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EC number: 456-350-3
CAS number: 878665-13-5
fate and pathways:
described in the physical and chemical properties summary, the
registered substance is a liquid of very low water solubility and very
registered substance is not readily biodegradable but a strong and
consistent evidence of mineralisation was provided. Therefore, the
registered substance is inherently biodegradable (not fulfilling
specific criteria) and not persistent in the environment.
Delta-Damascone mercapto acetic acid (DD-ma) was identified as the
main degradation product. This compound is slowly degraded and in the
absence of other biodegradation study on this metabolite, DD-ma is
considered as potentially persistent (P) or very persistent (vP).All
larger metabolites found can be considered as transient intermediates.
the bioaccumulation potential, with a measured log Kow value at 9.5,
the registered substance would not be expected to bioaccumulate
significantly. This statement was confirmed with an experimental
bioaccumulation study, performed for a Japan notification on the
registered substance, and showing a BCF value lower than 38. The
registered substance is not considered as bioaccumulable. Also, the
final degradation product of the registered substance, DD-ma, is not
expected to bioaccumulate significantly in the environment with a log
Kow at 3.1 (arithmetical mean value of QSAR results).
the adsorption coefficient (Koc) of the registered substance was
estimated by the KOCWIN v2.00 model to be 1953500 L/kg (log Koc =
6.3), using an experimental log Kow value at 9.5, indicated that the
registered substance is immobile in soil(according
to P.J. McCall et al., 1981).
data, reliable with restrictions (Klimisch rating), based on
international guidelines, are available to assess the toxicity of the
registered substance to the three trophic levels: Algae, Invertebrates
the very low water solubility of the substance, it's technically not
feasible to obtain a relevant endpoint value. The substance had no
acute toxic effects on aquatic organisms up to and significantly
higher than its solubility limit in test water.
addition, according to the supporting acute toxicity study on Daphnia
magna (Fraunhofer, 2013), the total lack of reproducibility within
the various replicates and concentration levels demonstrates that it
is not technically feasible to dissolved the substance in solution and
to obtain reliable concentrations. Therefore, it is not possible to
conduct a chronic Daphnia test and moreover aquatic toxicity
tests in general are not likely to be technically feasible for this
As a strong and consistent
evidence of mineralisation of the registered substance was
provided, the acute toxicities of the degradation products,
which are the relevant species for the environmental risk
assessment, were determined using the ECOSAR v1.11 QSAR
model available from the U.S. EPA. The assessed degradation
products were Delta-Damascone mercapto acetic acid (DD-ma)
(which is the main degradation product) and two other larger
metabolites (Delta-Damascone mercapto proprionic acid
(DD-mp) and Delta-Damascone (DD)).
degradation products are presumably not toxic (T) in a PBT assessment
registered substance was considered as non-toxic to the microorganisms
of a water treatment plant (3h-EC50 > 1000 mg/L).
Two reliable key studies are available to
assess the toxicity of the registered substance to earthworm. The
first study (Harlan, 2011) assess the acute toxicity effects using the
filter paper contact test according to OECD Guideline 207 and the
second study (Fraunhofer, 2015) assess the chronic toxicity effects
according to OECD Guideline 222.
In the second study (Fraunhofer, 2015), no
increased mortality and no significant influence on weight change were
found up to the maximum tested concentration, 1000 mg/kg dry soil.
However, reproduction was significantly affected starting at 125 mg/kg
dry soil. The NOEC for reproduction was found to be 62.5 mg/kg dry
soil and the EC10 was found to be 116 mg/kg dry soil (95 % CL: 45 –
185 mg/kg dry soil). As NOECs are increasingly contested in
ecotoxicology because it's not a statistically interpolated value, the
EC10 value at 116 mg/kg dry soil is prefered to assess the chronic
In conclusion, the test substance has no
acute effects on earthworm but has chronic effects, based on
reproduction, under the chosen test conditions. The relevant chronic
value is defined as the EC10 at 116 mg test substance/kg dry soil (95
% CL: 45 – 185 mg/kg dry soil).
Based on the very
low water solubility of the registered substance, it's technically not
feasible to obtain a relevant aquatic endpoint value. The substance had
no acute toxic effects on aquatic organisms up to and significantly
higher than its solubility limit in test water. The long-term toxicity
effects cannot be evaluated. The
substance is not readily biodegradable but is not considered
bioaccumulative based on a log Kow at 9.5 and the ongoing experimental
bioaccumulation study (BCF < 50).
according to the Annex VI of the Regulation (EC) No 1272/2008 (CLP):
The registered substance is not
classified for the environment.
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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