Insulin DesB30

Surface tension

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

surface tension

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reason / purpose for cross-reference:

read-across source

Key result

Surface tension:

ca. 58 mN/m

Temp.:

20 °C

Conc.:

90 other: % saturated solution

Conclusions:

The surface tension of Insulin DesB30 was determined by read across to MI3 (S2), for which surface tension was determined by the ring method. The procedure conformed with EC Directive 92/69/EEC Method A5, and OECD Guideline 115 (1995). The calibration factor was determined to be 1.003, by measuring the surface tension of pure water at 20oC to be 72.5mN/m. The surface tension of a 90% saturated solution of MI3 was found to be 58.0 mN/m after Harkins-Jordan correction. Therefore, the same conclusion for the target substance (Insulin DesB30) applies justified by the read-across hypothesis.

Executive summary:

The surface tension of Insulin DesB30 was determined by read across to MI3 (S2). The surface tension of MI3 (solution) was determined by the ring method. The procedure conformed with EC Directive 92/69/EEC Method A5, and OECD Guideline 115 (1995). The calibration factor was determined to be 1.003, by measuring the surface tension of pure water at 20^oC to be 72.5mN/m. The surface tension of a 90% saturated solution of MI3 was found to be 58.0 mN/m after Harkins-Jordan correction. Therefore, the same conclusion for the target substance (Insulin DesB30) applies justified by the read-across hypothesis.

Reference 2

Endpoint:

surface tension

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000.03.16 – 2000.09.18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 115 (Surface Tension of Aqueous Solutions)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

ring method

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL (MI3 solution)
- Appearance: brown paste
- Source and lot/batch No.of test material: QC202426
- Expiration date of the lot/batch: June 2004
- Purity test date: 2003-06-18
- Purity: 84% w/w (stated ny Sponsor)

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Frozen below - 10°C

Key result

Surface tension:

ca. 58 mN/m

Temp.:

20 °C

Conc.:

90 other: % saturated solution

The calibration factor was determined to be 1.003, by measuring the surface tension of pure water at 20 oC to be 72.5mN/m.

The surface tension of a 90% saturated solution of MI3 was found using a White Instrument Surface Tension (torsion) Balance to be 58.0 mN/m after Harkins-Jordan correction.

Conclusions:

The surface tension of MI3 (solution) was determined by the ring method. The procedure conformed with EC Directive 92/69/EEC Method A5, and OECD Guideline 115 (1995). The surface tension of a 90% saturated solution of MI3 wasfound using a White Instrument Surface Tension (torsion) Balance to be 58.0 mN/m

Executive summary:

The surface tension of MI3 (solution) was determined by the ring method. The procedure conformed with EC Directive 92/69/EEC Method A5, and OECD Guideline 115 (1995). The calibration factor was determined to be 1.003, by measuring the surface tension of pure water at 20^oC to be 72.5mN/m. The surface tension of a 90% saturated solution of MI3 was found using a White Instrument Surface Tension (torsion) Balance to be 58.0 mN/m after Harkins-Jordan correction.

Description of key information

Data on target substance not available. Thus, read-across has been applied using data from source substances (S2).

As can be seen from the molecular structure (see attached document in section 13) the target substance is a small protein consisting of 50 amino acids have at least 49 amino acids in common with the source substances (consisting of 50-53 amino acids) and having very identical amino acid sequences. Based on these structural similarities very similar physical chemical properties would be expected. This is further documented by the results from physical chemical guideline testing for S2 and S3 where the test results found for melting point, boiling point, flammability, self-ignition, and explosion were identical.

Specifically, for the S2 substance the surface tension of a 90% saturated solution of MI3 was found to be 58.0 mN/m after Harkins-Jordan correction

Key value for chemical safety assessment

Surface tension:

58

Additional information

The surface tension of MI3 (solution) was determined by the ring method. The procedure conformed with EC Directive 92/69/EEC Method A5, and OECD Guideline 115 (1995). The calibration factor was determined to be 1.003, by measuring the surface tension of pure water at 20^oC to be 72.5mN/m. The surface tension of a 90% saturated solution of MI3 was found to be 58.0 mN/m after Harkins-Jordan correction. Therefore, the same conclusion for the target substance (Insulin DesB30) applies justified by the read-across hypothesis.