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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:
supporting study
Study period:
Experimental starting date: 16 February, 2015 to Experimental completion date: 11 August, 2020
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 36038/J TE Lot. 1404301
Appearance: Blue powder
Key result
Water solubility:
< 0.25 mg/L
Temp.:
20 °C
Remarks on result:
other: Without correction of the purity.

Preliminary Visual Estimation of the Water Solubility

Table: Appearance of the test mixtures in the preliminary test

Amount of the test item in mg

Total volume in ml

Appearance of mixture

 

10

undissolved

10

50

undissolved

 

100

undissolved

The preliminary visual experiments showed that the water solubility of the test item is below 100 mg/l.

Flask-Method

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

Experiment

A

B

C

D(blank)

Amount of test item(mg)

 500

 500

 500

 ---

Stirring time at 30°C (h)

 24

 48

 72

 72

Measured concentration (µg/ml)

n.d. (<0.25 µg/ml)

n.d. (<0.25 µg/ml)

n.d. (<0.25 µg/ml)

 

---

Aliquot

undiluted

undiluted

undiluted

undiluted

Water solubility (mg/l)

 < 0.25 mg/l

 < 0.25 mg/l

 < 0.25 mg/l

 ---

Average experiments A to C: < 0.25 mg/l

Table: Standard addition for recheck :

Standard

Measured concentration

(µg/ml)

% Recovery

Std4 + 5.05 µg test item

10.5

103.4

The recovery of 103.4 % indicates a sufficient accuracy of the analytical method.

Conclusions:
The water solubility of FAT 36038/J TE at 20 °C was determined to be <0.25 mg/l.
Executive summary:

The purpose of the study was determination of the water solubility of FAT 36038/J, according to the European Commission Regulation (EC) No.440/2008, A6. Water solubility , flask – method and OECD test guidelines OECD 105 water solubility were used to performed the experiment. Based on the findings of the study, the water solubility of FAT 36038/J TE at 20 °C was determined to be <0.25 mg/l.

Description of key information

The water solubility of FAT 36038/J at 20 °C was determined to be <0.8 mg/l.

Key value for chemical safety assessment

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

Additional information

The purpose of the study was determination of the water solubility of FAT 36038/J, according to the European Commission Regulation (EC) No.440/2008, A6. Water solubility , flask – method and OECD test guidelines OECD 105 water solubility. Since the test result demonstrated the test substance to be poorly water soluble, the test was repeated using the column elution method as recommended by the regulation. Based on the findings of the study using the shake flask method, the water solubility of FAT 36038/J at 20 °C was determined to be <0.25 mg/l. Based on the column elution method the water solubility was determined below the limit of detection at 0.8 µg/l. This value is further used for the calculation of the partition coefficient and used for the hazard and risk assessment.