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EC number: 430-150-6
CAS number: -
Table 6.1.3/1: Immobilisation
Rates after 24 and 48 h of Exposure
in the Definitive Test
= 20, divided into 4 replicates with 5 daphnids each
6.1.3/2: Measured Concentrations of the Test Item during the Definitive
Start of the exposure, 0 hours
End of the exposure, 48 hours
Date of analysis
test item concentration
conc. = measured concentration of the test item, dilution factor taken
= percent of the nominal concentration of the test item
= limit of quantification (1.00 mg/L of the test item)
- In the control group, no daphnids
were immobilised or showed any signs of disease or stress, e.g.
discoloration or unusual behaviour such as trapping on the surface of
the water, during the 48-hour test period (required: not more than 10
percent of the daphnids in the control).
was performed according to OECD Guideline 202 with GLP statement, to
assess the 48 h-acute toxicity of the of the test substance to Daphnia
magna, under static conditions.
item was exposed to daphnids at the concentrations of 16, 24, 36, 54 and
81 mg/L for 48 hours. The no-treatment control daphnids were exposed to
dilution water only. There were four replicates per treatment with five
daphnids per replicate, which provided a total of twenty daphnids per
each treatment and control group at test initiation. All test solutions
were prepared in dilution water. The test temperature was 19-20 °C. The
test item was expected to evaporate. To reduce losses of the test item,
the study was conducted in a closed system. The
tested solutions were clear throughout the exposure period. Before
definitive test, a 48-hour static range-finding test was conducted and
the percent immobilization was 0,
0 and 100% at 1, 10 and 100 mg/L, respectively.
concentrations of the test item were analytically verified via HPLC-UV
at the start of the exposure (0 hours) and at the end of the exposure
(48 hours) in all concentration levels and the control. The measured
concentrations of the test item at the start of the exposure (0 hours)
were in the range of 91 to 98 % of the nominal values. At the end of the
exposure (48 hours), the measured concentrations of the test item were
in the range of 83 to 91 % of the nominal values. The measured test item
concentrations were all within ± 20 % of the nominal concentrations.
This indicates that the test item concentrations were successfully
maintained for the duration of the test.The
water quality parameters (i.e. pH-value and dissolved oxygen
concentration), measured at the start (0 h) and at the end of the
exposure (48 h), were within the acceptable limits. The validity
criteria of the test guidelines were fulfilled.
of daphnids for the definitive test was 0, 0, 0, 30, 75 and 100 % (24
h); 0, 0, 5, 90, 100 and 100 % (48 h) at 16, 24, 36, 54 and 81 mg/L,
respectively. 24 and 48 h EC50 values were 43.3 mg/L (CI: 41.0 – 45.8)
and 30.3 mg/L (CI: 28.0-32.1).
EC50 -value of the reference item, potassium dichromate at 1.88 mg/L (Cl
1.62 - 2.19 mg/L) after 24 h was within the prescribed concentration
range of 0.6 - 2.1 mg/L.
No additional information
prediction was performed to assess the acute toxicity of the test
substance to daphnid. This QSAR has been validated to be compliant with
the OECD recommendations for QSAR modelling (OECD, 2004) and predicts
the endpoint value which would be expected when testing the substance
under experimental conditions in a laboratory following OECD Guideline
202. The criterion predicted was the EC50 (Median Effective
Concentration), a statistically derived concentration which is expected
to cause immobility in 50% of test animals within a period of 48 hours.
immobility of the daphnids was determined using a validated QSAR for the
Mode of Action in question, (MOA 1, non-polar narcosis). The QSAR is
based on validated data for a training set of 58 chemicals derived from
48-hour tests on daphnids, for which the concentrations of the test
substance had been determined by chemical analyses over the test period.
The water solubility of the
substance given as input was experimentally measured at 195 mg/L. The
substance falls within the applicability domain of the model as
demonstrated in the QPRF.
The 48-h EC50 value based on mobility
and measured concentrations was determined to be 9.2 mg/L with
95%-Confidence Limit between 8.4 and 10 mg/L.
OECD Guideline 202, GLP, key study,
48h-EC50 (Daphnia magna) = 30.3
mg/L (95% CL: 28.0 - 32.1 mg/L) based on analytically confirmed nominal
assess the short-term toxicity of the registered substance to aquatic
invertebrates, two data are available.
first study (NOACK, 2015) was assessed as the key study and was
performed on the registered substance according to OECD Guideline 202
with GLP statement. In
this study, the test substance was exposed to Daphnia magna at
the concentrations of 0 (control with dilution water only), 16, 24, 36,
54 and 81 mg/L for 48 hours, under closed system and static conditions
(four replicates per treatment; five daphnids per replicate). According
to the results of this study, the 48h-EC50 was determined at 30.3 mg/L (95%
CL: 28.0 - 32.1 mg/L), based on analytically confirmed nominal
second data (KREATiS, 2015), assessed as a supporting data, is a QSAR.
This QSAR prediction (iSafeRat holistic approach v1.4) was performed on
the registered substance, to assess the acute toxicity of the substance
to daphnids. This
QSAR has been validated to be compliant with the OECD recommendations
for QSAR modelling (OECD, 2004) and predicts the endpoint value which
would be expected when testing the substance under experimental
conditions in a laboratory following OECD Guideline 202. The immobility
of the daphnids was determined using a validated QSAR for the Mode of
Action in question, (MOA 1, non-polar narcosis). This QSAR is based on
validated data for a training set of 58 chemicals derived from 48-hour
tests on daphnids, for which the concentrations of the test substance
had been determined by chemical analyses over the test period. The
water solubility of the substance given as input was experimentally
measured (195 mg/L). The substance falls within the applicability domain
of the model. The 48h-EC50 value based on mobility and measured
concentrations was determined to be 9.2 mg/L (95% CL: 8.4 - 10 mg/L).
This QSAR result supports the key study performed on the same substance
with an EC50 value more conservative validating the model for use with
conclusion, according to the key
study (NOACK, 2015), the 48h-EC50 value on Daphnia magna is 30.3
mg/L (95% CL: 28.0 - 32.1 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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