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EC number: 246-467-6
CAS number: 24801-88-5
Due to the rapid hydrolysis of the
substance, the chemical safely assessment is based on the silanol
hydrolysis product 3-aminopropylsilanetriol.
Testing for long-term toxicity to
fish is not considered necessary because:
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.188.8.131.52 (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:
The substance has acute data
available for three trophic levels, as well as chronic invertebrate and
algal toxicity data. Based on this available aquatic data the most
sensitive trophic level in the short-term tests was invertebrates, but
the most sensitive trophic level in the long-term tests was for algae.
Furthermore, no effects were observed in the short-term toxicity to fish
test even when the substance was tested at high nominal concentrations
approaching 1000 mg/l.
An assessment factor of 50 was
applied to derive the freshwater PNEC using the long-term algae result.
The availability of the long-term result covering the most sensitive
species in the aquatic tests, and the application of an appropriate
assessment factor, means it is, therefore, unlikely that the aquatic
PNEC would be significantly over-estimated. 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.
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,
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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