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EC number: 242-893-1
CAS number: 19223-55-3
The CMC was determined from the intersection of the two trend lines y1
and y2. Trendline y1 was obtained using the data of the test solutions
with test item concentrations of 1, 10, 40, 70, 100 and 201 mg solids/L.
Trendline y2 was obtained from the mean surface tension of the test
solutions with test item concentrations of 503, 1003, 3998, 7008 and
10008 mg solids/L. The intersection was calculated to be at a log C
value of 2.60. It corresponded with a CMC of 402 mg solids/L (equivalent
to a CMC of 809 mg test item/L).
The Critical Micelle Concentration (CMC) of the substance
EC 939-455-3 (freeze-dried) in aqueous commercial product) was
determined in a GLP-compliant study by measuring the surface tension of
test item solutions at different test item concentrations. The CMC of
the test item was 809 mg/L, equivalent to a CMC of 402 mg solid
Preliminary test results
Through the serial volume addition of water to the test item, it was
shown that the water solubility of the test item was estimated to be
higher than 200 g/L at 20 ± 1.0 °C. Based on this result, it was decided
to made the main test with water at a concentration of 500 g/L.
Main test results
The following table show the data used for the determination of the
The calibration curve used for the determination of the test item
concentration in the analytical solutions was equal to :
Peaks area = 94709 * (C in mg/l) + 56748
The following concentrations were obtained in the solutions prepared for
the hydrosolubility determination:
pH was taken at 20°C
The mean results are summarized in the following table
The observed mean concentration of test item is equal to 556 g/L with an
RSD of 2.1% using starting solutions obtained with about 10 g of test
and 10 mL of water.
The water solubility of the
substance EC 939-455-3 (freeze-dried) was investigated in a
GLP-compliant study performed in accordance with OECD Guideline
105 (Water Solubility) and EU Method A.6 (Water Solubility). The
solubility of the test item in water was found to be higher than 500 g/L
at 20.0 ± 1.0 °C. The experimental value obtained is equal to 556 g/L
using starting solutions obtained with about 10 g of test item and 10 mL
of water. The analytical method used for the test was validated on the
basis of the most important constituent represented by the C12 fraction
in the test item.
As the water solubility of the REACh substance
amino]propyl]ammonium hydroxide (EC 242-893-1) has not been determined
experimentally, a read-across approach was followed to fill in the
endpoint. The water solubility of a structural analogue substance (=
source substance EC 939-455-3, C8-18 AAPHS) was investigated in a
GLP-compliant study (Ricau, 2013) performed in accordance with OECD
Guideline 105 (Water Solubility) and EU Method A.6 (Water Solubility).
The solubility of the analogue substance was 556 g/L at 20.0 ± 1.0 °C.
By analogy, a water solubility of 556 g/L at 20.0 ± 1.0 °C is reported
for the target substance (2-Hydroxy-3-sulphopropyl)
dimethyl[3-[(1-oxododecyl) amino]propyl]ammonium hydroxide (EC
242-893-1, C12 AAPHS).
In addition, the Critical Micelle Concentration (CMC) of the structural
analogue substance (= source substance EC 939-455-3, C8-18 AAPHS) was
determined in a GLP-compliant study (Maire, 2018) by measuring the
surface tension of test solutions at different test concentrations. The
CMC was 402 mg solid content/L. By analogy, a CMC of 402 mg solid
content/L is reported for the target REACh substance (EC 242-893-1, C12
The alkyl C-chain distribution of the source substance EC 939-455-3
significantly overlaps with the one of the target substance EC
242-893-1, the C12-alkyl derivative being the major constituent in both
chemicals. The structural differences in side C-chains is not expected
to lead to significant differences on phys-chem properties.
The water solubility and Critical
Micelle Concentration of the structural analogue (= source substance EC
939-455-3) were investigated in GLP-compliant studies (Ricau, 2013;
Maire, 2018) performed in accordance with standard methods, without
deviations. The studies are considered as reliable (Klimisch 1) and were
selected as key studies for the endpoint of the target substance EC 242-893-1.
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