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EC number: 244-168-5
CAS number: 21041-95-2
According to regulation
(EC) 1907/2006 (REACH) a PBT and vPvB assessment shall usually be
conducted as foreseen in Article 14 (3) (d) in conjunction with Annex I
Section 4 and according to the criteria laid down in Annex XIII.
However, according to Annex XIII a PBT and vPvB assessment shall not be
conducted for inorganic substances.Cd(OH)2 is
an inorganic substance, thus a PBT and vPvB assessment is not required.
Still, the points below are raised:
Cadmium is an element and as such, the
criterion “persistence” is not applicable to Cd and Cd-compounds.
As an alternative for persistency (for
organic substances), the concept of “removal from the water column” has
been developed for inorganic elements.
In section 4.6 (of the CSR), the rapid
removal of cadmium from the water column is documented. So, cadmium can
be considered as equivalent to “degradable” and, consequently, does not
match in chronic toxicity terms with the criterion “persistent”.
Data on bioaccumulation of cadmium are
presented and discussed under section 4.3. From this analysis, the
following was concluded:
There is a number of data available on the
possible accumulation of cadmium in aquatic organisms.
BCF in fish (whole body data) are generally
below the criterion for considering a substance bioaccumulative.
Higher BCF /BAF factors are observed in the
lower levels of the food chain (algae notably). However, there are some
uncertainties with the data: the high BCF/BAF factors observed in the
algae are (at least partly) due to external absorption, not to uptake.
In general, algae data are not considered in a context of
bioaccumulation. The higher levels in invertebrates may be related to
lack of gut clearance of the organisms studied.
In terms of hazard
identification/classification, several considerations speak further
against considering Cd as bioaccumulative substance:
-the BCF/BAF values observed with Cd
consistently decrease with increasing exposure, which clearly shows some
level of physiological regulation of uptake. One of the key theoretical
conditions of the BCF model in terms of its relevance for chronic
toxicity and applicability to the hazard identification/classification
of chemicals is that the BCF/BAF should be independent of exposure. BCF/BAF
values should in other words remain fairly constant over a range of
exposures, which is clearly not the case for Cd.
-Evidence related to biomagnification in the
aquatic food chain consistently shows that Cd is not biomagnifying.
The data on terrestrial organisms show that
cadmium is not bioaccumulating in terrestrial organisms. Based on an
extensive review of evidence on a wide variability of taxonomic groups,
McGeer et al (2003) concluded that the BCF/BAF criteria, as conceived
for organic substances, are inappropriate for the hazard identification
and classification of metals, including Cd. They highlighted the
inconsistency between BCF/BAF values and toxicological data, as BCF
values are highest (suggesting hazard) at low exposure concentrations
and are lowest (indicating no hazard) at the highest exposure
concentrations, were toxicity is likely.
Considering the elements mentioned above,
cadmium and its compounds are considered as not bioaccumulative.
Related to secondary poisoning, the following
was concluded from the analysis in section 4.4.:
In the freshwater compartment,
the risk of secondary poisoning of fish eating birds by Cd is predicted
to be smaller than the direct effects of Cd in the aquatic environment. The
RA demonstrated, using BCF’s of fish (mentioned in section 4.3) that the
Cd concentration in whole fish at the PNECwaterof 0.19
µg Cd/l (section 7.) could be predicted to range between 0.0001 and 0.13
mg Cd/kg fresh weight using thewholerange of BCF’s (0.5-684 l/kg
fresh weight). It was concluded that these Cd concentrations were below
the PNECoralfor birds or birds+mammals (ECB 2007).
In the terrestrial compartment,
a PNEC for secondary poisoning was calculated from the lowest observed
PNECoralfor mammals and birds, which was derived from feeding
studies with Cd salt spiked diets. Nine
feeding studies were selected (sub-chronic and chronic studies), four
studies with birds and 5 studies with mammals. The
PNECoralof 0.9 µg Cd/g DW soil was calculated from the lowest
NOEC using an assessment factor (see section 7). It follows from the
risk characterisation under section10.2.2. (Environment (combined for
all emission sources), that the PNEC secondary poisoning is in general
not reached in soil.
The reference values for aquatic toxicity
following from section 7 are 18µg/l for acute toxicity, and 0.21 µg Cd/l
for chronic aquatic toxicity.
Summary and overall conclusions on PBT or
According to Annex XIII of regulation (EC)
1907/2006 (REACH) a PBT and vPvB assessment shall not be conducted for
inorganic substances. Cd is an inorganic substance, thus a PBT and vPvB
assessment is not required. Still, based
on the elements mentioned above, cadmium and its compounds are
considered as non-bioaccumulative and non-peristent.
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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