4-[(4-{[4-({5-[2-(acryloyloxy) ethoxy]-5-oxoalkanoyl}oxy) benzoyl]oxy}-2-methylaroxy)carbonyl] aryl 2-(acryloyloxy) ethyl alkandioate

Appearance / physical state / colour

Administrative data

Endpoint:

appearance / physical state / colour

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Reference

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 October 2017 - 22 November 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

ISO 13320 (Particle size analysis - Laser diffraction methods)

Version / remarks:

2009

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187 (Particle size analysis by laser diffraction), Handbook K

Version / remarks:

2007

Deviations:

no

Principles of method if other than guideline:

According to REACH 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 regulation (EC) No 440/2008. OECD 110 TG ‘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 Guidance on information requirements and Chemical Safety Assessment-Chapter R.7a stipulates that many methods are available for particle size measurements but none of them is applicable to the entire size range. The guidance mentions Laser scattering/diffraction as a method for particles of all kind and makes reference to ISO 13320:2009.
According to Guidance document EUR 20268 (2002), the laser diffraction technique is applicable to particles of respirable and inhalable size. The MMAD can be calculated.

GLP compliance:

yes (incl. QA statement)

Remarks:

certificate issued: 13 January 2016 (by MHRA UK)

Type of method:

Laser scattering/diffraction

Type of particle tested:

primary particle

Type of distribution:

volumetric distribution

Specific details on test material used for the study:

relative density: 1.39
The substance was tested as received.

Mass median aerodynamic diameter:

16.659 µm

Remarks on result:

other: standard deviation of the population = 0.133 µm (0.8%)

Key result

Percentile:

D10

Mean:

7.749 µm

St. dev.:

0.077

Remarks on result:

other: st.dev. of the population

Key result

Percentile:

D50

Mean:

14.13 µm

St. dev.:

0.113

Remarks on result:

other: st.dev. of the population

Key result

Percentile:

D90

Mean:

24.644 µm

St. dev.:

0.248

Remarks on result:

other: st.dev. of the population

No.:

#1

Size:

< 10 µm

Distribution:

22.92 other: vol%

VISUAL OBSERVATION

- The substance was observed (by eye) to be a a fine powder which formed into many clusters and lumps.

- At magnification under a microscope using 3.2 objective lens, the particles appeared to be irregular shapes crystals. The smallest individual particle size was approximately < 10 μm and the largest individual size was approximately 38 μm.

- At magnification under a microscope using 40 objective lens, the sample was observed to be made up of single crystalline particles.

DISPERSANT TRIALS

- water: substance not soluble but sample clumped together

- acetone: soluble

- methanol: soluble

- kerosene: substance not soluble and sample well dispersed (for at least 120 minutes; concentrations tested: 1.5 and 5.0 mg/30 mL)

LASER DIFFRACTION ANALYSIS

Coefficient of variation for D50 is < 3%; D10 and D90 are < 5%. These values are within the acceptable limits mentioned in the ISO 13320 standard.

volume weighted mean = 15.353 μm

mode = 14.531 μm

Conclusions:

Particle size distribution of the substance: D10= 7.749 µm, D50= 14.13 µm and D90= 24.644 µm. 22.92% by volume was determined to be smaller than 10 µm.
The MMAD was determined to be 16.659 µm.

Executive summary:

The particle size distribution of the substance was determined using laser diffraction analysis (small volume wet module) in a GLP study according to ISO 13320 and CIPAC MT 187.

Each result is the average of five runs:

D10= 7.749 µm, D50= 14.13 µm and D90= 24.644 µm.

22.92% by volume was determined to be smaller than 10 µm.

The MMAD was determined to be 16.659 µm.

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Appearance was determined by visual observation.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Details on test material:

- Physical appearance: white powder with lumps
- Test item storage: at room temperature protected from light

Specific details on test material used for the study:

observed as received

Results and discussion

Physical state at 20°C and 1013 hPa:

solid

Form / colour / odour

Key result

Form:

solid: particulate/powder

Colour:

white

Odour:

other: not determined

Substance type:

organic

Applicant's summary and conclusion

Conclusions:

The substance was visually observed to be a fine white powder with clusters and lumps.