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EC number: 266-582-5
CAS number: 67124-09-8
General considerations for aquatic
The preparation of Water Accommodated
Fractions (WAFs) was performed for all aquatic toxicity experiments
since the test material possesses only a slight water solubility (4.84
mg/L at 20 °C, Woolley and Mullee, 2003). This procedure is in
accordance with the OECD Guidance document on aquatic toxicity testing
of difficult substances and mixtures (Series on testing and assessment -
Number 23; OECD, 2000). The term WAF is applied to aqueous media
containing only the fraction of multi-component substances that is
dissolved and / or present as a stable dispersion or emulsion. These
fractions are prepared individually and not by serial dilution of a
single stock WAF. As the term indicates, only a fraction of the total
mass of multi-component substances responsible for the composition of a
WAF may be present in the WAF. The "loading rate" is the mass to volume
ratio of the mixture to medium used in the preparation of a WAF. The
obtained LL50 / EL50 values are comparable to LC50 / EC50 values, as
well as the NOELR (No Observable Effect Loading Rate) to NOEL (No
Observable Effect Concentration).
Acute toxicity to fish
Two experimental results are available,
which are reliable without restrictions (Klimisch 1). The tests were
conducted according to OECD Guideline 203 (EU Method C.1) with
certificated GLP compliance. Rainbow trout (Oncorhynchus mykiss)
were used as test organisms.
Considering the definitive test of the key
study, the highest loading rate resulting in 0 % mortality was
determined to be 0.56 mg/L loading rate WAF, the lowest loading rate
resulting in 100 % mortality to be 1.0 mg/L loading rate WAF (Sewell,
2004). The LL50 was determined as 0.75 mg/L with 95 % confidence limits
of 0.56 - 1.0 mg/L. The No Observed Effect Loading Rate (NOELR) was
sought to be 0.56 mg/L loading rate WAF.
In the supporting study, at the the time
point of 24 h all fish were dead testing the nominal loading rate of 10
mg/L (Sewell, 2004). The LL50 was determined as 0.42 mg/L with 95 %
confidence limits of 0.32 - 0.56 mg/L. The No Observed Effect Loading
Rate (NOELR) was thought to be 0.32 mg/L loading rate WAF.
Chronic toxicity to fish
No data on the long-term toxicity to
fish are available for this substance. In short-term tests the water
flea demonstrated equivalent sensitivity to the test substance as
compared to the fish, and given that the chronic water flea study covers
the complete life cycle of the organism it was deemed sufficient to
characterize the long term endpoint for aquatic organisms along with the
chronic algae results.The procedure is
in accordance to Regulation (EC) 1207/2006 (REACH), Annex IX, Section
9.1.6, column 2.
Acute toxicity to aquatic invertebrates
reliable Guideline studies (OECD Guideline 202) with certificated GLP
compliance can be reported concerning short-term toxicity towards Daphnia
In the key
EC50 value was determined to be 0.58 mg/L loading rate WAF with 95 %
confidence limits of 0.51 - 0.66 mg/L (Goodband and Mullee, 2011). The
corresponding No Observed Effect Loading Rate (NOELR) is 0.32 mg/L.
supporting study report gives an EC50 value of 1.3 mg/L loading rate WAF
with 95 % confidence limits of 1.0 - 1.8 mg/L. The corresponding No
Observed Effect Loading Rate (NOELR) is 1.0 mg/L.
both cases, no
evidence of undissolved substance was observed, since microscopic
inspection of the WAFs showed no micro-dispersions or undissolved test
item to be present. The solutions were not renewed during the exposure
period. The differences were given in the used test concentrations, in
the key study test concentrations of of
0.1, 0.18, 0.32, 0.56 and 1.0 mg/L nominal loading rate WAFs were used,
whereas in the supporting study concentrations
of 1.0, 1.8, 3.2, 5.6, 10, 18, 32, 56 and 100 mg/L nominal loading rate
WAFs were tested.
toxicity to aquatic invertebrates
Daphnia magna was used as test
organisms to investigated the chronic toxicty to aquatic invertebrates
of the test material according to OECD Guideline 211(Wetton,
2003). The 14 and 21-Day EL50 (immobilisation) value, based on
nominal loading rates, for the parental Daphnia generation (P1) was
calculated to be 0.75 mg/L loading rate WAF with 95 % confidence limits
of 0.56 – 1.0 mg/L loading rate WAF. The 21-Day EL50 (reproduction)
value based on nominal loading rates was calculated to be 0.50 mg/L
loading rate WAF with 95 % confidence limits of 0.39 – 0.63 mg/L loading
rate WAF. The "Lowest Observed Effect Loading Rate" was considered to be
0.56 mg/L on the basis that at this test concentration significantly
fewer live young per adult (P < 0.05) were produced when compared to the
control. The "No Observed Effect Loading Rate " was considered to be
0.32 mg/L on the basis that at this test concentration there were no
mortalities (immobilisation) observed in the parental generation (P1)
and that there were no significant differences (P ≥
0.05) between the control and the
0.32 mg/L loading rate WAF test group in terms of numbers of live young
produced per adult by Day 21.
Toxicity to aquatic algae
The growth inhibition effect of the test
substance to Desmodesmus subspicatus was investigated according
to OECD Guideline 201with GLP compliance statement (Mead, 2004). An
Effective Loading rate, EL50 greater than 100 mg/L loading rate WAF and
the corresponding No Observed Effect Loading Rate of 100 mg/L is
reported. It was considered unnecessary and unrealistic to test a
loading rate in excess of this test concentrations.
Toxicity to microorganisms
Activated sludge was used in a static
freshwater experiment with an exposure time to the test substance of 3
hours in accordance to OECD Guideline 209 (Goodrich, 1994). None of the
test concentrations (1, 10, 100, 1000 and 10000 mg/L) produced an
inhibition greater than 50 %, consequently an EC50 could not be
calculated. Hence the EC50 is > 10,000 mg/L.
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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