2-ketogluconic acid, calcium salt

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: sieving

Version / remarks:

As suggested in the integrated testing strategy for granulometry, 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 5.0, December 2016, the granulometry of Stimulhyal was assessed by sieving through a sieve with 100 µm aperture width.

Principles of method if other than guideline:

A test sieve with a certified aperture width of 100 µm (VWR collection, serial no. 15175141, conform to DIN ISO 3310, NF ISO 3310, ISO 565, ASTM E11, BS 410) with the corresponding collection pan was used in the present study.

The collecting pan was weighed; the test sieve was inserted into the corresponding collecting pan. An exact quantity of test substance, e.g. 10.00 g, was weighed to the setup.

The test substance was sieved by mechanical agitation for 5 minutes. The amount of test substance collected in the collecting pan was determined. The operation was repeated until the weight of the test substance in the collecting pan did not change by more than 5%.

GLP compliance:

not specified

Other quality assurance:

ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)

Type of method:

sieving

Type of particle tested:

aggregate

Type of distribution:

counted distribution

Test material

Test material information

Constituent 1

Reference substance name:

2-ketogluconic acid, calcium salt

EC Number:

919-553-2

Cas Number:

28098-92-2

Molecular formula:

C6H10O7.xCa

IUPAC Name:

2-ketogluconic acid, calcium salt

Test material form:

solid

Results and discussion

Particle size

Key result

Percentile:

D95

Mean:

< 100 µm

St. dev.:

0.95

Applicant's summary and conclusion

Conclusions:

The tested sample of Stimulhyal contains virtually no particles with a particle size of <100 µm. 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.