Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
other: visual observation and titration analysis
Adequacy of study:
key study
Study period:
August 2017
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
The substance can be produced through different process routes, yielding solutions in water or organic solvent (e.g. methanol or ethylene glycol).
It was initially unclear how to register the substance (mono-constituent or multi-constituent substance) and which manufactured substance to test to fulfil the REACH data requirements. After consultation with the ECHA helpdesk, the test program was started with the manufactured substance of the Lead registrant (solvent: methanol) in which the highest amount of solvent could be removed without causing degradation of the substance. This resulted in the selection of a solution of 56-57% BTMAOH in methanol as test substance.
During the course of the test program, and in order to aid meaningful risk assessment, after consultation with ECHA and upon ECHA's recommendation, it was considered to be more appropriate to test the water-based manufactured substance. As a consequence, some testing was performed with a BTMAOH solution in methanol, and some testing was performed with a BTMAOH solution in water.

The current entry presents data obtained with a water-based test solution.

Data source

Referenceopen allclose all

Reference Type:
other company data
Title:
Unnamed
Year:
2017
Report Date:
2017
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A study was not conducted because other information is available: the test item is a 20% solution in water and described as ‘Clear, almost colourless liquid’. This indicates complete dissolution of the substance at 200 g/L and therefore a test was considered not necessary. In addition, the BTMAOH content and the water content of the test item were confirmed by titration analyses (see also section 1.4).
GLP compliance:
no
Type of method:
other: visual observation and titration analysis

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Appearance: Clear almost colourless liquid
Test item storage: At room temperature
Stable under storage conditions until: 30 November 2020 (expiry date)

Results and discussion

Water solubility
Key result
Water solubility:
> 200 g/L
Conc. based on:
test mat.
Temp.:
20 °C
Remarks on result:
not measured/tested
Remarks:
based on BTMAOH content (detemined by titration) in an aqueous solution with pre-defined target concentration
Details on results:
The test item is a solution of BTMAOH in water. As there was no visual observation of undissolved material in the solution, the substance is considered completely dissolved in water, and therefore the water solubility is estimated to be > 200 g/L.

Applicant's summary and conclusion

Conclusions:
The water solubility of the substance is > 200 g/L.