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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:
Experimental start date - 16 September 2019; Experimental completion date - 12 October 2019; Study Completion Date - 22 October 2019.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
no
Type of method:
flask method
Specific details on test material used for the study:
Identification: FAT 75637/A TE
Lot.: BS-61
Appearance: Yellowish powder
Water solubility:
< 50 µg/L
Conc. based on:
test mat.
Temp.:
20 °C
Remarks on result:
other: pH not determined

Individual Results

Preliminary Visual Estimation of the Water Solubility

Table 1: Appearance of the test mixtures in the preliminary test

Amount of the test item in mg

Total volume in ml

Appearance of mixture

 

100

undissolved

10

1000

undissolved

The preliminary visual experiments showed that the water solubility of the test item is below 10 mg/l


 Flask-Method

 

Table 2: Water solubility of the test item – experiments A to D

 

Experiment

A

B

C

D(blank)

Amount of test item(mg)

 300

 300

 300

 ---

Stirring time at 30°C (h)

 24

 48

 72

 72

Measured concentration (µg/ml)

 < 50

  < 50

  < 50

 ---

Aliquot

undiluted

undiluted

undiluted

undiluted

Water solubility (mg/l)

  < 0.05

  < 0.05

  < 0.05

 ---

 

Average experiments A to C: < 0.05 mg/l

 

Table 3 : Standard addition for recheck :

 

Standard

Measured concentration

(µg/ml)

% Recovery

Fraction 4 + 250 μg/l test item

265

106

 

The recovery of 106 % indicates a sufficient accuracy of the analytical method.

 

Conclusions:
The water solubility of FAT 75637/A TE at 20 °C was determined to be < 50 μg/l
Executive summary:

The purpose of the study was determination of the water solubility of the test item according to the European Commission Regulation (EC) No.440/2008 and A6. Water solubility, flask – method and OECD test guidelines OECD 105 water solubility were used to perform the experiment. Shake flask method was used for this purpose.

Based on the findings of the study, the water solubility of FAT 75637/A TE at 20 °C was determined to be < 50 μg/l

Description of key information

The purpose of the study was determination of the water solubility of the test item according to the European Commission Regulation (EC) No.440/2008 and A6. Water solubility, flask – method and OECD test guidelines OECD 105 water solubility were used to perform the experiment. Shake flask method was used for this purpose. Based on the findings of the study, the water solubility of FAT 75637/A at 20 °C was determined to be <50 μg/l.

Key value for chemical safety assessment

Water solubility:
50 µg/L
at the temperature of:
20 °C

Additional information

The water solubility of FAT 75637/A TE at 20 °C was determined to be <50 μg/l.