Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
01.02.2018 - 30.07.2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: CIPAC MT 181
GLP compliance:
no
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Water solubility
Key result
Water solubility:
< 10 mg/L
Conc. based on:
test mat.
Loading of aqueous phase:
10 g/L
Incubation duration:
10 min
Temp.:
20 °C
pH:
ca. 7.8

Applicant's summary and conclusion

Conclusions:
The solubility of the test item, AGENT 5088-127A was found to be ˂ 10 g/L at 20 ± 1°C, as determined in accordance with CIPAC Method MT 181.
Executive summary:

Preliminary Test - As per CIPAC Method MT 181

The preliminary test was performed as perCIPAC MT 181 (CIPAC,1998),to determine the approximate solubility of the test item and based on the results of the preliminary test, the approximate weight of the test item was selected for the definitive test was decided.

About 0.1 g of test item was weighed in triplicate in to separate 10 mL glass stoppered measuring cylinders. Then, 0.5 mL of double distilled water was added to each measuring cylinders followed by incremental addition of
0.5 mL, 0.5 mL,1.0 mL and up to 10.0mL. After addition of each aliquot of double distilled water, the cylinders were stoppered, shaken vigorously and stored in an incubator maintained at 20 ± 1°C (maximum and minimum temperatures were 20.2°C and 19.8°C, respectively) for 10 min with intermittent shaking. After 10 min of storage at 20 ± 1°C, the measuring cylinders were taken out and the contents of the cylinders were visually checked for presence of any un-dissolved test item before making the next addition of solvent.

The approximate solubility of test item in double distilled water was recorded as given below:

Solvent

Repli-cation

Weight of test item (g)

Total Volume of Double Distilled Water added

(mL)

Approximate Solubility

At 20 ± 1°C

(g/L)

Double distilled water

R1

0.1006

10.0

<10

R2

0.1002

R3

0.1001

After addition of 10 mL of double distilled water,the test item remained insoluble in 10 mL of double distilled water andthe solubility was recorded as <10 g/L and the definitive test was not carried out.