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EC number: 500-011-5 | CAS number: 9003-80-9
Water solubility
Administrative data
Link to relevant study record(s)
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 September 2015 to 12 October 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- Organization for Economic Co-operation and Development (OECD), OECD Guidelines for the Testingof Chemicals no. 105: "Water Solubility", July 27, 1995.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- European Community (EC), EC no. 260/2014, Part A: Methods for the Determination of Physico-Chemical Properties, Guideline A.6: “Water Solubility”, Official Journal of the European Union no. L81, March 19, 2014.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7840 (Water Solubility)
- Version / remarks:
- United States Environmental Protection Agency (EPA), Product Properties Test Guidelines no.OPPTS 830.7840: "Water Solubility: Column Elution Method; Shake Flask Method", March 1998.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- column elution method
- Specific details on test material used for the study:
- Identification: Formaldehyde, oligomeric reaction products with acetone and diphenylamineAppearance: Dark brown flakesBatch: IC5B04P006Purity/Composition: 100% Unknown or Variable compositions, Complex reaction products and Biological materials (UVCB)Test item storage: At room temperatureStable under storage conditions until: 26 February 2019 (expiry date)Purity/composition correction factor: No correction factor requiredTest item handling: No specific handling conditions required
- Water solubility:
- >= 0.276 - <= 1.48 mg/L
- Conc. based on:
- test mat.
- Temp.:
- 20 °C
- pH:
- > 6.4 - < 8.1
- Details on results:
- The turbidity of the eluates was < 0.2 NTU. According to this, no undissolved particles were detected in the eluates.The test item was quantified based on diphenylamine; obtained concentrations should therefore be interpreted as an upper limit of the water solubility. Structure-related reaction products of higher molecular weight will exhibit even lower water solubility. Slightly different values were observed for the different flows used in column elution. At 24 ml/h the water solubility was 0.276 mg/l and at 12 ml/h it was 0.401 mg/l. At a flow rate of 6 ml/h the average water solubility was 1.48 mg/l. Results, however, fluctuated: while the measured concentration increased in the initial 4 samples, it subsequently decreased to a value below 1 mg/l. This fluctuation may be attributed to the complex composition of the test item.
- Conclusions:
- The water solubilities of the test item were 0.276 mg/l, 0.401 mg/l and 1.48 mg at a flow rate of 24 ml/h, 12 ml/h and 6 ml/h respectively. As quantification was based on diphenylamine, these concentrations should be interpreted as a maximum water solubility; test-item components with a molecular weight higher than diphenylamine will exhibit even lower water solubility. Slight differences between different flow rates and fluctuations in concentration at the lowest flow rates were deemed acceptable in view of the complex composition of the test substance and the low concentration level.
- Executive summary:
The water solubility of Formaldehyde, oligomeric reaction products with acetone and diphenylamine was determined using column elution, performed in accordance with the following guidelines:
European Community (EC), EC no. 260/2014, Part A: Methods for the Determination of Physico-Chemical Properties, Guideline A.6: “Water Solubility”, Official Journal of the European Union no. L81, March 19, 2014.
Organization for Economic Co-operation and Development (OECD), OECD Guidelines for the Testing of Chemicals no. 105: "Water Solubility", July 27, 1995.
United States Environmental Protection Agency (EPA), Product Properties Test Guidelines no. OPPTS 830.7840: "Water Solubility: Column Elution Method; Shake Flask Method", March 1998.
Three different flows were tested. Column elution was performed at Charles River Den Bosch. The concentrations of the collected water-solubility samples were determined at ABL.
The column elution method was applied for the determination of the water solubility of Formaldehyde, oligomeric reaction products with acetone and diphenylamine.
The water solubilities of the test item were 0.276 mg/l, 0.401 mg/l and 1.48 mg at a flow rate of 24 ml/h, 12 ml/h and 6 ml/h respectively. As quantification was based on diphenylamine, these concentrations should be interpreted as a maximum water solubility; test-item components with a molecular weight higher than diphenylamine will exhibit even lower water solubility. Slight differences between different flow rates and fluctuations in concentration at the lowest flow rates were deemed acceptable in view of the complex composition of the test substance and the low concentration level.
The pH of the aqueous samples was 6.4 – 8.1.
Reference
Main study – water solubility of the test item
Flow rate [ml/h] | Concentration analysed | pH | |
Mean1[mg/l] | CV [%] | ||
24 12 6 | 0.276 0.401 1.48 | 10 4.8 24 | 8.1 8.1 6.4 |
Description of key information
Key value determined in a GLP accredited laboratory study using column elution method, in accordance with OECD Guideline 105, EU Method A.6 and US EPA Procedure OPPTS 830.7840.
Key value for chemical safety assessment
- Water solubility:
- 0.276 mg/L
- at the temperature of:
- 20 °C
Additional information
Three different flows were tested. Column elution was performed at Charles River Den Bosch. The concentrations of the collected water-solubility samples were determined at ABL.
The column elution method was applied for the determination of the water solubility of Formaldehyde, oligomeric reaction products with acetone and diphenylamine.
The water solubilities of the test item were 0.276 mg/l, 0.401 mg/l and 1.48 mg at a flow rate of 24 ml/h, 12 ml/h and 6 ml/h respectively. As quantification was based on diphenylamine, these concentrations should be interpreted as a maximum water solubility; test-item components with a molecular weight higher than diphenylamine will exhibit even lower water solubility. Slight differences between different flow rates and fluctuations in concentration at the lowest flow rates were deemed acceptable in view of the complex composition of the test substance and the low concentration level.
The pH of the aqueous samples was 6.4 – 8.1.
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