Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05 Aug 2019 - 26 Sep 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The water solubility of this surface active substance was studied as it proved technically not possible to determine the critical micelle concentration (CMC).
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2020
Report date:
2020

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
2016
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
1995
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Version / remarks:
1998
Deviations:
no
GLP compliance:
yes
Type of method:
flask method

Test material

Constituent 1
Chemical structure
Reference substance name:
Salts of phosphoric acid, 2-ethylhexyl esters with C16-18 (even numbered) and C18-unsaturated-alkylamines
EC Number:
949-859-1
Molecular formula:
not applicable
IUPAC Name:
Salts of phosphoric acid, 2-ethylhexyl esters with C16-18 (even numbered) and C18-unsaturated-alkylamines
Test material form:
liquid
Details on test material:
- Appearance: Clear yellow liquid
- Storage condition: At room temperature

Results and discussion

Water solubilityopen allclose all
Key result
Water solubility:
0.749 g/L
Conc. based on:
other: based on the mono-ester
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
>= 3.2 - <= 3.2
Remarks on result:
other: at a loading rate of 1 g/L
Key result
Water solubility:
0.003 g/L
Conc. based on:
other: based on the di-ester
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
>= 3.2 - <= 3.2
Remarks on result:
other: at a loading rate of 1 g/L
Key result
Water solubility:
3.4 g/L
Conc. based on:
other: based on the mono-ester
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
>= 2.5 - <= 2.5
Remarks on result:
other: at a loading rate of 10 g/L
Key result
Water solubility:
0.003 g/L
Conc. based on:
other: based on the di-ester
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
>= 2.5 - <= 2.5
Remarks on result:
other: at a loading rate of 10 g/L
Details on results:
- For the mono-ester, maximum differences (24, 48 and 72 h) meet the criterion of ≤ 15% (i.e. 14% and 3.2%)
- For the di-ester, maximum differences (24, 48 and 72 h) do not meet the criterion of ≤ 15% (i.e. 33% and 21%), which is due to the low concentration level measured (< 10 mg/L) and therefore accepted.
- No test item was detected in the pretreated sample from the blank

Any other information on results incl. tables

Table: water solubility results (flask method), based on the mono-ester

Loading rate

Stirring time
[hours]

Analyzed Test Item concentration [g/L]

Mean

[g/L]

Maximum difference

[%]

pH

 

 

 

 

 

 

Low

24

0.681

0.749

14

3.2

[1 g/L]

 

 

 

 

 

 

48

0.781

 

 

3.2

 

 

 

 

 

 

 

72

0.786

 

 

3.2

 

 

 

 

 

 

 

 

 

 

 

 

High

24

3.35

3.40

3.2

2.5

[10 g/L]

 

 

 

 

 

 

48

3.38

 

 

2.5

 

 

 

 

 

 

 

72

3.46

 

 

2.5

 

 

 

 

 

 

Table: water solubility results (flask method), based on the di-ester

Loading rate

Stirring time
[hours]

Analyzed Test Item concentration [g/L]

Mean
[g/L]

Maximum difference

[%]

pH

 

 

 

 

 

 

Low

24

0.00271

0.00331

33

3.2

[1 g/L]

 

 

 

 

 

 

48

0.00345

 

 

3.2

 

 

 

 

 

 

 

72

0.00378

 

 

3.2

 

 

 

 

 

 

 

 

 

 

 

 

High

24

0.00291

0.00283

21

2.5

[10 g/L]

 

 

 

 

 

 

48

0.00250

 

 

2.5

 

 

 

 

 

 

 

72

0.00308

 

 

2.5

 

 

 

 

 

 

Applicant's summary and conclusion

Conclusions:
The water solubility of the substance at 20°C, at low and high loading rate, was determined to be 0.749 and 3.40 g/L based on the mono-ester and 0.00331 and 0.00283 g/L based on the di-ester.
Executive summary:

The water solubility of the substance was determined using the slow-stirring-flask method based on EC A.6, OECD 105 and OPPTS 830.7840. The study was performed directly at the test temperature of 20°C. Since the test item is an UVCB substance, the main study was performed at loading rates of 1 g/L (low loading rate) and of 10 g/L (high loading rate).

Quantification was performed by UPLC-MS/MS. The pH of the aqueous samples was 3.2 and 2.5, at the low and high loading rate, respectively.

The water solubility of the substance at 20°C, at low and high loading rate, was determined to be 0.749 and 3.40 g/L based on the mono-ester and 0.00331 and 0.00283 g/L based on the di-ester.

Categories Display