Sophorolipids: fermentation products of glucose and rapeseed-oil fatty acids methyl esters with yeast Candida Bombicola

Particle size distribution (Granulometry)

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

particle size distribution (granulometry)

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is marketed or used in a non solid or granular form

Percentile:

D50

Remarks on result:

other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.

Reference 2

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: DIN ISO 3310

GLP compliance:

no

Type of method:

other: mechanical agitation

Type of particle tested:

primary particle

Type of distribution:

counted distribution

Key result

Percentile:

other: not specified

Mean:

0 µm

St. dev.:

0

Remarks on result:

other:

Remarks:

The tested sample of Freeze dried Sopholiance contains virtually no particles with a particle size of <100 um. According to the integrated testing strategy for granulometry, as outlined in Figure R.7.1-6 of the above-mentioned guidance document, further testing is therefore not necessary.

Conclusions:

The tested sample of Freeze dried Sopholiance contains virtually no particles with a particle size of <100 um. According to the integrated testing strategy for granulometry, as outlined in Figure R.7.1-6 of the above-mentioned guidance document, further testing is therefore not necessary.

Description of key information

A study does not need to be conducted if the substance is marketed or used in a non solid or granular form. Commercial samples of the registered substance are produced as aqueous solutions. Thus, in practice the study can be waived. However, because a freeze-dried sample was obtained for the determination of a number of other physical-chemical properties the granulometry of Freeze dried Sopholiance was assessed by sieving through a sieve with 100μm aperture width. In three independent trials, the weight percentage of particles with a size < 100μm was 0.0%. It was therefore concluded that the tested sample of Freeze dried Sopholiance contains virtually no particles with a particle size of < 100μm.

Further testing is therefore not necessary according to the integrated testing strategy for granulometry, as outlined in Figure R.7.1.6 of the ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7a: Endpoint specific guidance, Version 6.0, July 2017.