GAMMA-CYCLODEXTRINE, 6A,6B,6C,6D,6E,6F,6G,6H-OCTABROMO-6A,6B,6C,6D,6E,6F,6G,6H-OCTADEOXY-

Surface tension

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

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:

08 January 2016 - 06 June 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to other study

Remarks:

validated analytical method used for quantification of the water samples

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Version / remarks:

2014

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Version / remarks:

1995

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 830.7840 (Water Solubility)

Version / remarks:

1998

Deviations:

no

GLP compliance:

yes

Type of method:

column elution method

Water solubility:

0.657 mg/L

Temp.:

20 °C

pH:

6.2

Remarks on result:

other: Flowrate 24 mL/h. Mean of 10 samples. CV= 11%.

Water solubility:

0.715 mg/L

Temp.:

20 °C

pH:

6.3

Remarks on result:

other: Flowrate 12 mL/h. Mean of 10 samples. CV= 3.6%.

Key result

Water solubility:

0.686 mg/L

Temp.:

20 °C

pH:

>= 6.2 - <= 6.3

Remarks on result:

other: mean value (maximum difference= 8.5%)

Details on results:

The coefficient of variation (CV) (n=10) was ≤ 30% at both flow rates. It demonstrated that the system was equilibrated at all flow rates.

The maximum difference on the mean values at both flow rates was ≤ 30%. The water solubility of the substance is given as the mean value of these measurements: 0.686 mg/L.

Small responses at the retention time of the test item were found in the samples from the blank column at both flow rates. This was probably caused by carry-over since a higher response was found in the analytical blank.The maximum contribution to the samples at a flow rate of 24 mL/h was 0.2% and 0.5 % to the samples at a flow rate of 12 mL/h. It was considered that it has no significant effect on the results of the test samples.

Conclusions:

The water solubility at 20°C was determined to be 0.686 mg/L.

Executive summary:

The water solubility of the substance was determined using the column elution method in a GLP study according to EC A.6, OECD 105 and OPPTS 830.7840.

Quantification was performed by UPLC-MS/MS. The water solubility at 20°C was determined to be 0.686 mg/L. The pH of the aqueous samples was 6.2 -6.3.