Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 February 2015 - 28 May 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study is considered to be a reliability 1 as it has been conducted according to EC A.6 and OECD TG 105 using the flask method and in compliance with 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)
Version / remarks:
(1995)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
(2008)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Version / remarks:
(1998)
Deviations:
no
GLP compliance:
yes
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material in report: IFF 09-0035
- Physical state: Clear liquid
- Storage condition of test material: At room temperature protected from light

Results and discussion

Water solubility
Water solubility:
64 mg/L
Temp.:
20 °C
pH:
6.6 - 6.8
Remarks on result:
other: Mean of 6 measurements, for 24 to 168 hour stirred samples.
Details on results:
Preliminary test:
The preliminary estimate of water solublity was 0.123 g/L.

Definitive test #1:
The maximum difference (MD) calculated from the concentrations in the 24, 48 and 72 hour test samples was > 15% (38%) and concentration increased with stirring time (from 0.0526 to 0.0771 g/L)

Definitive test #2:
The maximum difference (MD) calculated from the concentrations in the 120, 144 and 168 hour test samples was > 15% (19%). Concentrations had not further increased and were in the same range as the results of definitive test #1 (from 0.0591 to 0.0713 g/L)

Water solubility of the substance:
Since the results were all in the same range and since further improvement of the method to obtain a more accurate water solubility for this volatile substance is not possible, it was decided to calculate the water solubility of the test substance as the mean value of all 6 measurements.

Any other information on results incl. tables

The concentration (g/L) of test material in the sample solutions is shown in the table below.

 

Definitive test

Stirring time

[hours]

Analysed concentration

[g/L]

Mean concentration

[g/L]

Maximum difference (MD)

[%]

pH

#1

24

0.0526

0.064

38%

6.8

48

0.0610

6.8

72

0.0771

6.8

#2

120

0.0626

6.6

144

0.0591

6.6

168

0.0713

6.6

No test substance was detected in the pretreated sample from the blank water mixtures.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
The water solubility of IFF 09-0035 was determined to be 64 mg/L @ 20°C using EC A.6 and OECD TG 105 (Water solubility) using the flask method in compliance with GLP.
Executive summary:

The water solubility of IFF 09-0035 was determined to be 64 mg/L @ 20 °C using OECD TG 105 and EC A.6 and according to GLP, using the flask method. The samples were slowly stirred and headspace was kept minimal.