Guanidine, N-phenyl-, compd. with carbonic acid, hydrate (2:1:2)

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November - December 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: US Federal Register 40 CFR 796.1840 (1985)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

This study has been performed in compliance with Good Laboratory Practice (GLP) in Switzerland, Procedures and Principles, March 1986, issued by the Federal Department of the Interior and the Intercantonal Office for the Control of Medicaments, Switzerlan

Type of method:

flask method

Key result

Water solubility:

ca. 7 500 mg/L

Conc. based on:

test mat.

Temp.:

25 °C

pH:

10.4

Centrifugation at 30,000 G, different equilibration times

Sample number	1	4	7
Weight of the test substance [g] dispersed in 50.0 ml of water	0.9922	1.0752	0.9978
Number of days at 30.0 °C	3	2	1
Number of days at 25.0 °C	1	1	1
Centrifugation: [G]	30,000	30,000	30,000
Centrifugation time: [min]	40	40	40
pH of aqueous solution	10.36	10.38	10.38
Water solubility [g/l] 1^st determination 2^nd determination average	7523.295 7506.567 7514.931	7617.113 7628.294 7622.704	7508.848 7512.366 7510.607
Total average	7549
Rel. standard deviation	0.76%

Centrifugation at 40,000 G, different equilibration times

Sample number	2	5	8
Weight of the test substance [g] dispersed in 50.0 ml of water	1.0586	1.1734	1.0326
Number of days at 30.0 °C	3	2	1
Number of days at 25.0 °C	1	1	1
Centrifugation: [G]	40,000	40,000	40,000
Centrifugation time: [min]	40	40	40
pH of aqueous solution	10.38	10.38	10.38
Water solubility [g/l] 1^st determination 2^nd determination average	7551.238 7552.569 7551.904	7512.497 7522.688 7517.593	7636.058 7645.184 7640.621
Total average	7570
Rel. standard deviation	0.75%

Centrifugation at 50,000 G, different equilibration times

Sample number	3	6	9
Weight of the test substance [g] dispersed in 50.0 ml of water	1.0058	1.0015	1.0057
Number of days at 30.0 °C	3	2	1
Number of days at 25.0 °C	1	1	1
Centrifugation: [G]	50,000	50,000	50,000
Centrifugation time: [min]	40	40	40
pH of aqueous solution	10.43	10.37	10.38
Water solubility [g/l] 1^st determination 2^nd determination average	7481.408 7458.649 7470.029	7390.941 7379.254 7385.098	7450.122 7459.670 7454.896
Total average	7437
Rel. standard deviation	0.56%

Conclusions:

Interpretation of results (migrated information): soluble (1000-10000 mg/L)
The solubility of the pure substance in water was determined to be 7500 mg/L at pH 10.4 and 25°C.

Executive summary:

The study was carried out under GLP rules.

The study was performed in accordance with the EC Guideline EG-Richtlinie A.6, Amtsblatt der Europäischen Gemeinschaften 84/449, Nr. L 251/44 - 52, (1984); the OECD guideline No. 105 for the testing of chemicals, (1981); as well as with the US Federal REgister 40 CFR part 796.1840 (1985).

The solubility, corrected to two significant figures, of the pure substance in water was determined to be 7500 mg/L at pH 10.4 and 25°C.

Description of key information

The study was carried out under GLP rules.
The study was performed in accordance with the EC Guideline EG-Richtlinie A.6,

Amtsblatt der Europäischen Gemeinschaften 84/449, Nr. L 251/44 - 52, (1984); the OECD guideline No. 105 for the testing of chemicals, (1981); as well as with the US Federal Register 40 CFR part 796.1840 (1985).
The solubility, correct to two significant figures, of the pure substance in water was determined to be 7500 mg/L at pH 10.4 and 25°C.

Key value for chemical safety assessment

Water solubility:

7 500 mg/L

at the temperature of:

25 °C