disodium 7-(4,6-difluoropyrimidin-2-ylamino)-4-hydroxy-3-(4-methoxy-2-sulfonatophenylazo)naphthalene-2-sulfonate; reaction mass of: disodium 7-(2,4-difluoropyrimidin-6-ylamino)-4-hydroxy-3-(4-methoxy-2-sulfonatophenylazo)naphthalene-2-sulfonate

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Version / remarks:

adopted July 27, 1995

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Version / remarks:

EEC Publication No. L383, december 1992

GLP compliance:

yes

Type of method:

flask method

Key result

Water solubility:

13.4 g/L

Conc. based on:

test mat.

Incubation duration:

>= 24 - <= 72 h

Temp.:

20 °C

Remarks on result:

completely miscible

Details on results:

The test article consists of two isomers showing a different retention time. The total area of both peaks was used for quantification. The saturation concentration of SCARLET RN 1165 at room temperature was estimated by a simplified flask method in the preliminary test to be higher than 10-2 g/1.

The concentrations determined after 24 hours, 48 hours and 72 hours differ by less than 15 %. Therefore the study is considered to be valid.

In conclusion, the water solubility of SCARLET RN 1165 at 20 °C ± 1.0 °C was determined to be 13.4 g/1 (coefficient of variation= 4.68 %).

Data of the performance of the water solubility test

Sample solution no.	1	2	3	4	5	6
Weighed sample of the test article (g)	10.27	10.42	10.21	10.16	10.49	10.67
Added volume of water (ml)	25	25	25	25	25	25
Agitation time at 30°C (hours)	24	24	48	48	72	72
Equilibration time at 20°C (hours)	24	24	24	24	24	24
pH value of test article solution	5 -6	5 -6	5 -6	5 -6	5 -6	5 -6
Dilution factor before quantification	400	400	400	400	400	400

Results of the water solubility of SCARLET RN 1165

Sample no.	Shaking time at 30°C [hours]	Concentration of the test article found [mg/l]	Calculated saturation mass concentration [mg/l]
1	24	12778.8	13448.8                CV = 4.68%
2		13959.7
3	48	14415.7
4		13390.8
5	72	13238.3
6		12909.7

The saturation mass concentration is calculated from the bold values given in the column

"Concentration of the testarticle found".

CV = coefficient of variation

Conclusions:

The water solubility of SCARLET RN 1165 at 20 °C ± 1.0 °C was determined to be 13.4 g/l (coefficient of variation= 4.68 %).

Executive summary:

The determination of the water solubility of SCARLET RN 1165 was performed according to the EEC Directive 92/69, A.6 "Water Solubility" (1992) and the OECD guideline No. 105, "Water Solubility" (1995) using the flask shake method.

The test article consists of two isomers showing a different retention time. The total area of both peaks was used for quantification. The saturation concentration of SCARLET RN 1165 at room temperature was estimated by a simplified flask method in the preliminary test to be higher than 10-2 g/1.

The concentrations determined after 24 hours, 48 hours and 72 hours differ by less than 15 %. Therefore the study is considered to be valid.

In conclusion, the water solubility of SCARLET RN 1165 at 20 °C ± 1.0 °C was determined to be 13.4 g/1 (coefficient of variation= 4.68 %).

Description of key information

The water solubility of SCARLET RN 1165 at 20 °C ± 1.0 °C was determined to be 13.4 g/1 (coefficient of variation= 4.68 %) according to the EEC Directive 92/69, A.6 "water Solubility"• (1992) and the OECD guideline No. 105,

"water Solubility" (1995) using the flask shake method.

Key value for chemical safety assessment

Water solubility:

13.4 g/L

at the temperature of:

20 °C