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EC number: 807-130-4
CAS number: 53716-82-8
No terrestrial toxicity data are available with the
In accordance with Column 2 of REACH Annex X, there
is no need to further investigate the effects of Cyrene™ in a short- or
long-term terrestrial toxicity to invertebrates/higher plants study
because, as indicated in guidance R.7.11.6 (ECHA 2017), the quantitative
chemical safety assessment (conducted according to Annex I of REACH)
indicates that the Risk Characterisation Ratio is well below 1 and
therefore the risk is already adequately controlled and further testing
is not justifiable.
If Cyrene™ is released to water, the relevant form
of the substance under dilute environmental conditions, is the Gem Diol
(please refer to IUCLID Section 4, CSR Section 1.4 and the attached
report in Section 13 of IUCLID for further discussion on formation of
the Gem Diol). Due to water and moisture being present in soil, the Gem
Diol is the relevant form for the terrestrial compartment.
Cyrene™ is highly water soluble (measured water
solubility of ≥560 g/l; this value is applicable to both the Cyrene™ and
Gem Diol forms). Both Cyrene™ and its Gem Diol form have low potential
for bioaccumulation and low potential for adsorption based on log Kow
<3 (-1.52, measured; this value is applicable to both the Cyrene™ and
Gem Diol forms) and low log Koc (0.23, calculated based on
the log Kow)) and are readily biodegradable (measured data).
No toxicity was observed in short-term aquatic toxicity tests. Long-term
toxicity data predicted by QSAR estimates that effects would only occur
at extremely high concentrations, well in excess of the highest test
concentrations required by the relevant OECD test guidelines, and well
in excess of environmentally relevant concentrations.
There is no reason to expect any specific mechanism
of toxicity beyond narcosis. Therefore, the occurrence of more severe
toxic effects in the terrestrial compartment that were not expressed in
the aquatic studies would be considered unlikely. In addition, the
binding behaviour of the Gem Diol is not triggered by any other
mechanisms, for example it is not an ionising or surface active
substance, nor a substance that will bind chemically with soil
components. The aquatic compartment is therefore the most relevant and
aquatic toxicity data are available.
Cyrene™ and its Gem Diol form are classed as Hazard
Category 1 for the terrestrial environment (Table R.7.11-2 of ECHA
guidance R7.c, 2017) based on there being no indication for high
adsorption or high persistence of the substance in soil (the substance
is readily biodegradable) and no indication that the substance is very
toxic to aquatic organisms (EC/LC50 not <1 mg/l).
In this situation, the approach for screening assessment is to conduct a
PEC/PNEC screen based on the equilibrium partitioning method. If the
PEC/PNECscreen is <1, no toxicity testing for soil organisms needs to be
conducted. The PNECscreen(EQPM) for the Gem Diol is derived from the
algal NOEC, generating a PNECsoil value of 16 mg/kg dwt. Based on the
exposure assessment of the registered substance, the highest
PEC/PNECscreen(EQPM) for the Gem Diol is 9.36E-3.
Overall, it is concluded that the risk
characterisation conclusion is sufficiently conservative and therefore
further testing is not considered necessary.
In addition, there is very little difference in the
properties of the registered substance (Cyrene™) and the Gem Diol form,
therefore the assessment would not differ between the two forms.
Details on how the PNEC and the risk
characterisation ratio have been derived can be found in IUCLID Section
6.0 and Chapters 7, 9 and 10 of the Chemical Safety Report.
ECHA (2017). Guidance on Information Requirements
and Chemical Safety Assessment. Chapter R.7c: Endpoint specific
guidance. Version 3.0 June 2017.
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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