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EC number: 939-457-4
CAS number: 1469983-50-3
1- VALIDATION OF THE
The biological control samples and
an analyzed analytical blank (test media) did not affect the
chromatogram at the retention time of the test item. The calibration
solutions contained a peak specific for the test item, whose area
changed accordingly with known concentration.
- An example of calibration data
for the calibration solutions of the test item is given in
figure 1 (calibration plot) and in the following table :
Nominal concentration of test item
Fitted concentration of test item
Deviation of the fitted value from the nominal value
The R2 fit of the calibration
curves used were 0.9985, 0.9979 and 0.9985. This reflects the linearity
of the analytical system within the calibration range of 1.04-15.3mg
- Accuracy (recovery) and
Concurrent with the sample
analyzis, a set of recovery samples accurately forftified at relevant
concentrations of the test item (1.93 mg and 14.1 mg test item/L)
was prepared five-fold and analyzed. The results obtained for the
concentrations of the test item in the recovery samples are presented in
the following table :
Measured concentration of test item in the Spiked sample
Sample preparation factor
Concentration of test item determined in the spiked sample
Accuracy (Average Recovery)
Precision (Relative standard deviation of recovery)
Acceptance Target :
The average recoveries were found
to be 105% and 110% of the spiked values with relative standard
deviations of 5% and 4%, respectively. The method was considered to be
sufficiently accurate and precise for the purposes of this test. The
test sample results were not corrected for recovery.
- Limit of quantification
The limit of quantification (LOQ)
for the test item in the test samples was derived from the lowest
calibration solution, which fits into the calibration curve. The LOQ is
1.04mg test item/L.
2- ANALYTICAL RESULTS
The results obtained for the
concentrations of the test samples are presented in the following table
Measured concentration of test item
Determined concentration of test item
% of nominal concentration
The concentrations as % nominal
found in the fresh test samples were 110% and 108% (day 0), 110% (day 7)
and 110% (day 16).
The concentrations as % nominal
found in the old test samples were 90% and 104% (day 2/48h), 57%
and 52% (day 2/48h, with feed), 108% (day 9/48h), 33%
(day 9/48h, with feed), 43% (day 19/72h) and 33% (day 19/71h, with
Remark : in the stability control
samples including food particles the mean test item concentrations had
further decreased to 33 -57%
of the nominal values. Thus , a part of the test item had obviously
adsorbed onto the food particles. However, since filter feeding test
animals as Daphnia may take up the test item also from ingested food,
the decrease of the test item concentrations in the test media due to
adsorption onto food is not taken into account. Therefore, the
biological results are based on mean measured test item concentrations
(calculated as the time-weighted means over all measurements per test
concentration without food (3.2 mg/L, three intervals) or as geometric
mean (10 mg/L, one interval since all daphnids qere dead at day 5)).
The time weighted means (nominal 3.2 mg/L) were
calculated according to the equation indicated in the OCED guidelines.
Samples with food :
Total days : 7
Total area : 15.347
Time-weighted mean : 2,2mg/L
% of nominal : 69%
Samples without food (used for appraisal of the biological results) :
Total days : 7
Total area : 20.198
Time-weighted mean : 2,9 mg/L
% of nominal : 90%
The geometric means (nominal 10 mg/L) were calculated according
to the equation indicated in the OCED guidelines.
Samples with food : 7.5 mg/L
Samples without food (used for appaisal of the biological
results) : 10.6 mg/L
The chronic toxicity of the test item (= substance EC 939-455-3 in
aqueous commercial product) to the freshwater crustacean species Daphnia
magna was investigated in a GLP-compliant study performed in
accordance with OECD Guideline 211 and EU Method C.20 (Daphnia magna Reproduction
Test). The 21-day NOEC (survival and reproduction) was found to be 2.9
mg/L (corresponding to 1.39 mg solid content/L and 1.05 mg active
content/L) based on measured concentrations.
As the chronic toxicity to aquatic invertebrates of the substance EC
939-457-4 has not been investigated experimentally, a read-across
approach was followed to fill in the endpoint. The chronic toxicity to
the freshwater crustacean species Daphnia magna of a structural
analogue substance (= source substanceEC
939-455-3) was investigated in a GLP-compliant study (Höger,
2013) performed in accordance with OECD Guideline 211 and EU Method C.20
(Daphnia magna Reproduction Test). The 21-day NOEC (survival and
reproduction) was found to be 1.39 mg solid content/L. By analogy, the
same NOEC value was reported for the target substance 1-Propanaminium,
numbered) acyl) derivs., hydroxides, inner salts (EC 939-457-4).
The chronic toxicity to aquatic
invertebrates of the structural analogue substance (= source substance
EC 939-455-3) was investigated in a GLP-compliant study (Höger, 2013)
performed in accordance with standard methods, without deviations. The
study is considered as reliable (Klimisch 1) and was selected as key
study for the endpoint of the target substance EC 939-457-4.
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.
Tällä verkkosivustolla käytetään evästeitä parhaan mahdollisen käyttäjäkokemuksen varmistamiseksi.
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