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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:
From 13 June 2017 to 31 October 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
1995
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
2008
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: CY71353002
- Expiration date of the lot/batch: 01/06/2019
- Purity test date: 01/06/2017
- Purity of the test item: 99.8%
Key result
Water solubility:
> 10.68 - < 10.7 g/L
Incubation duration:
24 h
Temp.:
30 °C
pH:
> 2.88 - < 2.91
Key result
Water solubility:
> 10.89 - < 11.03 g/L
Incubation duration:
48 h
Temp.:
30 °C
pH:
> 2.88 - < 2.9
Key result
Water solubility:
> 10.82 - < 11.07 g/L
Incubation duration:
72 h
Temp.:
30 °C
pH:
> 2.88 - < 2.89
Details on results:
The peaks ratio in the test item samples in the definitive test are the following:
- diethyl succinate: 42.63 up to 43.70 %
- diethyl glutarate: 51.87 up to 52.87%
- diethyl adipate: 4.27 up to 4.62%

In the preliminary test, the test item water solubility was estimated between 10 and 50 g/l at 20°C.

The water solubility was determined using 6 samples analysed twice. The water solubility at 20°C is 10.9 g/l expressed in active ingredient and 11.1 g/l expressed in test item. The relative standard deviation associated with this results was 1.49%

Conclusions:
The water solubility at 20°C is 10.9 g/l expressed in active ingredient and 11.1 g/l expressed in test item. The relative standard deviation associated with this results was 1.49%
Executive summary:

The water solubility was determined with the shake flask method according to recognised guideline and under GLP. No deviation from the guideline was observed in the study.

The water solubility was visually estimated in a preliminary test. Then a definitive test using the shake flask method was performed.

The water solubility at 20°C is 10.9 g/l expressed in active ingredient and 11.1 g/l expressed in test item.

Description of key information

The water solubility of the test item was determined in a key study of Klimisch validity one, performed according to recognised guideline and under GLP.

Key value for chemical safety assessment

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

Additional information

The analytical method used for test item aqueous solution quantification is based on the signal of the three main components.