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: Guideline study, to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Principles of method if other than guideline:
A modified shake flask method was adopted, slowly stirring at 20 °C in the sark, sampling daily until equilibrium was achieved.
GLP compliance:
yes (incl. certificate)
Type of method:
other: a modified shake flask method was adopted

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
impurity
Test material form:
other: liquid, may crystalize to white solid
Specific details on test material used for the study:
Details on Test Material
- Name of test material (as cited in study report): Pivacyclene
- Physical state: Colourless to pale yellow liquid, may crystalize.
- Analytical purity: >=92.0 %
- Lot/batch No.: SC00004118
- Expiration date of the lot/batch: 17 July 2014.
- Stability under test conditions: Stable.
- Storage condition of test material: Protect from light. Refrigerated at 2 to 8 °C

Results and discussion

Water solubility
Water solubility:
3.53 mg/L
Temp.:
20 °C
pH:
7

Applicant's summary and conclusion

Conclusions:
The solubility of Pivacyclene in water at 20 °C is 3.53 mg/L
Executive summary:

In an OECD guideline study (TG 105), conducted to GLP, the solubility of Pivacyclene in water (at 20 °C and using a modified shake flask method) was determined to be 3.53 mg/L.