Reaction product of {Sulfonic acid derivatives of [4-(aminoalkylamino)-6-substituted-1,3,5-triazin-2-ylamino]benzene}, ammonia water, sodium chloride and [poly(1~4)chlorosulfonyl(poly(1~4) benzo-poly(3~0)pyrido-5,10,15,20-tetraazaporphyrinato- N21,N22,N23,N24)]copper(II)

Water solubility

Administrative data

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Phys chem testing was conducted between 10 March 2011 and 12 April 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study performed under GLP. The standard A.6 Method was not applicable to this test item due to the high indeterminable saturation levels produced. It was therefore not possible to prepare samples at five times the saturation level as recommended in the guideline. No analysis could be performed due to the high solubility producing unfilterable mixtures and thus the water solubility was estimated based on visual inspection.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

yes

Remarks:

The test item produced high indeterminable saturation levels. Analysis could not be performed due to high solubility producing unfilterable mixtures and thus the water solubility was estimated based on visual inspection.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Deviations:

yes

Remarks:

The test item produced high indeterminable saturation levels. Analysis could not be performed due to high solubility producing unfilterable mixtures and thus the water solubility was estimated based on visual inspection.

GLP compliance:

yes (incl. QA statement)

Type of method:

other: visual inspection

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Identification: TM10-099
Description: dark blue powder
Batch number: MB-1
Date received: 4 March 2011
Expiry date: 4 March 2012
Storage conditions: room temperature in the dark

Results and discussion

Water solubility

Water solubility:

17 - 19.1 other: % w/w

Temp.:

20 °C

pH:

7.3 - 7.6

Details on results:

It is evident from the information obtained in the hydrolysis test and data relating to the pH of the test item in water that negligible hydrolysis of the sample solution occurred during the course of the water solubility test.
The standard A.6 Method was not applicable to this test item due to the high indeterminable saturation levels produced. It was therefore not possible to prepare samples at five times the saturation level as recommended in the guideline. No analysis could be performed due to the high solubility producing unfilterable mixtures and thus the water solubility was estimated based on visual inspection.

Any other information on results incl. tables

Preliminary test

Preliminary test result: In the range of 10.3 to 20.0% w/w.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): very soluble (> 10000 mg/L)
The water solubility of the test item has been determined to be in the range of 17.0 to 19.1 % w/w at 20.0 ± 0.5 °C.

Executive summary:

The water solubility of the test item TM10-099 was determined in a valid GLP study using a procedure based on the flask method designed to be compatible with OECD TG No105 and EU Method A.6.

The standard A.6 Method was not applicable to this test item due to the high indeterminable saturation levels produced. No analysis

could be performed due to the high solubility producing unfilterable mixtures and thus the water solubility was estimated based on visual inspection.

The water solubility of the test item has been determined to be in the range of 17.0 to 19.1 % w/w at 20.0 ± 0.5 °C.