Registration Dossier

Administrative data

Endpoint:
surface tension
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Testing was conducted between 26 October 2009 and 19 November 2009.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.5 (Surface Tension)
Deviations:
yes
Remarks:
Please see Principles of method if other than guidelines.
Principles of method if other than guideline:
The determination was carried out using a White Electrical Institute interfacial tension balance and a procedure based on the ISO 304 ring method. With the exception of the following deviation, the experimental procedure used complied with that specified in Method A5 Surface Tension of Commission Regulation (EC) No 440/2008 of 30 May 2008.
1) The surface tension result was not corrected using the Harkins-Jordan correction table as the correction is not applicable to the apparatus used. Once calibrated, the balance and ring assembly used in this test give a direct reading for surface tension that is within the required accuracy (± 0.5 mN/m); this is as a result of the reduced ring dimensions.
This deviation has been considered not to have affected the integrity of the study.
GLP compliance:
yes (incl. certificate)
Remarks:
Date of inspection: 19-08-2008 Date of Signature: 04-09-2009
Type of method:
other: The determination was carried out using a White Electrical Institute interfacial tension balance and a procedure based on the ISO 304 ring method.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sponsor's identification: DMH
Description: white crystalline solid
Batch number: N5439431
Date received: 24 February 2006
Storage conditions: room temperature in the dark

Results and discussion

Surface tension
Surface tension:
71.6 mN/m
Temp.:
21.2 °C
Conc.:
1 g/L

Any other information on results incl. tables

Calibration factor (Φ)

The readings, temperatures and the corresponding calibration factors for glass double-distilled water are shown in the following table:

Table 7.2

Reading (mN/m)

Temperature (ºC)

Literature Value (mN/m)

Calibration Factor

72.5

21.0

72.57

1.001

72.5

21.0

72.57

1.001

72.5

21.0

72.57

1.001

72.5

21.0

72.57

1.001

72.5

21.0

72.57

1.001

72.5

21.0

72.57

1.001

72.5

21.0

72.57

1.001

Mean Calibration Factor = 1.001

Sample solution readings

The readings, times and temperatures for the sample solution are shown in the following table:

Table 7.3

Time (mins)

Reading (mN/m)

Temperature (ºC)

113

71.5

21.0

132

71.5

21.0

147

71.5

21.0

157

71.5

21.0

169

71.5

21.0

187

71.5

21.0

Mean reading:           71.5 mN/m
Surface tension
      =         reading x calibration factor
            =         71.5 x 1.001
            =         71.6 mN/m
Temperature:
           21.0 ± 0.5ºC
pH of sample solution
:       6.33

Applicant's summary and conclusion

Conclusions:
The surface tension of a 1.00 g/l solution of test material has been determined to be 71.6 mN/m at 21.0 ± 0.5°C. The test material is considered not to be a surface-active material.
Executive summary:

Method

The determination was carried out using a White Electrical Institute interfacial tension balance and a procedure based on the ISO 304 ringthod. With the exception of the following deviation, the experintal procedure used complied with that specified in Method A5 Surface Tension ofCommissionRegulation (EC) No 440/2008 of 30 May 2008.The surface tension result was not corrected using the Harkins-Jordan correction table as the correction is not applicable to the apparatus used. Once calibrated, the balance and ring assembly used in this test give a direct reading for surface tension that is within the required accuracy (± 0.5 mN/m); this is as a result of the reduced ring dimensions.

This deviation has been considered not to have affected the integrity of the study.

Conclusion

The surface tension of a 1.00 g/l solution of test material has been determined to be 71.6 mN/m at 21.0 ± 0.5°C. The test material is considered not to be a surface-active material.