Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018-10-19 to 2018-10-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: CIPAC MT 157.1
Version / remarks:
CIPAC Handbook Volume F, “Physico chemical Methods for Technical and Formulated Pesticides”, W. Dobrat and A. Martijn (1995)
GLP compliance:
no
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Specific details on test material used for the study:
white, crystalline powder

Results and discussion

Water solubility
Key result
Water solubility:
< 10 mg/L
Conc. based on:
test mat.
Incubation duration:
> 10 - < 15 min
Temp.:
23.6 °C
Remarks on result:
other: for this preliminary test pH was not measured
Remarks:
graduated cylinder
Details on results:
The water solubility of the test item was determined at approx. 23.6 °C to be < 10 mg/L.
For details, please see section “any other information on results incl. tables”.

Any other information on results incl. tables

Test Temperature

Table 1: Temperature Data

Test

Temperature [°C]

Min.

Max.

Mean

Graduated
cylinder

22.1

23.6

22.851

Bottles

*

*

23.26

*The weather logger stopped by technical difficulties after 15 min.

Test with Graduated Cylinders

Table 2: Results of the Preliminary Test for Water ( 10 mg at max. 100 mL)

Test item (nominal 10 mg)
[mg]

Volume of

water, type I,

mL

Test item concentration
(nominal)
[g/L]

Homogenous solution
(visual)
[yes/no]

11

  1

11 (11000) 

no

  5

2.2 (2200)

no

10

1 (1000)

no

20

0.55 (550)

no

50

0.22 (220)

no

80 

100

0.1375 (137.5)

0.11 (110)

no

no

Table 3: Results of the Preliminary Test with Bottles (24 h-stirring, 100 rpm)

Test item (nominal 10 mg)
[mg]

Volume of

water, type I,

mL

Test item concentration
(nominal)
[mg/L]

Homogenous solution
(visual)
[yes/no]

10.3

  100

103  

no

10.0

  250

40

no

10.7

  500

21.4

no

10.9

1000

10.9

 no1

1) Still no homogenous solution after additional stirring for 21 h at room temperature; not even a significant amount of the used test item was observed to be dissolved

 

 

 

Applicant's summary and conclusion

Conclusions:
The water solubility of the test item at approx. 23.6 °C was < 10 mg/L.
Executive summary:

The water solubility of Ceramide VI was determined via shaking method followed by visual check according to CIPAC MT 157.1 (CIPAC Handbook Volume F, “Physico chemical Methods for Technical and Formulated Pesticides”, W. Dobrat and A. Martijn (1995)).

No dissolution was observed at any time point of the study.

The water solubility of Ceramide VI was determined to be < 10 mg/L at 23.6 °C.