Registration Dossier
Registration Dossier
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EC number: 268-092-7 | CAS number: 68002-78-8 This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated trialkyl carboxylic acid trimethylolpropane triester and SDA Reporting Number: 11-015-00.
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
The chemical safety assessment according to Annex I of Regulation (EC) No. 1907/2006 does not indicate the need to investigate further the long-term toxicity to fish.
Key value for chemical safety assessment
Additional information
Experimental
data on the long-term toxicity of Fatty acids, C16-18 and C18-unsatd.,
triesters with trimethylolpropane (CAS 68002-78-8) to fish are not
available. According to Annex IX of Regulation (EC) No 1907/2006
long-term toxicity tests on fish do not need to be conducted if the
chemical safety assessment of a substance indicates the no need for a
further investigation of the effects on fish. The substance does not
meet the criteria for classification according to Directive 67/548/EEC
or Directive 1999/45/EC and is not assessed to be a PBT or vPvB. The
assessment is based on the results of short-term toxicity indicating a
low potential for aquatic toxicity.
According to the Guidance on information requirements and chemical
safety assessment Chapter R.7b: Endpoint specific guidance, R.7.8.5.3
(ECHA, 2012), long-term testing of fish should only be conducted if it
represents the most sensitive taxonomic group. The Guidance states that
if invertebrates are likely to be more sensitive than fish and algae or
the relative sensitivity of invertebrates cannot be predicted, long-term
testing on Daphnia sp. should be preferred instead of fish. The acute
toxicity testing demonstrated no toxic effects of Fatty acids, C16-18
and C18-unsatd., triesters with trimethylolpropane (CAS 68002-78-8) to
fish. Since fish cannot be identified as the most sensitive organism, a
long-term test on Daphnia magna was conducted as recommended by the
Guidance document. Testing according to OECD guideline 211 demonstrated
no toxic effects of the substance on survival and reproduction of
Daphnia magna up to the limit of water solubility (NOELR (21 d) ≥ 0.11
g/L) (Grell, 2013).Based on the available data long-term toxic effects
of Fatty acids, C16-18 and C18-unsatd., triesters with
trimethylolpropane (CAS 68002-78-8) on fish are not to be expected.
Therefore and for reasons of animal welfare, long-term testing on fish
is not proposed.
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.
