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EC number: -
CAS number: -
No data on the Long term toxicity to aquatic invertebratesy of the
substance is available. The results from the structural analogue are
used instead (for details see reporting Format as attached to section 13
in the IUCLID dossier).
Two data are available.
In the first one (Safepharm, 1998), the
assessment of the effect of Reaction mass of tetrasodium
hexasodium-phosphonobutane-1,2,3,4-tetracarboxylate on the reproduction
of Daphnia magna was performedover a 21 day period. The method
followed that described in the draft OECD GL 211 and the GLP.
Daphnia magna were exposed (10
replicates of 1 daphnid per replicate) to an aqueous dispersion of the
test material over a range of test concentrations of 10, 32, 100, 320
and 1000 mg/L for a period of 21 days. The test solutions were
renewed 3 times per week. The numbers of live and dead adult Daphnia
were determined daily. The numbers of young Daphnia (live and
dead) were determined at each test media renewal. The Daphnia were
fed daily with a mixed algal suspension. The test was performed using
dechlorinated tap water with the hardness adjusted to approximately
80 mg/L as CaCO3.
Analysis of the freshly prepared test media
on day 0 and expired test media on days 2, 5, 7, 9, 12, 14, 16, 19 and
21 showed the measured test concentrations to be in excess of the
required 80% of nominal. It was therefore considered justifiable to
calculate the EC50 values in terms of the nominal test concentrations only.
Mortality (immobilisation) occurred within
the first 24 hours of exposure at the highest test concentration of 1000
mg/L. Significant mortality (immobilisation) also occurred during the
study in the 320 mg/L test group resulting in 100% mortality by day 18.
No mortality occurred at the 10, 32 and 100
mg/L test concentrations throughout the study.
After 21 days, there were no statistically
significant differences (P>=0.05) between the control and the 10, 32 and
100 mg/L test groups in terms of the number of young produced per adult
Consequently, the following effects
concentration were determined:
21 -Day EC50 (immobilisation) = 180 mg/L
(95% CL 100 -320 mg/L) (based on nominal test concentrations, for the
parental Daphnia generation (P1))
21 -Day EC50 (reproduction) = 180 mg/L (95%
CL 100 -320 mg/L) (based on nominal test concentrations)
21 -Day NOEC (immobilisation and
reproduction) = 100 mg/L.
The validity criteria of the OECD FGL 211
the method followed the OECD TG and GLP, this study is considered as
reliable and is selected as key study.
The second information available (Safepharm,
1997) is a preliminary study of the key study described above. It aimed
at the determination of the effect of the water hardness on reproduction
to Daphnia magna. For this, diluents of different hardness (i.e. 80, 150
and 250 mg/L as CaCO3) were used. The results were that exposure of
Daphnia magna to the test material of a test concentration of 10 mg/L
showed no effect on reproduction over a water hardness range of 80-250
mg/L as CaCO3. These results being consistent with the results of the
key study, it has been selected as supporting study.
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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