Registration Dossier

Administrative data

Endpoint:
surface tension
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2019-01-15 - 2019-03-21(experimental phase: 2019-02-06)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 115 (Surface Tension of Aqueous Solutions)
Version / remarks:
OECD Guideline 115 dated 27. July 1995 “Surface tension of aqueous solutions“
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.5 (Surface Tension)
Version / remarks:
Commission Regulation (EC) No. 440/2008, from 30. May 2008, published on 31. May 2008, EU-Method A.5 “Surface Tension“
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Landesamt für Umwelt, Kaiser-Friedrich-Straße 7, 55116 Mainz, Germany
Type of method:
plate method

Test material

Constituent 1
Reference substance name:
Yucca schidigera, ext.
EC Number:
607-033-5
Cas Number:
223749-05-1
IUPAC Name:
Yucca schidigera, ext.
Test material form:
solid: particulate/powder
Remarks:
fine beige
Details on test material:
Storage: Room Temperature (20 ± 5 °C)
Homogeneity: homogeneous
Specific details on test material used for the study:
The test item was stored in the test facility in a tightly closed vessel at room temperature (16.2 – 22.6 °C).

Results and discussion

Surface tension
Key result
Surface tension:
>= 36.45 - <= 41.71 mN/m
Temp.:
20 °C
Conc.:
1 g/L
Remarks on result:
other: surface-active

Applicant's summary and conclusion

Conclusions:
The study was performed according to OECD TG 115 and EU Method A.5 (GLP) with no deviation and is therefore considered to be of the highest quality (reliability Klimisch 1). The surface tension of the negative control was determined with a difference of 0.02 % from the calculated value. So the results are considered sufficiently reliable to assess the surface activity of the test item.
The values of the single determinations of the aqueous solution of the test item showed a significant difference (> 5%) at the repetition measurement series after one hour. Therefore, a third experiment was conducted after two hours. The difference to the second series was 2.11 % therefore the plateau was reached.
All measured values lay below the threshold for surface tension which is stated in the guidelines.
Therefore, the result of the test is considered valid and the test item Yucca schidigera, ext. is classified as “surface active” in a concentration of 1.00 g/L.
Executive summary:

The surface tension of an aqueous solution of Yucca schidigera, ext. was determined under GLP in a study according to OECD TG 115 and EU Method A.5 at the plateau after the second measurement as 37.44 ± 0.24 mN/m at 20.0 °C.

The values of the single determinations of the aqueous solution of the test item showed a significant difference (> 5%) at the repetition measurement series after one hour. Therefore, a third experiment was conducted after two hours. The difference to the second series was 2.11 % therefore the plateau was reached.

As these values were below 60 mN/m, Yucca schidigera, ext. was classified as surface active.

The surface tension of the negative control lay within the accepted range.