Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
adsorption / desorption: screening
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance has a low octanol water partition coefficient and the adsorption potential of this substance is related to this parameter
the study does not need to be conducted because the physicochemical properties of the substance indicate that it can be expected to have a low potential for adsorption
Justification for type of information:
The substance is functionally water soluble.
The Log Kow < 0 and adsorption to soils and sediments is not conisdered to be significant.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
The precise temperature was not recorded (methods followed are at 'ambient' temperature)
The pH was not reported (performed at 'natural' pH, ca pH 10)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
GLP compliance:
yes (incl. QA statement)
Type of method:
HPLC method
Partition coefficient type:
octanol-water
Specific details on test material used for the study:
Not specifed if material was 'water-free' (dried) material, but the presence of water would not make a difference with this method.
Analytical method:
high-performance liquid chromatography
Type:
log Pow
Partition coefficient:
< 0
Temp.:
20 °C
pH:
ca. 10
Remarks on result:
other: Precise figure not possible to determine
Details on results:
The test material eluted close to the solvent front and appeared not to be retained in the column, suggesting a Log Kow < 0
Only a single peak was observed using Refractive Index detector and Diode Array Detector.
The precise temperature was not recorded (methods followed are at 'ambient' temperature)
The pH was not adjusted.
Conclusions:
The very high water solubility would suggest that the partition coefficient is unlikely to be > 1 and despite some methodological deficiencies, the result is conclusive.
Only a single HPLC peak was reported, but in view of the type of column and mobile phase, the different speicies of the UVCB would not appear separate under the conditions of the test; this does however demonstrate that there are no minor components with a significant partition coefficient.
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Solublity limits based on manufacturing - the substance is manufactured and supplied in water
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method A.6 (Water Solubility)
GLP compliance:
no
Type of method:
other: Direct observations
Specific details on test material used for the study:
Manufactured in water to give a solution > 40% actives
Water-free samples have been prepared
Water solubility:
> 570 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
570 g/L
Temp.:
20 °C
pH:
ca. 10.8

Substance is manufactured and supplied in water.

Conclusions:
Loss on removal of water was 43%, suggesting ca 43% w/w water (ie ca 57% solution in water as manufactured)
The measured pH is 10.8

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion