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EC number: 204-317-7
CAS number: 119-36-8
study is available for Methyl Salicylate for this endpoint. This study
(LICATA-MESSANA L., 2000) was performed to assess the acute toxicity of
Methyl salicylate to freshwater fish (Danio rerio) under static
conditions. This study was conducted in accordance with the method C.1
of the European Directive 92/69/EC and the OECD guideline 203. A group
of ten fish was exposed to different concentrations of Methyl
salicylate: nominally 1, 10 and 100 mg/L. Observations were made on the
number of dead fish and the incidence of sub-lethal effects after 24,
48, 72 and 96 hours exposure. The 96h-LC50 for freshwater fish (Danio
rerio) was found to be higher than 100 mg/L. Based on these
results, Methyl salicylate is considered as not dangerous to the
aquatic organisms tested in accordance with the Directive 67/548/EC.
the test item concentration levels were not checked although oily
insoluble droplets were observed in the stock solution. Additionally,
although not performed in the same test conditions, the stability study
in the algal toxicity test showed that the concentrations of Methyl
Salicylate decreased significantly within 72 hours.
on these observations, the results of the acute fish toxicity test for
Methyl Salicylate should be used with caution. Therefore, a weight of
evidence approach with results obtained on analog substances is
applied for the assessment of the toxicity to fish of methyl salicylate. Ethyl
salicylate (CAS RN 118 -61 -6) and salicylic acid (CAS RN 69 -72
-7) are used as analog substances.
reliable key study is available for Ethyl salicylate for this
endpoint. In this acute toxicity study (Geiger et al. 1985), fishes from
the speciesPimephales promelaswere
exposedunder flow-through conditionsto
ethyl salicylate (CAS 1118 -61 -6).
average measured concentrations tested were 0 (control), 2.73, 4.82,
7.70, 14.9 and 26.2 mg/L. Twenty five fish were tested in duplicate at
each control and tested concentrations. The resulting LC50
(96h) was 19.8 mg/L,
based on measured concentrations.
ethyl salicylate is harmful to Pimephales promelas in the
study was not performed according to GLP but authors followed a method
similar to OECD 203 and gave sufficient details to check all validity
criteria, which were all fulfilled. Therefore this study is considered
as reliable with acceptable restrictions.
is proposed to use this data for the assessment of the toxicity to fish
of methyl salicylate as a read-across approach. The main assumption
to justify the read-across approach is that both substances have a
similar chemical structure. Both substances are 2-hydroxybenzoate,
one being a methyl ester (i.e. methyl salicylate) and the second one
being an ethyl ester (i.e. ethyl salicylate). Therefore, both substances
have the same functional groups in their chemical structure, and the
addition of an alkyl "CH2" in the ester function for ethyl salicylate
compared to methyl salicylate is not expected to have a significant
impact on the biological and physico-chemical properties of the
assumption is supported by the physico-chemical information which
shows that both substances have very similar physicochemical properties
(including water solubility and vapour pressure). The logKow value
of ethyl salicylate is slightly higher than the one of methyl salicylate
(i.e. 3.09 and 2.55 respectively). It can therefore be expected that
ethyl salicylate has higher effect on the biological cells than methyl
salicylate, and therefore applying the read-across approach would be a
worst case and protective strategy. Even if not completely comparable
due to different test conditions, the toxicity data to Daphnia magna of
both substances show similar conclusion (i.e. 48hEC50 = 28 mg/L for
Ethyl Salicylate and 24hEC50 = 50 mg/L for Methyl Salicylate).
the fact that methyl salicylate is expected to be less toxic than ethyl
salicylate, data on salicylic acid is used to show that the
2–hydroxybenzoic acid is less toxic than the methyl ester, and therefore
that the lower the 2-hydroxybenzoic form is substituted, the lower is
the toxicity. The read-across approach is supported by the
physico-chemical information which shows that both substances have very
similar physicochemical properties (including logKow). But it should be
noted that salicylic acid is more soluble in water than methyl
salicylate (i.e. 1.5 - 2.6 g/L at 20°C - 25°C and 625 mg/L at 30°C
respectively) and less volatile (i.e. 0.0208 Pa at 25°C and 13 Pa at
20°C respectively), but these differences are not expected to impact the
results of the aquatic toxicity test at the concentrations tested.
aquatic toxicity of salicylic acid is assessed based on its sodium
salt to avoid pH effect. In the acute toxicity key study for this
substance (Geiger et al. 1985), fishes from the species Pimephales
exposedunder flow-through conditions
tosalicylic acid sodium salt (CAS
n° 54 -21 -7) at average measured concentrations of 0 (in duplicate),
<50 (in duplicate), 497, 536, 837, 867, 1238, 1272, 2211, 2217, 3442 and
LC50 (96h) was 1370 mg/L (CI:
1270 - 1470 mg/L), based on measured concentrations.
salicylic acid sodium salt is not dangerous to Pimephales promelas in
the conditions tested.
conclusion, the result obtained with ethyl salicylate is used in a worst
case read-across approach to assess the fish toxicity of methyl
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