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EC number: 204-317-7
CAS number: 119-36-8
is available for Methyl Salicylate for this endpoint. This study (DION
M., 1983) is a screening AFNOR Test on daphnids with a test duration of
24h. Toxicity has been observed and result is reported as nominal
concentration as no analytical monitoring as been performed during the
test. Based on the uncertainties of the stability of the test item
during the test and the duration of exposure of 24hours instead of
48hours as required by OECD Testing Guideline, this study is considered
as not reliable.
similarly to the assessment of acute toxicity to fish, a weight of
evidence approach with results obtained on analog substances is
applied for the assessment of the toxicity to aquatic invertebrates 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 (NOACK M., 2001), the acute
immobilization (EC50) of the test item Ethyl salicylate to daphnia
(STRAUS) was determined according to the method C.2 of the European
Directive 92/69/EC and the OECD Guideline 202. The study was conducted
under static conditions over a duration of 48 hours. 20 test organisms
were exposed to each test concentration and control. The test item
dilutions were clearly dissolved after filtration of the saturated
solution in all tested concentration levels throughout exposure. The
real test concentrations were calculated based on DOC-analysis: 9.2, 19,
40, 84 and 165 mg/L. The 48h-EC50 values were calculated by probit
analysis in the tested concentration range. Exposure of daphnids to
Ethyl salicylate resulted in a 48h-EC50 value of 28 mg/L (95% confidence
interval = 27 to 29 mg/L). Based on the results of this study, Ethyl
salicylate is considered asharmful to theaquatic organisms tested
in accordance with the Directive 67/548/EC.
proposed to use this data for the assessment of the toxicity to aquatic
invertebrates 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
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 fish of both
substances show that Ethyl Salicylate is more toxic than Methyl
Salicylate (i.e. 96hLC50 = 19.7 mg/L for Ethyl Salicylate and 96hLC50 >
100 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-hydroxubenzoic 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 and 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.
A 48 hours
acute toxicity study of salicylic acid toDaphnia
magnais available. This study was conducted under static conditions
with nominal concentrations from 276 to 2210 mg/L (pH adjusted to 7.45
+/- 0.05). The 48 hours EC50was determined to be 870
mg/L. Based on the results of this study, 2-hydroxybenzoic acid was not
classified as harmful toDaphnia magnain accordance with the EC
conclusion, the result obtained with ethyl salicylate is used in a worst
case read-across approach to assess the toxicity to aquatic
invertebrates of methyl salicylate.
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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