Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled, oligomerisation products with 1-chloro-2,3-epoxypropane

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

flask method

Water solubility:

>= 0.89 - <= 1.77 mg/L

Temp.:

20 °C

pH:

>= 5.34 - <= 5.77

Conclusions:

In a GLP-study according to OECD Test Guideline 105, the water solubility of the registered substance was 0.89 – 1.77 mg/L at 20.0 ± 0.5 °C, hence the substance is slightly soluble (0.1-100 mg/L)

Executive summary:

The solubility of CARDOLITE NC-513 in water was determined from the measured concentrations of DOC in the filtrated test solutions and the carbon content in the test item (79.07 %).

The preliminary study which is described in the guideline was not performed as water solubility of the test item was estimated as < 10 mg/L in a non-GLP pre-test (measured in a solution with the nominal concentration of the test item 100 mg/L).

In the first experiment, 50 – 1001 mg/L test item in water were used for the test. Eight individual flasks (1A – 1E and 2 – 4) were prepared. Five test vessels (flasks 1D (for sampling date 4 days), 1E (7 days) and 2 – 4) and the blank were set onto the shaking apparatus immediately. After 24 ± 2 hours, flask 1C (for the sampling point 72 h), after further 24 ± 2 hours, flask 1B (for the sampling point 48 h) and after further 24 ± 2 hours, flask 1A (for the sampling point 24 h) were set on the shaker and all flasks were shaken for further 24 ± 2 hours at room temperature (20.0 ± 0.5 °C). Then, flasks 1A – 1D were taken from the shaker and stored at 20.0 ± 0.5 °C for equilibration. Samples were taken, membrane filtrated (0.45 µm, PTFE) and analysed for TOC via TOC analyser. The measured values lay below the LOQ of the instrument (1.13 mg/L). Therefore, the samples were sent to the laboratory Henkel for the determination of DOC using TOC-L CSH analyser with LOQ of TOC 0.1 mg/L together with the filtrated solutions from flasks 1E and 2 – 4 on day 7. As in the blank value, 0.45 mg/L DOC concentration was measured and the deviation between flasks 1A – 1E was too high, the first experiment was not valid and the values were not used in the calculation of the test item concentration. It is presumed, that the vessels for the delivery were contaminated.

In the second experiment, the same procedure was performed. Equilibration time was considered as approx. four days, as the value which was measured on the following consecutive seventh day did not give different values.

All replicates showed poor correspondence (RSD of 38 %), as dependency of solubility on amount of the test item (nominal load) was perceived, but no linear dependency was observed.

The solubility of the test item CARDOLITE NC-513 in demineralised water lay in the range 0.89 – 1.77 mg/L at 20.0 ± 0.5 °C

for the following nominal concentration range of the test item in water: 50 – 1001 mg/L.

Description of key information

water solubility (determined using OECD 105, flask method; GLP): 0.89 – 1.77 mg/L at 20.0 ± 0.5 °C

Key value for chemical safety assessment

Water solubility:

1.77 mg/L

at the temperature of:

20 °C

Additional information

In a GLP-study according to OECD Test Guideline 105, the water solubility of the registered substance was 0.89 – 1.77 mg/L at 20.0 ± 0.5 °C