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Diss Factsheets

Physical & Chemical properties

Water solubility

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Administrative data

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012-08-28 to 2012-12-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7860 (Water Solubility Generator Column Method)
Deviations:
no
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
GLP compliance:
yes
Type of method:
column elution method
Key result
Water solubility:
5.6 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
6.2

The solubility CS of Desmedipham (AE B038107), pure substance, in distilled water was determined according to the "column elution method" described in the European Commission Council Regulation (EC) No 440/2008, Annex, Part A, method A.6., OECD-Guideline 105 and US EPA Product Properties Test Guideline OCSPP 830.7840.


Due to the lack of stability of the test item in solutions with pH values > pH 4  the fractions were stabilised with small amounts of acetic acid during sampling.


The concentration of the test item Desmedipham (AE B038107) was determined by HPLC analyses.


The reversed phase HPLC method used was found to be valid.


The results of the solubility measurements are shown in the following table 1:

Conclusions:
Acceptable. Validation data has been presented. Purified substance (99.6%): Water solubility of active substance:
5.6 mg/L at 20 °C (pH = 6.2)
Executive summary:

Test Guidelines: European Commission Council Regulation (EC) No 440/2008, Annex, Part A, method A.6. OECD-Guideline 105 US EPA Product Properties Test Guideline OCSPP 830.7840


Results


The solubility CS of Desmedipham, pure substance, in distilled water was determined according to the "column elution method" described in the European Commission Council Regulation (EC) No 440/2008, Annex, Part A, method A.6., OECD-Guideline 105 and US EPA Product Properties Test Guideline OCSPP 830.7840.


Due to the lack of stability of the test item in solutions with pH values > pH 4 (Ref. 2) the fractions were stabilised with small amounts of acetic acid during sampling.


The concentration of the test item Desmedipham was determined by HPLC analyses.


The reversed phase HPLC method used was found to be valid.


The results of the solubility measurements are shown in the following table:


Water solubility of Desmedipham, pure substance:

















Solubility inFinal pHSolubility CS at 20°CRSD
Distilled water6.21)5.6 mg/L1.2 %

The sample purity (99.6 % w/w) has been taken into account.


1) Mean pH value of the neutral, not acidified fractions


 


Note regarding the pH independency of the water solubility: The partition coefficient of Desmedipham, pure substance, was found to be pH independent in the pH range of pH 4 – pH 9 . Consequently the water solubility is also pH independent in that pH range. Therefore the water solubility was determined in distilled water only

Description of key information

The solubility in distilled water was determined according to the column elution method

Key value for chemical safety assessment

Water solubility:
5.6 mg/L
at the temperature of:
20 °C

Additional information