Registration Dossier

Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 18, 2013 - July 17, 2014
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is not a guideline study but is well documented and meets generally accepted scientific principles. Relevance: the particle size distribution is not a REACH requirement as the substance is only marketed and used in a non-solid form.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
According to REACH Regulation (EC) No 1907/2006 Article 13(3) tests on substances shall be conducted in accordance with the test methods laid down in a Commission Regulation or in accordance with other international test methods recognised by the Commission or the Agency as being appropriate. No particle size distribution test method is laid down in the relevant Regulation (EC) No 440/2008. The international OECD 110 test guideline ‘Particle Size Distribution/FibreLength and Diameter Distributions’ dates from 1981 and describes two methods in detail; both methods have restrictions and are not applicable to the entire size range. ECHA’s document ‘Guidance on information requirements and Chemical SafetyAssessment-Chapter R.7a: Endpoint specific guidance’ stipulates that many methods are available for particle size measurements but none of them is applicable to the entire size range.

For the particle size determination of this substance, manual sieve analysis was performed using different sieve sizes. Optical and SEM images are provided to confirm particle size.

GLP compliance:
no
Type of method:
sieving
Type of distribution:
mass based distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Name of test material (as cited in study report): Disodium Isodecyl Sulfosuccinate
Description: white powder
Storage conditions of test material: at room temperature in well-sealed container
The substance was tested as received.

Results and discussion

Particle size
Percentile:
D50
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.

Any other information on results incl. tables

Table: Results of the manual sieve analysis

Sieve size [µm]

Weight (g)

wt%

>710

6.44

31.96

425 – 710

5.07

25.16

300 – 425

3.95

19.60

150 – 300

2.51

12.46

75 – 150

1.99

9.88

44 – 75

0.07

0.35

< 44

0

0

% substance recovered:

99.4%

Applicant's summary and conclusion

Conclusions:
Using manual sieve analysis, it was determined that approx. 89% of the test substance is >150 µm, ca 10% is between 44 and 150 µm and 0% is < 44 µm.

The particle size distribution is not a REACH requirement as the substance is only marketed and used in a non-solid form. The particle size distribution test was performed on test substance that was specially prepared for REACH purposes.