4-hydroxy-2,5-dimethylfuran-2(3H)-one

Particle size distribution (Granulometry)

Link to relevant study record(s)

Reference

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

experimental dates: 17 Oct. 2016 to 25 Jan. 2017

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The study was conducted according to OECD guideline, with minor deviations. Test substance is adequately characterised with its purity. However, as a single batch was tested, inter batch variation was not assessed. Therefore validity applies with restrictions.

Qualifier:

according to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)

Version / remarks:

1981

Qualifier:

according to guideline

Guideline:

EPA OPPTS 830.7520 (Particle Size, Fiber Length, and Diameter Distribution)

Version / remarks:

1996

Qualifier:

according to guideline

Guideline:

ISO 13320 (Particle size analysis - Laser diffraction methods)

Version / remarks:

2009

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187 (Particle Size Analysis by Laser Diffraction)

Version / remarks:

2009

GLP compliance:

yes (incl. QA statement)

Remarks:

(inspected on 11 & 12 October 2016 / signed on 28 Feb. 2017)

Type of method:

Laser scattering/diffraction

Type of particle tested:

primary particle

Type of distribution:

volumetric distribution

Percentile:

D10

Mean:

18.6 µm

St. dev.:

0.8

Percentile:

D50

Mean:

184 µm

St. dev.:

4

Percentile:

D90

Mean:

529 µm

St. dev.:

7

No.:

#1

Size:

< 500 µm

Distribution:

88.2 %

No.:

#2

Size:

< 100 µm

Distribution:

33.5 %

No.:

#3

Size:

< 10 µm

Distribution:

5.8 %

No.:

#4

Size:

< 4 µm

Distribution:

1.2 %

From each 3-fold measurement, an average value was calculated. The final result was calculated as mean value from the average values of the two samples.

 

Test series 1	D10 (µm)	D50 (Median diameter, µm)	D90 (µm)
Test 1	19.159	185.921	533.434
Test 2	19.492	191.562	539.576
Test 3	17.506	179.529	529.635
Averaged	18.682	185.658	534.294

 

Test series 2	D10 (µm)	D50 (Median diameter, µm)	D90 (µm)
Test 1	19.164	183.738	530.567
Test 2	18.457	182.196	524.290
Test 3	18.067	182.290	518.094
Averaged	18.555	182.741	524.251

Average of both test series:

D₁₀:         18.6 µm

D₅₀:         184.2 µm       (Median diameter)

D₉₀:         529.3 µm

The results in Volume % passing at 4, 10, 100 and 500 µm:

Particle size /µm	Volume under / % Average 1	Volume under / % Average 2	Volume under / % Mean
4	1.20	1.22	1.2
10	5.75	5.79	5.8
100	33.35	33.70	33.5
500	87.93	88.53	88.2

Conclusions:

The test substance contains a limited fraction of particles fine enough to be inhaled and reach the thoracic fraction.
Dust explosion potential should be considered.

Executive summary:

The granulometry of the test substance was determined under GLP according to ISO13320 and OECD 110 guidelines, with laser diffraction method, in air.

The distribution was a non-symetric Gaussian curve, with a median diameter of 184 μm.

With regard to inhalation potential, about 33.5% of total particles are smaller than 100 μm, and ca 5.8% could reach the thoracic fraction (<10 μm).

Fine particles relevant to dust explosion hazard (<500 μm) account for 88.2%.

Description of key information

Median diameter (D50) = 184 μm

Thoracic fraction (<10 μm) = 5.8 %.

Dust particles (<500 μm) = 88.2 % (dust explosion potential)

Additional information

A reliable experimental study, conducted according to a recognized OECD/ISO guideline, and under GLP, is available. Despite minor restrictions due to measurement of a single batch, it is considered as a key study.