2-((E)-(4-((4-(1,3-dioxo-1,3-dihydro-2H-hetereocarbapolycyclo-2-yl)alkyl)(ethyl)amino)-2-methyl)diazenyl)-5-nitro-1,3-dicarbonitrile, polyphenyl

Water solubility

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

no

Test guideline 2

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.