Registration Dossier

Diss Factsheets

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
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:
From 02 February 1994 to 11 February 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose for cross-reference:
other: Reference to the validated analytical method used for quantification of the water samples.
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes
Type of method:
column elution method
Key result
Water solubility:
< 9 µg/L
Temp.:
20 °C
pH:
6
Remarks on result:
other: The concentration in the water samples obtained from two test columns and the blank column was below the limit of detection.
Conclusions:
The water solubility of the substance at 20°C was determined to be < 9 µg/L.
Executive summary:

The water solubility of the substance was determined using the column elution method in a GLP study according to EC A.6. Quantification was performed by HPLC-UV. The substance concentration was below the limit of detection. The water solubility at 20°C was therefore determined to be < 9 µg/L. The pH of the aqueous samples was 6.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion