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Environmental fate & pathways

Biodegradation in water and sediment: simulation tests

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biodegradation in water: simulation testing on ultimate degradation in surface water
Data requirement according to REACH Annex IX,
Data waiving:
study technically not feasible
Justification for data waiving:
the study does not need to be conducted because the substance is highly insoluble in water
Reason / purpose for cross-reference:
data waiving: supporting information
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study performed with scientific acceptable method
Principles of method if other than guideline:
The determination was based on the ETAD method.
This standard method was developed by intensive cooperation with the ETAD (Ecological and Toxicological Association of Dyes and Organic Pigments Manufacturers) and is regarded as acceptable for pigments by authorities.
GLP compliance:
Type of method:
flask method
Key result
Water solubility:
< 5 µg/L
23 °C
ca. 6.2
Remarks on result:
other: pH value of the water used (water deionised, 18.2MΩcm)

The stock solution was then diluted down to prepare 9 calibrations in a range between 2250 µg/L down 5 µg/L for the water solubility tests. The concentration of the additiv in water was determined by HPLC-UV.

5 μg/L was found to be the detection limit (LOD) of the method, the quantification limit (LOQ) was defined as 3 times the detection limit; therefore the LOQ is 15 μg/L in water.

Each solubility test was measured 3 times.



  Concentration (µg/L)

Test 1

Not detected

< 5

Test 2

Not detected

< 5

Test 3

Not detected

< 5

Average concentration < 5

The water solubility of test substance was determined to be <0.005 mg/L at 23°C at pH 6.2

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion