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EC number: 240-521-2
CAS number: 16470-24-9
No bioaccumulation is expected
According to the REACH Regulation, Annex
IX, Column 2, the substance does not need to be tested due to the low
potential for bioaccumulation (log Kow < 3) and a low potential to cross
biological membranes (high molecular weight, high polarity).
Nevertheless, several bioaccumulation
studies are available on the analogous substance CAS 13863-31-5 and they
demonstrated no bioaccumulation in fish. Bluegills (Lepomis
machrochirus) was exposed to the test item in dynamic flowthrough
tankwater systems, in order to determine at what degree this substance
accumulate in portions of the fish, which may be consumed by humans. The
concentration tested was 0.1 mg/l, the exposure period was 35 days and
the elimination phase was from 7 to14 days. During the tests, fish and
water were periodically sampled and analysed. A further accumulation
study using 14C-labeled substance was performed at concentrations of
0.01 and 0.001 mg/l; exposure phase was of 30 days, while elimination
phase of 14 days. Only sporadic trace concentrations (less than 0.05
mg/kg) of the test item were present in the fish at exposure levels of 1
mg/l. In most instances, no detectable substance was found.
The data indicates that there is no
tendency for the substance to be taken up and stored in the fish. In the
case of the 14C-substance, at both the concentrations tested, the levels
of radioactivity found in the fish were approximately equal to those
found in the tankwater throughout study. Furthermore the absence of
accumulated radioactivity demonstrated that neither parent compound, nor
possible metabolites of the substance are accumulated in fish (Ganz,
The test substance was also tested to
determine its potential for significant accumulation in the flesh of the
Bluegill (Lepomis macrochirus) and channel catfish (Ictalurus
punctatus). The test was conducted at the following concentrations: 50
µg/l, 5 µg/l, and 0.5 µg/l total test substances (the study was
conducted with five agents administrated in the same solutions). The
results of the bluegill analyses exposed to a nominal concentration of
50 µg/l total agents (12.5 µg/l of each one) indicate that no
accumulation of the substance of the interest was observed at measurable
levels (i.e., greater than 10 µg/kg). At the concentration of 5 and 0.5
µg/l(1.25 and 0.125 µg/l, respectively) no measurable accumulation was
detected (Sturm, 1974).
In the Bionomics Inc. and Ciba Geigy Ltd.
(1972-1973) study sixty Bluegill were continuously exposed to the
chemical in water for a period of at least 28 days. After this period,
the fish were transferred for a period of 7 days to uncontaminated water
and after this period they were sampled. Generally the test item
concentration were not determinable in tissues or were too low to be
quantified. In one case, a value of 0.03 mg/kg close to the sensitivity
limit (0.01 mg/kg) was measured, confirming that the bioaccumulation
potential of the test substance is considered negligible.
The CAS 13863-31-5 analogous substance is
the methyl/hydroxyethylamino derivative, disulphonated sodium salt,
member of the Stilbene Fluorescent Whitening Agents category. It is the
least water soluble among all the category members and thus it is
expected to be the member in which the absorption is the most favourite
process; this characteristic make it the most potentially
bioaccumulative and therefore the conservative preferred representative.
For completeness sake, the
Bioconcentration Factor (BCF) value was calculated using BCFBAF v3.01
tool, an application contained in the EpiSuite 4.1. The
estimation takes into account the substance is a ionic compound. The BCF
estimated value from regression-based method is 0.5 (BCF = 3.175 l/kg
wet-wt), in agreement with the common value of non bioaccumulative
is the suite of physical/chemical property and environmental fate
estimation programs developed by the EPA’s Office of Pollution
Prevention Toxics and Syracuse Research Corporation (SRC).
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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