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EC number: 237-600-9
CAS number: 13863-31-5
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); furthermore
direct and indirect exposure of the aquatic compartment is unsuitable.
Several bioaccumulation studies are
available on the substance demonstrating no bioaccumulation in fish.
Bluegills (Lepomis machrochirus) have been
exposed in dynamic flowthrough tank-water systems to test item to
determine to what degree this product accumulate in portions of the fish
which may be consumed by humans. Test concentration was 0.1 mg/l. The
exposure period was 35 days and the elimination phase was 7 days. During
the tests, fish and water were periodically sampled and analysed.
Furthermore an 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 of the concentrations tested the levels of
radioactivity found in the fish were approximately equal to those in the
tank-water throughout the study. Furthermore the absence of accumulated
radioactivity demonstrated that neither parent compound nor possible
metabolites of the substance are accumulated in fish (Ganz, 1975).
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 analysesexposedto 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 will be transferred for a period of 7 to uncontaminated water
and after this period they were sampled. Generally the test item
concentrations 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.
For completeness sake, the estimation of
biodegradation using the BCFBAF v3.01 tool was performed.
The BCF estimated value from
regression-based method is 0.500 (BCF = 3.162 l/kg wet-wt), in agreement
with the common value of non bioaccumulable substances.
BCFBAF v.3.01 is an
application contained in the EpiSuite 4.1, 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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