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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:
2018-01-29 to 2018-04-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
1995
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
2008
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
flask method
Key result
Water solubility:
37.6 mg/L
Conc. based on:
test mat.
Incubation duration:
>= 48 - <= 72 h
Temp.:
20 °C
pH:
5.3

Table 2: Results of the preliminary test

phase separation procedure

Meass. Conc. [mg/L]

Replicate 1

Replicate 2

centrifugation

10000 x g for 10 min

72.2

76.9

20000 x g for 20 min

69.3

74.0

filtration

0.2 µm pore-size

69.1

73.5

Table 3: Procedural Control for the Filtration Procedure (preliminary test)

Procedural control

Meas. Conc. [mg/L]

Mean

RR [%]

from calibration

10.24872

10.22

-

10.19639

filtrated

10.1841

-

99.6

Table 4: Recovery rates of the fortified samples (HPLC analysis):

Replicate No

1 x LOQ

10 x LOQ

Calc. conc. [mg/L]

RR [%]

Calc. conc. [mg/L]

RR [%]

1

5.07

101

49.3

99

2

5.07

101

49.7

99

3

5.08

102

50.2

100

4

5.11

102

50.3

101

5

5.09

102

49.9

100

Mean

5.08

102

49.9

100

SD

0.02

0.4

CV [%]

0.37

0.85

Calc. conc. = Calculated concentration, exact weight and dilution factor of 10 taken into account

RR = Recovery rate, related to the fortified concentration

SD = Standard deviation

CV = Coefficient of variation

Conclusions:
In the present study conducted according to OECD guideline 105 (1995) the water solubility of m-Xylylenebismaleimide was determined by the flask method. The water solubility of the test item is 37.6 mg/L at 20°C and a pH of 5.3.

Description of key information

-study according to OECD guideline 105, GLP, water solubility of m-Xylylenebismaleimide is 37.6 mg/L at 20°C and a pH of 5.3.

Key value for chemical safety assessment

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

Additional information

In the present study conducted according to OECD guideline 105 (1995) the water solubility of m-Xylylenebismaleimide was determined by the flask method. A preliminary test was performed in order to verify the planned study design. For this purpose 50 mg of the test item were mixed with 50 mL double distilled water in duplicate and stirred for 2 weeks. after this incubation aliquots of each mixture were centrifuged at 20 °C and 10000 x g for 10 min as well as at 20000 x g for 20 min and filtrated via syringe filters with a pore-size of 0.2 um, respectively. For each sample, 0.5 mL of the aqueous phase was transferred into a clear glass vial and checked for Tyndall-effects. For each sample, and thus for each used phase separation procedure, a Tyndall effect was observed. The least visible Tyndall effect was observed for the filtrated samples. The solubility was determined to be in the range of 70 mg/L for the filtrated samples, no significant loss of the test item was observed for the procedural control. For the definitive testing, filtration was used for the phase separation and slight Tyndall effects are deemed to be acceptable.

In the definitive test HPLC analysis after a preincubation time of 48 and 72 h revealed a water solubility of 37.6 mg/L at 20°C and a pH of 5.3.