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EC number: 257-077-0
CAS number: 51240-95-0
Definitive test results
No mortality up to 46 mg/L (loading) equal to 6.62 mg/L (measured
GLP study containing three separate tests , to appropriate guideline.
Tests conducted above the water solubility limit resulting in non
relevant physical effects. In light of new solubility data relevant
conclusions can be drawn however.
10 mg/L loading (that typically generates a dissolved concentration of
up to 36µg/L measured in GLP studies) no differences to the negative
controls was observed based on any of the criteria set in the test
GLP studies using the same preparation techniques have demonstrated that
due to WAF being loaded far in excess of its water solubility limit that
the soluble fraction of the parent material remains present despite the
soluble fraction itself being instable. The daily refreshment of the
test wells will have ensured the maximum possible exposure to the test
substance over the test period.
soluble fraction of the test substance can be concluded as non-toxic to
zebra fish embryos at its maximum achievable solubility in test medium
in a semi static 96 hour test with daily refreshment.
A non GLP test was performed in accordance
to OECD 236. Due to the low water solubility of the parent, the embryos
were exposed to a WAF as desribed in the RSS. A loading of 10 mg/L test
material did not result in any significant differencies to Danio rerio
embryos. The soluble fraction of th test substances can therefore be
concluded as non-toxic to zebra fish embryos at its maximum achievable
solubility in the test medium in a semi static 96 hour test with daily
Analogous substance CAS 22288 -41 -1 showed
no toxicity up to the maximum water solublity, therefore LL50 > ws. a
FET (OECD 236) was performed with CAS 22288 -41 -1 and the registered
substance to show similarity and to strengthen the read across. A
loading of 10 mg/L test material did not result in any significant
alterations to Danio rerio embryos for both substances. This
concentration is far above the waters solubility of the substance. The
results support that the substance is unlikely to be toxic to fish.
A short-term toxicity study according to
OECD 203 with 1,1,3,3-tetramethylbutyl peroxypivalate (CAS 22288-41 -1)
is available showing no toxicity up to the water solubility limit.
A fish embryo test with the similar
substance 1,1,3,3-tetramethylbutyl peroxypivalate (CAS 22288-41 -1) and
the registered substance (CAS 51240 -95 -0) was performed as supporting
evidence for read across.
A non GLP test was performed according to
the fish embryo acute toxicity (FET) test, OECD 236, adopted 26 July
2013. A stock solution in the standard manner was not possible with this
material due to the poor solubility of the test substance and likely
hood of degradation products being formed. For this
reason a WAF approach was used, as described in the RSS, to allow
stabilization at the water solubility limit of the parent substance and
any other water soluble degradation components that may accumulate
during the stirring period. GLP studies had indicated that 6 days
stirring was sufficient to measure an increase in the main degradation
product and still maintain the parent material at its solubility limit.
Test solutions were refreshed daily.
A loading of 10 mg/L test material did not
result in any significant effects to Danio rerio embryos. The
soluble fraction of the test substances can therefore be concluded as
non-toxic to zebra fish embryos at its maximum achievable solubility in
the test medium in a semi static 96 hour test with daily refreshment.
Conducting a new fish test would not add any
new information for either classification or risk assessment, and hence,
the study is waived.
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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