Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2020
Report Date:
2020

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 830.7570 (Partition Coefficient, n-octanol / H2O, Estimation by Liquid Chromatography)
GLP compliance:
yes
Remarks:
GLP compliance statement is included in attached full study report.
Type of method:
HPLC method
Partition coefficient type:
octanol-water

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
Batch #: 191016
Expiration Date: October 15, 2020
0.9% (9306 mg/L) mineral complexed organic matter (based on total organic carbon content of 0.51%)
1124 mg/L Fe
3333 mg/L Na
2187 mg/L total inorganic carbon
pH=7.28
Density: 1.011 g/mL at 25 degrees C

Study design

Analytical method:
high-performance liquid chromatography

Results and discussion

Partition coefficient
Type:
log Pow
Remarks on result:
not determinable
Remarks:
The test substance, FBS Transit, eluted earlier than thiourea, which was used to measure dead time. FBS Transit was determined to be too polar and not applicable for partition coefficient analysis.
Details on results:
See Tables 3 and 4 below.

Any other information on results incl. tables

Table 3: Reference Substances Calibration





































































CompoundMR TimeCapacity kLog kLow PowCalc. Log Pow
Thiourea1.540.00NANANA
Acetanilide1.810.18-0.751.000.95
Toluene3.331.160.072.703.18
Diphenylamine3.361.180.073.403.20
Phenyl Benzoate3.731.430.153.603.43
Naphthalene4.011.610.213.603.57
Phenanthrene7.273.730.574.604.57

NA- not applicable, MR- mean retention


Calibration Curve Statistics:


Slope = 2.74


y-intercept = 3.00


Correlation Coefficient = 0.98


Table 4: Test Substance Results













































FBS TransitRetention Timek
Run 11.273-0.17
Run 21.290-0.16
Run 31.293-0.16
 Average k = -0.1641
 Log k = NA
 Low Pow = NA
 Pow = NA

NA- not applicable

Applicant's summary and conclusion

Conclusions:
FBS Transit was determined to be too polar and not applicable for partition coefficient analysis.