Maltose

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 2017-07-03 to 2017-07-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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

Qualifier:

according to guideline

Guideline:

other: REACH Guidance Document "Guidance on information requirements and chemical safety assessment Chapter R.7a: Endpoint specific guidance” from Oct. 2015

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

flask method

Key result

Water solubility:

470.2 g/L

Conc. based on:

test mat.

Incubation duration:

3 d

Temp.:

20 °C

pH:

>= 4.42 - <= 6

Measurements during Equilibration

The data which was acquired during equilibration time (flask 1A-C, days 1 – 3) is presented in the following table:

Table 3a: Equilibration

Day	Tempera- ture [°C]	pH*	Area [mV*min] (diluted sample)	Measured concentration [mg/L]	Dilu- tion factor	Mean Concentration test item [g/L]**	Difference to previous sample in %
1	20.0	5-6	36.533	2607.1	200	477.8	-
			34.760	34.760
2	20.0	5-6	34.869	2501.7	200	471.8	-1.3
			35.409	35.409
3	20.0	5-6	38.228	2714.5	200	499.4	5.8
			36.710	36.710

* measured with pH-paper

** Recovery rate of the measured QC sample 106.8 % was taken into account

 

The plateau was considered as reached after 1 day shaking.

 

Measurements at Plateau

 

The following table gives the values, which were measured at the plateau.

 

Table 3b Plateau

Flask	Temperature	pH	Area [mV*min] (diluted sample)	Measured values analyte [mg/L]	Dilution factor	Mean Concentration test item [g/L]
Blank	20.0	7*	Not detectable	Not detectable	200	< LOQ
			Not detectable	Not detectable
2	20.3	4.56	31.778	2305.8	200	459.4
			31.490	2287.5
3	20.3	4.45	31.154	2266.2	200	445.5
			29.933	2188.9
4	20.3	4.45	32.855	2374.0	200	483.2
			34.178	2457.8
5	20.3	4.43	30.960	2253.9	200	454.7
			31.573	2292.8
6	20.3	4.42	32.704	2364.4	200	469.5
			32.171	2330.6

* measured with pH-paper

** measured with pH-meter

The measurements of the days 1, 2 and 3 were included in the calculation of the mean.

Table 3c: Measurements used for Calculation of Solubility

Day	Flask	Concentration	Total Mean	Total Standard Deviation [g/L]
		[g/L]	[g/L]	(RSD* [%])
1	1A	477.8	470.2	17.1 (3.6%)
2	1B	471.8
3	1C	499.4
3	2	459.4
3	3	445.5
3	4	483.2
3	5	454.7
3	6	469.5

* RSD = relative standard deviation

Conclusions:

The water solubility of the test item was determined to be 470.2 g/L ± 3.6 %. The result is also applicable for the water free form of the test item.

Executive summary:

A study was performed according to OECD TG 105 and Regulation (EC) No. 440/2008 method A.6 in order to determine the water solubility of the test item in water by using the flask method (analytical method: HPLC). The mean water solubility was determined to be 470.2 g/L ± 3.6 %. All replicates showed good correspondence. Equilibration was considered to be reached after 1 day. No observations arising doubts concerning the accuracy of the results and the validity of the study were made. The result is also applicable for the water free form of the test item.

Description of key information

The water solubility of the test item was determined to be 470.2 g/L ± 3.6 %. The result is also applicable for the water free form of the test item.

Key value for chemical safety assessment

Water solubility:

470.2 g/L

at the temperature of:

20 °C

Additional information

A study was performed according to OECD TG 105 and Regulation (EC) No. 440/2008 method A.6 in order to determine the water solubility of the test item in water by using the flask method (analytical method: HPLC). The mean water solubility was determined to be 470.2 g/L ± 3.6 %. All replicates showed good correspondence. Equilibration was considered to be reached after 1 day. No observations arising doubts concerning the accuracy of the results and the validity of the study were made. The result is also applicable for the water free form of the test item.