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Diss Factsheets

Administrative data

Endpoint:
surface tension
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because water solubility is below 1 mg/L at 20°C
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with column 2 of REACH Annex VII, the surface tension study (required in section 7.6) does not need to be conducted if the water solubility is below 1 mg/L at 20 °C. The substance's water solubility is less than or equal to 0.89 mg/L at 20 °C as determined in the Water Solubility test.

Furthermore, in accordance with the test guidelines
- Method A5 Surface Tension of Commission Regulation (EC) No 440/2008 of 30 May 2008
- Method 115 of the OECD Guidelines for Testing of Chemicals, 27 July 1995,
the surface tension of substances with a water solubility of less than 1 mg/L need not be tested for surface tension.
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24.5.-11.9.2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was performed by following the recommended methods (Method A6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995) and GLP.
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
yes
Remarks:
The flask method was used even though the method recommends the column elution method for test items with a solubility < 10 mg/L.
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
yes
Remarks:
The flask method was used even though the method recommends the column elution method for test items with a solubility < 10 mg/L.
GLP compliance:
yes (incl. QA statement)
Remarks:
Certificate is included in the study report
Type of method:
flask method
Water solubility:
<= 0.89 mg/L
Temp.:
20 °C
pH:
>= 6.32 - <= 6.48
Remarks on result:
other: T = 20.0 ± 0.5 °C
Details on results:
The final concentration was calculated based on the iron and cobalt concentrations in the samples:
Concentration Range:
- 4.35 x 10^-4 to 8.90 x 10^-4 g/L based on cobalt solubility
- 1.93 x 10^-4 to 5.32 x 10^-4 g/L based on iron solubility.
Overall Result : ≤ 8.90 x 10^-4 g/L at 20.0 ± 0.5 ºC

The cobalt concentration (g/L) in the sample solutions is shown in the following table:

Sample Number

Time Shaken at ~ 30 ⁰C (hours)

Time Equilibrated at 20 ⁰C (hours)

Concentration

(g/L)

Mean

Concentration

(g/L)

Test Item

Mean

Concentration

(g/L)

Solution pH

1A

24

24

8.87 x 10^-5

8.90 x 10^-5

5.27 x 10^-4

6.32

1B

24

24

8.93 x 10^-5

2A

48

24

1.49 x 10^-4

1.50 x 10^-4

8.90 x 10^-4

6.48

2B

48

24

1.51 x 10^-4

3A

3B

72

72

24

24

7.34 x 10^-5

7.34 x 10^-5

7.34 x 10^-5

4.35 x 10^-4

6.33

The iron concentration (g/L) in the sample solutions is shown in the following table:

Sample Number

Time Shaken at ~ 30 ⁰C (hours)

Time Equilibrated at 20 ⁰C (hours)

Concentration

(g/L)

Mean

Concentration

(g/L)

Test Item

Mean

Concentration

(g/L)

Solution pH

1A

24

24

4.83 x 10^-5

4.83 x 10^-5

3.02 x 10^-4

6.32

1B

24

24

4.83 x 10^-5

2A

48

24

8.46 x 10^-4

8.52 x 10^-4

5.32 x 10^-4

6.48

2B

48

24

8.58 x 10^-4

3A

3B

72

72

24

24

3.03 x 10^-5

3.15 x 10^-5

3.09 x 10^-5

1.93 x 10^-4

6.33

Conclusions:
During the preliminary study the water solubility of the test item was estimated to be 0.558 mg/L. Method A6 Water solubility (440/2008/EC) recommends that the column elution method should be used if the water solubility is < 1x10^-2 g/L. However, since the substance is insoluble in organic solvents, the column elution method could not be applied.

Using the flask method, the water solubility of the test item has been determined to be less than or equal to 8.90 x 10-4 g/L of solution at 20.0 ± 0.5 °C. The substance is therefore poorly soluble in water.
Executive summary:

The water solubility of the substance was determined to be less than or equal to 8.90 x 10^-4 g/L of solution at 20.0 ± 0.5 °C, using the flask method, designed to be compatible with Method A6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion