Methyl DL-serinate hydrochloride

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 July 2014-04 July 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-compliant study in accordance with ISO 13320:2009.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: ISO 13320:2009

Deviations:

no

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. ECHA’s guidance mentions the Laser scattering/diffraction as a method suitable for all kind of particles and makes reference to ISO 13320:2009.

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Type of distribution:

volumetric distribution

Test material

Test material information

Constituent 1

Reference substance name:

Methyl DL-serinate hydrochloride

EC Number:

227-047-1

EC Name:

Methyl DL-serinate hydrochloride

Cas Number:

5619-04-5

Molecular formula:

C4H9NO3.ClH

IUPAC Name:

methyl 2-amino-3-hydroxypropanoate hydrochloride

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): DL-serine Methylester HCl
- Molecular formula: C4H9NO3.HCl
- Molecular weight: 155.58 g/mol
- Description: White crystalline powder
- Storage condition of test material: At room temperature in the dark
- Expiration date of the lot/batch: 14 September 2014

Results and discussion

Mass median aerodynamic diameter:

>= 511.091 - <= 521.74 µm

Geometric standard deviation:

>= 1.616 - <= 1.64

Particle size

Particle size 1

Percentile:

D10

Mean:

238.257 µm

St. dev.:

2.68

Particle size 2

Percentile:

D50

Mean:

440.865 µm

St. dev.:

3.13

Particle size 3

Percentile:

D90

Mean:

787.715 µm

St. dev.:

4.95

Any other information on results incl. tables

MMAD mean: 516 µm (population standard deviation: 3.82 µm)

Mode: 451 µm

 

Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.

Applicant's summary and conclusion

Conclusions:

In a GLP-compliant study in accordance with ISO 13320:2009 using the laser diffraction analysis-'wet' small volume dispersion method, the particle size distribution of the substance was determined. 0% is < 10.00 µm, 10% is < 238 µm, 50% is < 441 µm and 90% is < 788 µm. The MMAD was determined to be 516 µm.