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EC number: 220-011-6
CAS number: 2602-34-8
Tests with fish invertebrates and algae
Reliable short-term toxicity data are available for freshwater
fish, invertebrates and algae. 96 h, 48 h and 72 h L(E)C50 values
of >100 mg/l (nominal concentrations) for all three trophic levels and
>71, >59 and >53 mg/l (geometric mean measured concentrations) have been
determined for the effects of the hydrolysis product of the registered
substance with Danio rerio (tested as Brachydanio rerio),
Daphnia magna and Desmodesmus subspicatus (tested as Scenedesmus subspicatus)
Data waivers are applicable for long-term toxicity to fish and
aquatic invertebrate endpoints.
The nature of the substance that the organisms were exposed to in
the short-term tests and the results of analysis of the test media are
given further consideration below and in the subsections relating to
each of the endpoints.
The hydrolysis half-life of the registered substance is 12 – 36
hours at pH 7 and 25°C. However the pH of the test medium was 8 and at
this pH the hydrolysis rate is expected to be 5-10 times faster. In
addition, the use of static and semi-static exposure regimes do not
maximise the exposure to the parent substance. As a consequence it is
therefore likely that the organisms were exposed to a mixture of the
parent substance and the hydrolysis product of the registered substance.
Inspite of this the studies are still considered to be representative of
the effects of the substance because:
mortalities or effects were recorded at the start of the study when
exposure to the parent substance will have been at its highest;
are considered to be the most susceptible taxonomic group to the effects
of epoxides and data are available with a supporting study indicating no
effects at the highest concentration tested;
retention time in WWTP is sufficiently long and the conditions in the
WWTP are such that organisms in the environment would be exposed
predominantly to hydrolysis product (further considerations are
pH values in freshwater environments are variable the pH in the marine
environment is approximately 8 (ECHA 2010c, R.16) and therefore closer
to the pH of the media in the reported tests.
The results of the short-term tests are presented in terms of both
geometric mean-measured and nominal concentrations.The analysis of
the test media in all three studies has been further reviewed. In the
opinion of the reviewer it is likely that because of the poor thawing
protocol, the extraction method and the pH of the test media that the
results relate to hydrolysis product. The presence of only one peak in
the chromatogram also indicates that this is likely to be the case. It
is not possible to determine which intermediate hydrolysis product the
analysis relates to.
Inspite of the above it is still considered appropriate to base
the assessment of the hazards and risks of the registered substance to
fish, invertebrates and algae on the results of the available studies.
The average retention time of a substance in the WWTP is
approximately 12-24 hours. The presence of metals in sludge is likely to
catalyse the rate of hydrolysis resulting in the hydrolysis product
being the substance organisms will be exposed to in the environment.
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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