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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:
23-07-2012 to 03-08-2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Proprietary GLP study report.
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Specific details on test material used for the study:
Biphenyl-4,4’-diol / CAS 92-88-6
Key result
Water solubility:
33.7 mg/L
Temp.:
20 °C
pH:
6.5

Water Solubility Results at 20 °C for 4,4-Biphenol

 

Sample

Replicate No.

4,4-Biphenol
[mg/L]

Concentration2)

Mean

24 h

1

33.8

33.7

2

33.7

48 h

1

32.5

33.4

2

34.4

72 h

1

35.2

34.0

2

32.9

Mean (24 - 72 h)

 

 

33.7

Deviation [%]1)

  1.8

1)            Calculated according to Formula, Deviation (%) = 100 x (max value - min value) / min value.

2)            Mean value of two injections, dilution factor of 2 taken into account

The analytical method (HPLC-DAD, external standard) for the determination of the test item 4,4-Biphenol was validated and tested with satisfactory results in regard to linearity, accuracy, precision and specificity.

Conclusions:
The solubility of the test item was determined to be 33.7 mg/L (pH 6.5) at 20 +/- 0.5 °C. The substance is considered pratically insoluble (solubility < 0.1 g/L)
Executive summary:

The water solubility of 4,4-Biphenol was determined according to OECD guideline 105 (1995) and Council Regulation (EC) No. 440/2008, Method A.6 from 2012-07-23 to 2012-08-03 at Dr.U.Noack-Laboratorien, 31157 Sarstedt, Germany.

The decision for employing the flask method was based on preliminary testing (non GLP), where a solubility of approximately 10 mg/L was observed.

The solubility of the test item 4,4-Biphenol was determined using the flask method at 20 ± 0.5 °C with preincubation at 30 ± 0.5 °C.

The analytical method (HPLC-DAD, external standard) for the determination of the test item 4,4-Biphenol was validated and tested with satisfactory results in regard to linearity, accuracy, precision and specificity.

The water solubility of 4,4-Biphenol was determined to be 33.7 mg/L (20 °C, pH 6.5).

Description of key information

The solubility of the test item was determined to be 33.7 mg/L (pH 6.5) at 20 +/- 0.5 °C.

Key value for chemical safety assessment

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

Additional information