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Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-09-23 till 2008-10-08
Reliability:
1 (reliable without restriction)
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
column elution method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of the test material (as cited in the study report: FAT 40842/A TE
- Substance type: coloring dye
- Physical state: solid, dark bluish green powder
- Analytical purity: 96%
- Lot/batch No.: Blau DRI 2098 Op 1/07
- Expiration date of the lot/batch: June 30, 2014
- Storage condition of test material: at room temperature at about 20 ºC

Results and discussion

Water solubility
Water solubility:
< 0.05 mg/L
Temp.:
20 °C
pH:
>= 5.31 - <= 6.9

Any other information on results incl. tables

Results of the Water Solubility of FAT 40842/A TE

 

Experiment

No

Flow rate[mL/h]

 

 

Sample No.

 

Concentration Analyzed[μg/mL]

Water solubility calculated [mg/L]

pH

1

31

1

<0.0523

<0.0523

SD = ± 0.00

SD rel.=0.00%

<0.05

6.79

2

<0.0523

6.74

3

<0.0523

5.31

4

<0.0523

6.77

5

<0.0523

5.84

6

<0.0523

6.82

2

16

7

<0.0522

<0.0522

SD = ± 0.00

SD rel. =0.00%

 

6.75

8

<0.0522

6.85

9

<0.0522

6.81

10

<0.0522

6.90

11

<0.0522

6.43

12

<0.0522

6.46

SD = Standard deviation

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): insoluble (< 0.1 mg/L)
FAT 40842/A TE is poorly soluble (<0.05mg/L)
Executive summary:

The determination of the water solubility of FAT 40842/A TE was performed according to the

EEC Directive 92/69, A.6 “Water Solubility” (1992) and the OECD guideline No. 105, “Water Solubility” (adopted July 27, 1995), using the column elution method.

 

During the preliminary test the water solubility of FAT 40842/A TE at room temperature was

estimated by a simplified flask method to be lower than the smallest calibration point of 0.5408μg/mL. Therefore, the column elution method was used for the performance of the main test.

 

During the main test six samples have been analyzed in the first run (0.53 mL/min) and six

samples during the second run (0.265 mL/min), each with a sampling interval of one hour. Total elution time was 93.67 hours. The sample measurement was performed by HPLC.

 

The water solubility of FAT 40842/A TE at 20 °C was determined to be <0.05 mg/L.

Remark: The water solubility was not corrected for the purity of the test item.

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