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Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018-02-12 to 2018-02-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
GLP compliance:
no
Type of method:
column elution method
Key result
Water solubility:
< 0.53 mg/L
Conc. based on:
test mat. (dissolved fraction)
Incubation duration:
2 h
Temp.:
20 °C
pH:
7.3

RUN 1: Regarding fractions 06 to 15 all solubility values were below the LOQ of the method. Average solubility: <0.53 mg/L (RSD not applicable)

Table 1: Column elution method, Run 1 (25 mL/h); Test material used for coating: 56.04 mg

 Fraction no.  Approx. volume (mL)  pH  Cs (mg/L)
  Fraction 06  14.0  7.6   <0.53
  Fraction 07  14.0  7.7   <0.53
  Fraction 08  14.5  7.6   <0.53
  Fraction 09  14.0  7.5   <0.53
  Fraction 10  15.0  7.4   <0.53
  Fraction 11  14.0  7.4   <0.53
  Fraction 12  14.0  7.4   <0.53
  Fraction 13  14.5  7.3   <0.53
  Fraction 14  14.0  7.4   <0.53
  Fraction 15 14.0  7.4   <0.53

Run 2: Regarding fractions 06 to 15 all solubility values were below the LOQ of the method. Average solubility: <0.53 mg/L (RSD not applicable)

Table 2 Column elution method, Run 2 (12.5 mL/h); Test material used for coating: 49.30 mg

Fraction no.  Approx. volume (mL)  pH  Cs (mg/L)
  Fraction 06  13.0  7.1   <0.53
  Fraction 07  13.5  7.2   <0.53
  Fraction 08  14.0  7.1   <0.53
  Fraction 09  14.0  7.1   <0.53
  Fraction 10  14.0  7.2   <0.53
  Fraction 11  15.0  7.2   <0.53
  Fraction 12  14.0  7.0   <0.53
  Fraction 13  14.5  7.1   <0.53
  Fraction 14  14.5  7.1   <0.53
  Fraction 15 14.5   7.1   <0.53

The determined water solubilities for both runs are considered to be in accordance since all measured values were below the LOQ of the method. At the end of each column elution experiment, there was still enough test item left on the surface of the glass beads at the end of all runs. There were no visible changes in the coating during the runs.

Conclusions:
The water solubility of the test item was found to be <0.53 mg/L at pH 7.3 and a temperature of 20 °C.
Executive summary:

The water solubility of the test item was determined in distilled water according to the "column elution method" described in the European Commission Council regulation (EC) No 440/2008, Annex, Part A, A.6, OECD-guideline 105 and the EPA Product Properties Test Guideline OCSPP 830.7840 and found to be <0.53 mg/L at pH 7.3 and a temperature of 20 °C.

Description of key information

The water solubility of the test item was found to be <0.53 mg/L at pH 7.3 and a temperature of 20 °C.

Key value for chemical safety assessment

Water solubility:
0.53 mg/L
at the temperature of:
20 °C

Additional information

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