Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Deviations:
no
GLP compliance:
yes
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Results and discussion

Water solubilityopen allclose all
Water solubility:
>= 0.263 - <= 0.322 g/L
Conc. based on:
test mat. (dissolved fraction)
Loading of aqueous phase:
0.3 g/L
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
>= 3.8 - <= 4
Water solubility:
>= 1.45 - <= 1.6 g/L
Conc. based on:
test mat. (dissolved fraction)
Loading of aqueous phase:
3 g/L
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
2.9
Details on results:
Low nominal level:
The 24-hour measurement was significantly lower than the 48- and 72- hour measurements (maximum difference > 15%). Based on this, the water solubility of the water extractable constituents of the test item was given as the mean value of the 48- and 72-hour measurements. No test item was detected in the pretreated sample from the blank water mixture.

High nominal level:
The maximum difference of the concentrations determined in the 24, 48 and 72 hour test samples was ≤ 15%. Based on this, the water solubility of the water extractable constituents of the test item is given as the mean value of the analyzed concentrations. No test item was detected in the pretreated sample from the blank water mixture.

Any other information on results incl. tables

Low nominal level (loading rate 1; 0.3 g/L)

 Stirring time

(Hours)

 Analysed concentration (g/L)  Mean (g/L)  Maximum difference (%) pH 
 24  0.263  0.310  7.6  3.9
 48  0.299      3.8
 72  0.322      4.0

 

High nominal level (loading rate 2; 3 g/L)

Stirring time

(Hours)

 Analysed concentration (g/L)  Mean (g/L)  Maximum difference (%) pH 
 24  1.45  1.51  9.8  2.9
 48  1.60      2.9
 72  1.49      2.9

Applicant's summary and conclusion

Conclusions:
The water solubility value of the water extractable constituents of this complex UVCB (those that dissolved) at 20°C, was determined to be 0.310 to 1.51 g/L under the conditions of the test. In reality the procedure used removed many of the insoluble constituents and accordingly the aqueous solubility of the UVCB substance as a whole is likely to be much lower.