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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
other: Currenta internal SOP 00190 Version 3
Version / remarks:
This SOP is based on the Council Regulations EC No 440/2008, Guideline Part A – Methods for the Determination of the physical-chemical properties, A.6, “Water solubility” and to the OECD guideline for testing of chemicals No: 105 “Water solubility“.
Deviations:
no
Qualifier:
according to
Guideline:
other: Currenta internal SOP 00178 Version 3 for the determination of the pH-value
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
column elution method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Water solubility
Key result
Water solubility:
0.071 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
>= 6.3 - <= 7.5
Remarks on result:
other: mean value of both columns

Applicant's summary and conclusion

Conclusions:
The GLP study was performed according to OPPTS 830.7840 without deviations and therefore reliability of Klimisch 1 has been assigned. The water solubility has been determined to be 0.071 mg/L (insoluble) at 20 °C and pH 6.3 - 7.5.
Executive summary:

The water solubility of the test item pyridon was determined with the column elution method at 20 °C according to OPPTS 830.7840. The concentration of the test item in the aqueous test solutions was determined by HPLC analysis. The water solubility of the test item is stated as: 0.071 mg/L. Difference between both columns: 17 %; the validity criterion (mean of both determinations should not differ by more than 30 %) was met. The substance is insoluble in water.