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EC number: 217-164-6
CAS number: 1760-24-3
Testing for long-term toxicity to fish is not considered necessary
In accordance with Column 2 of REACH Annex IX, there is no need to
further investigate the effects of this substance in a long-term aquatic
toxicity to fish study because, as indicated in guidance R.184.108.40.206 (ECHA
2016), the quantitative chemical safety assessment (conducted according
to Annex I of REACH) indicates that further testing is not justified for
the following reasons:
A PNEC has been derived for the purpose of chemical safety assessment
and the risk characterisation ratios are below 1.
The substance is highly water-soluble, has low bioavailability based on
log Kow <3 (-4.0 (corrected for ionisation)), especially in
pH neutral conditions, and evidence from data available within the
analogue group of amine substances suggests that fish are the least
sensitive trophic level.
The substance has short-term data available for three trophic levels, as
well as long-term invertebrate toxicity data. Based on this available
aquatic data the most sensitive trophic level is algae which is more
toxic by a factor of two to three hundred. Furthermore, effects
observed in the short-term toxicity to fish test occurred when the
substance was tested at high concentrations, well above 100 mg/l.
Overall it is concluded that the risk is adequately assessed using the
short-term data and the long-term invertebrate test, and that in vivo
testing on vertebrate animals is not considered necessary or justified
on ethical grounds.
Details on how the PNEC and the risk characterisation ratio have been
derived can be found in IUCLID Section 6.0 and Chapters 9 and 10 of the
Chemical Safety Report, respectively.
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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