and one female showed a
decrease in body weight during days 4 and 7. At necropsy, no treatment
related findings were observed. Therefore, the LD50 after dermal
application was found to be greater than 2000 mg/kg bw.
Three studies are available for this
endpoint and are used for a weight of evidence approach. In the first
publication, a study is described which was conducted to assess the oral
toxicity of ethyl benzoate in several animals including rabbits. Ethyl
benzoate was administered to a total of 12 rabbits by gavage. Three
concentrations were tested, each dose group consisted of 4 rabbits. As a
result, the LD50 value was found to be 2630 mg/kg bw in rabbits.
the second study which is described in the same publication the material
was tested on rats. Ethyl benzoate
was administered to a total of 45 rats by gavage. Five rats per group
were exposed to one of nine concentrations. As a result, the LD50 value
was found to be 2100 mg/kg bw in rats.
the third publication an acute oral toxicity tests of ethyl benzoate and
other substances in rats is described.
Therefore, female Carworth-Wistar rats were used. The test substance was
administered to five rats per dose group. The maximum dose volume did
not exceed 10 mL. Rats were observed for a period of 14 days and deaths
were recorded. As a result, the LD50 value of the test substance to
female rats was determined to be 6480 mg/kg bw.
As studies are available on acute toxicity
by oral and dermal route, studies on the acute toxicity by inhalation do
not need to be provided. But, as a publication is available, the results
are nevertheless summarized. In this publication it is described how
ethyl benzoate, among other substances, was tested for its acute
toxicity after inhalation in rats. Therefore, female Carworth-Wistar
rats were exposed to concentrated vapour of the test substance for 8
hours. As no deaths occured, it was concluded that the LD50 lies over
the saturated vapour concentration of the test substance. Therefore the
study revealed that ethyl benzoate is not toxic via inhalation and thus
supports the waiving.
Several studies on different animal species
are available analyzing the acute dermal toxicity of ethyl benzoate or
read across substances. These studies were used in an weight of evidence
As a read across substance methyl benzoate
was tested for its dermal toxicity in 10 New Zealand White rabbits (5
males and 5 females). Therefore, a single dose of 2000 mg/kg bw was
applied to the rabbits' skin. Loss of test substance was prevented by
using a collar. The animals were weighted (on days 1, 2, 4, 7 and 14)
and observed during the 14 -day observation period. No deaths occurred.
The treated skin sites showed signs of irritation. A decrease in body
weights was observed in four male and three female rabbits on day 1 and
one female showed a decrease in body weight during days 4 and 7. At
necropsy, no treatment related findings were observed. Therefore, the
LD50 after dermal application was found to be greater than 2000 mg/kg bw.
To assess the acute dermal toxicity of ethyl
benzoate, additionally a publication is available which describes a
study conducted on cats. 20 mL of the substance were applied undiluted
to the clipped backs of two cats. Both animals died after an average
time of 20 hours. Before death, the animals exhibited excessive
salivation, twitching of the treated area, generalized tremor, muscular
incoordination, paralysis of the hind limbs, violent convulsions and
respiratory failure. These results indicate that the LD50 dose lies
under the dose applied, which was calculated to be 10000 mg /kg bw (far
above the required limit dose for acute dermal toxicity testing)
assuming a bodyweight of 2 kg.
Ethyl benzoate was also applied to the back
of mice in another study. Four different concentrations were used: 10 %,
20 %, 50 % and 100 %. Acetone was used as a vehicle. 2 -4 mice of the
same sex were used per dose. The test material was applied to 1/3 of the
body surface. During a 7 days observation period, the skin temperature,
survival, body weight , behaviour and food intake were observed. An
autopsy was performed afterwards. As a result, the highest tolerable
dose was found to be 10 %.
Additionally, ethyl benzoate was applied as
an emulsion or solution to the whole body surface of calves at four
different concentrations: 10 %, 20 %, 50 % and 100 %. The test animals
were 5-6 months old. During a 15 days observation period, no deaths
occurred and no other adverse effects were observed.
As another read across substance, isopropyl
benzoate was applied on the skin of 5 rabbits per dose group. After a 14
days observation period the LD50 was determined to be >2000 mg/kg bw.
Additionally, a single dose of butyl benzoate
was applied to the clipped skin of 10 rabbits (8 males and 2 females).
The exposure site was occluded for 24 hours and afterwards wiped to
remove excess material. Diarrhea was observed during the 14 days
observation period. As no deaths occurred, the LD50 was determined to be
>5000 mg/kg bw.
All these studies indicate an LD50 of >2000
mg/kg bw and therefore no acute dermal toxicity of the test substance.
The available data gave no indications for acute
toxic properties of the test substance either via oral or dermal route or
via inhalation. On the basis of these data the substance is not
considered to be classified for acute toxicity under Directive
67/548/EEC (DSD) or under Regulation (EC) No 1272/2008 (CLP).
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