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Physical & Chemical properties

Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06-11 February 2014
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was conducted according to an internationally recognised method, and under GLP, but with deviation on loading rate. The substance is adequately characterised. Threfore validation applies with restrictions.
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
1995
Deviations:
yes
Remarks:
loading rate >> 5x preliminary
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
Regulation (EC) No 440/2008
Deviations:
yes
Remarks:
loading rate >> 5x preliminary
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. QA statement)
Remarks:
inspected on June 3 to 5, 2013 / signed on November 5, 2013
Type of method:
flask method
Specific details on test material used for the study:
STORAGE CONDITIONS OF TEST MATERIAL
6 ± 2 °C, protected from light, under nitrogen in the original container
Key result
Water solubility:
2.16 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
125 g/L
Incubation duration:
72 h
Temp.:
20 °C
pH:
4.1
Details on results:
The analytical method was validated and tested with satisfactory results in regard to linearity, accuracy, precision and specificity:
System quantification limit = 5 mg/L
Limit of Quantification = 200 mg/L.
Linearity
Range: 5 – 200 mg/L with r2 = 0.99989 (n=7)
Accuracy
Recovery rates were 91% for the 1 x LOQ (RSD=5.0%) and 101 % for the 10 x LOQ (RSD=0.32 %).
Specificity
The analyte spectra of the samples matched with standard spectra with sufficient confirmation of identity. Response of blank values of control samples was significantly lower than 30% of LOQ.

Table 4.8/1: Water Solubility Results at 20 °C

 

Preincubation time

Replicate

No.

Test item (mg/L)

Concentration1

Mean

24 h

1

2158

2180

2

2201

48 h

1

2175

2158

2

2141

72 h

1

2137

2140

2

2144

Mean (24 - 72 h)

2159

Maximum deviation [%] (24 - 72 h)

1.9

 

1Mean value of triplicate samples each double injected; mean value of duplicate samples for replicate 1 at 72 h due to an identified outlier (GRUBBS-test)

Tyndall effect was negative for all samples. Measured pH was 4.1 for all samples.

Conclusions:
Soluble (> 1 g/L).
Executive summary:

The water solubility of the test substance was measured under GLP according OECD 105 / EU A6 guideline, using the flask method, in double distilled water, at 20°C with preincubation at 30°C. Three measurements were performed at 24, 48 and 72 h, with duplicate analysis.

The analytical method (HPLC-DAD, external standard) for the determination of the test substance was validated and tested with satisfactory results in regard to linearity, accuracy, precision and specificity.

Equilibrium was considered achieved at first sampling interval (24h).

 

The water solubility of the test substance was determined to be 2.16 g/L (20°C, pH 4.1).

Description of key information

Soluble, with rapid dissolution (equilibrium reached <=24h). pH of saturated solution: 4.1.

Key value for chemical safety assessment

Water solubility:
2.16 g/L
at the temperature of:
20 °C

Additional information

A reliable experimental study, conducted according to a recognized OECD/EC method and under GLP, is available. Despite deviation on testing conditions, it is considered as a key study. The result is retained as key data