Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September-October 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
GLP compliance:
not specified
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Type:
impurity
Test material form:
liquid
Details on test material:
Common Name: BT4
Source Intertek Chemicals & Materials, Allentown
Purity: 85%
ID and percent known impurities: 2-ethylhexyl stearate (12%), 2-ethylhexyl palmitate (1%), 2-ethylhexyl esters of various C18 fatty acid impurities (~3%)
Date Received at Test Facility: September 5, 2019
Storage Instructions2 Ambient Temp
Specific details on test material used for the study:
Common Name: BT4
Source Intertek Chemicals & Materials, Allentown
Purity: 85%
ID and percent known impurities: 2-ethylhexyl stearate (12%), 2-ethylhexyl palmitate (1%), 2-ethylhexyl esters of various C18 fatty acid impurities (~3%)
Date Received at Test Facility: September 5, 2019
Storage Instructions2 Ambient Temp

Results and discussion

Water solubility
Key result
Remarks on result:
not determinable
Remarks:
Direct measurement of the water solubility by OECD Test Guideline 105 was not possible due to surfactant properties of the Test Item. The Test Item is not stable in water but forms micelle structures resulting in suspension. An exemption from OECD 105 is requested.
Details on results:
In the preliminary test, at 1 g/L the Test Item solution was clear, and had residual liquid on the surface. The definitive test was setup at the 1 g/L level.

The definitive test was started and a sample was taken at the 6 day mark. The Test Item had formed a cloudy suspension in water. It was stable after being left to sit at room temperature for 24 hours. The suspension was filtered through Whatman 40 filter paper. The filter removed some of the Test Item but the solution was still slightly cloudy. The solution exhibited surface foaming when shaken.

No chemical instability was observed during the test, however surfactant properties were observed and confirmed.

Applicant's summary and conclusion

Conclusions:
Direct measurement of the water solubility by OECD Test Guideline 105 was not possible due to surfactant properties of the Test Item. The Test Item is not stable in water but forms micelle structures resulting in suspension. An exemption from OECD 105 is requested.
Executive summary:

The solubility of BT4 was tested according to OECD Guideline for the Testing of Chemicals. Test No. 105: Water Solubility, using the flask method.

A preliminary test was conducted in order to approximate the amount of Test Item that would dissolve in water and the time required to reach saturation.

At 1 g/L the Test Item solution was clear, and had residual liquid on the surface. The definitive test was setup at the 1 g/L level.

The definitive test was started and a sample was taken at the 6 day mark. The Test Item had formed a cloudy suspension in water. It was stable after being left to sit at room temperature for 24 hours. The suspension was filtered through Whatman 40 filter paper. The filter removed some of the Test Item but the solution was still slightly cloudy. The solution exhibited surface foaming when shaken.

No chemical instability was observed during the test, however surfactant properties were observed and confirmed.

The Test Item exhibits surfactant qualities (foaming, stable cloudy solution, cloudiness passes through a filter).
Direct measurement of the water solubility by OECD Test Guideline 105 was not possible due to surfactant properties of the Test Item. The Test Item is not stable in water but forms micelle structures resulting in suspension. An exemption from OECD 105 is requested.