Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to the recommended guidelines and GLP. There were minor deviations from the protocol which did not adversely affect the study integrity.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
yes
Remarks:
Minor deviations which did not adversely affect the study integrity.
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
yes
Remarks:
Minor deviations which did not adversely affect the study integrity.
GLP compliance:
yes (incl. certificate)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Water solubility
Water solubility:
>= 4.3 - <= 11 mg/L
Temp.:
19.8 °C
pH:
6.3

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
The water solubility of the test substance at 19.8°C±0.6°C was estimated to be between 4.3 – 11 mg/l. The pH of the aqueous samples after 76.5 hours of stirring was 6.3.

There were minor deviations from the protocol which did not adversely affect the study integrity; validity criteria have been fulfilled.