Registration Dossier

Administrative data

Endpoint:
hydrolysis
Data waiving:
study technically not feasible
Justification for data waiving:
the study does not need to be conducted because the substance is highly insoluble in water
other:
Cross-reference
Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From October 27, 2016 to July 03, 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose:
reference to same study
Qualifier:
according to
Guideline:
other: OECD 115
Deviations:
no
Qualifier:
according to
Guideline:
other: UNE 55-50
Deviations:
no
GLP compliance:
not specified
Type of method:
other: Tensiometer Kruss Standard plate method
Key result
Water solubility:
4.8 mg/L
Conc. based on:
test mat.
Temp.:
25 °C
Remarks on result:
other: Critical micelle concentration

Results: The intercept of the regression lines at stable surface tension and the line representing the lineal decrease of Surface tension is considered to represent the Critical Micelle Concentration (CMC).

The Critical Micelle Concentration is therefore estimated as 4.8 mg/l (refere attached background material for CMC graph).

C (ppm) ST mN/m log C
1.16 39.1 0.065
2.21 34.3 0.344
5.1 31.3 0.708
10.37 31.7 1.016
15.5 32.4 1.19
20.48 32.3 1.311
40.99 32.9 1.613
Conclusions:
Under the study conditions, the the CMC or water solubility of the test substance was determined to be 4.8 mg/L at 25°C.
Executive summary:

A study was conducted to determined the water solubility of the test substance, Quaternary ammonium compounds, N,N,N'-tris(hydroxyethyl)-N,N'-dimethyl-N'-tallow alkyltrimethylenedi-, bis(Me sulfates) (salts), based on critical micelle concentration (CMC), according to the OECD Guideline 115 and EU Method A.5. Due to the surface activity of the test substance, the CMC value was considered as a water soluibility equivalent in accordance with the ECHA R.7a Guidance. Under study conditions, the CMC of the test substance was determined to be 4.8 mg/L at 25˚C (Carrillo, 2017).

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion