Tris(2-ethylhexyl) phosphate

Surface tension

Administrative data

Endpoint:

surface tension

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because based on structure, surface activity is not expected or cannot be predicted

the study does not need to be conducted because surface activity is not a desired property of the material

the study does not need to be conducted because water solubility is below 1 mg/L at 20°C

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
In accordance with REACH Annex VII 7.6., column 2, the study needs ONLY be conducted if surface activity is expected or can be predicted based on structure, or if surface activity is a desired property. If the water solubility is below 1 mg/L at 20°C the study does not need to be conducted.
Surface activity is not predicted based on the structure of the substance and is not a desired property. Additionally, the water solubility is <1 mg/L at 20°C. The substance fulfils the 3 exemption criteria, while one is sufficient to waive the study.

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 August 2016 to 14 September 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The study was conducted in accordance wiith international guidelines and in accordance with GLP. All relevant validity criteria were met, with the caveat of the guideline deviation noted in Materials and Methods.

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Version / remarks:

27 July 1995

Deviations:

yes

Remarks:

In accordance with Paragraph 23, the difference between the last two measurements was >15 %. As there was no increasing tendency in the 3 measurements, the water solubility was determined as an average of flasks 1-3.

GLP compliance:

yes (incl. QA statement)

Type of method:

flask method

Key result

Water solubility:

0.14 µg/L

Temp.:

20 °C

pH:

ca. 6

Remarks on result:

other: average of flasks 1-2-3

Water solubility:

0.12 µg/L

Conc. based on:

test mat.

Loading of aqueous phase:

100 mg/L

Incubation duration:

24 h

Temp.:

20 °C

pH:

6.1

Remarks on result:

other: flask 3

Water solubility:

0.17 µg/L

Conc. based on:

test mat.

Loading of aqueous phase:

100 mg/L

Incubation duration:

48 h

Temp.:

20 °C

pH:

6

Remarks on result:

other: flask 2

Water solubility:

0.13 mg/L

Conc. based on:

test mat.

Loading of aqueous phase:

100 mg/L

Incubation duration:

72 h

Temp.:

20 °C

pH:

6

Remarks on result:

other: flask 1

Details on results:

In accordance with Paragraph 23, the difference between the last two measurements was >15 %. As there was no increasing tendency in the 3 measurements, the water solubility was determined as an average of flasks 1-3.

Table 1. Water Solubility Results

Test at 20 °C	Flask 1 (72 h)	Flask 2 (48 h)	Flask 3 (24 h)	Mean Value Flasks 1 to 3
Water Solubility of Test Item	0.13 μg/L	0.17 μg/L	0.12 μg/L	0.14 μg/L
pH	6.0	6.0	6.1	-

Conclusions:

The water solubility of the test item was determined to be 0.14 μg/L at 20°C and pH ca 6.

Executive summary:

The water solubility of the test item was determined in accordance with Council Regulations EC No 440/2008, Guideline Part A – Methods for the Determination of the physical-chemical properties, A.6, “Water solubility” (adopted, May 2008) and to the OECD guideline for testing of chemicals No: 105 “Water solubility“ (adopted 27th July 1995).

The flask method was used with a loading rate of 100 mg/L. Three flasks were incubated at 20°C, with sampling occurring at 24, 48 and 72h. Phase separation was carried out by centrifugation (20 minutes, 10000 rpm, 20 °C). Following phase separation, the pH was determined followed by HPLC/MS analysis to determine the dissolved concentration of test item.

The water solubility of the test item was determined to be 0.14 μg/L at 20°C and pH ca 6.