19-norpregn-4-en-20-yn-3-one, 17-hydroxy-7-methyl, (7alpha, 17alpha-)

Appearance / physical state / colour

Administrative data

Endpoint:

appearance / physical state / colour

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 September 2017 - 14 February 2018

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 same study

Reference

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 September 2017 - 14 February 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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)

Version / remarks:

Handbook K, 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/Fibre Length 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 when density is known.

GLP compliance:

yes (incl. QA statement)

Remarks:

dd 13 January 2016

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: 1.18
Test item was tested as received.

Mass median aerodynamic diameter:

374.313 µm

Geometric standard deviation:

>= 3.271 - <= 3.409

Remarks on result:

other: The MMAD above is the average of 5 runs. GSD was calculated from d50/d15.78. The min. and max. GSD values of 5 runs are provided above. The St.dev. in the table below is the population standard deviation [µm].

Key result

Percentile:

D10

Mean:

53.528 µm

St. dev.:

1.032

Remarks on result:

other:

Remarks:

std. dev. of the population

Key result

Percentile:

D50

Mean:

344.583 µm

St. dev.:

5.142

Remarks on result:

other:

Remarks:

std. dev. of the population

Key result

Percentile:

D90

Mean:

786.632 µm

St. dev.:

15.699

Remarks on result:

other:

Remarks:

std. dev. of the population

No.:

#1

Size:

< 10 µm

Distribution:

0.76 %

Remarks on result:

other:

Remarks:

volume of sample

Conclusion of visual and microscopic evaluation:

- visual observation: fine off-white powder with some fines and clusters

- observation using 3.2 objective lens: irregular shaped crystals (range of individual particle size was approximately 10 μm - approximately 560 μm).

- observation using 40 objective lens: single crystalline particles.

Laser Diffraction Particle Size Analysis:

Coefficient of variation for D50 is < 3%; D10 and D90 are < 5%.

Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320 standard.

Conclusions:

Particle size distribution of the substance was determined as follows: D10 = 53.528 µm, D50 = 344.583 µm and D90 = 786.632 µm.
0.76% by volume was determined to be smaller than 10 µm.
The MMAD was calculated to be 374.313 µm.

Executive summary:

The particle size distribution of the substance was determined using laser diffraction analysis (dry powder module) in a GLP study according to ISO 13320 and CIPAC MT 187. Each result is the average of five runs. D10 = 53.528 µm, D50 = 344.583 µm and D90 = 786.632 µm. 0.76% by volume was determined to be smaller than 10 µm. The MMAD was calculated to be 374.313 µm.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The appearance was determined by visual observation (direct and under a microscope). No guideline was followed for the appearance determination but sufficient details were given in the study report.

GLP compliance:

yes (incl. QA statement)

Remarks:

dd 13 January 2016

Test material

Test material information

Constituent 1

Reference substance name:

19-norpregn-4-en-20-yn-3-one, 17-hydroxy-7-methyl, (7alpha, 17alpha-)

EC Number:

601-419-7

Cas Number:

1162-60-3

Molecular formula:

C21H28O2

IUPAC Name:

19-norpregn-4-en-20-yn-3-one, 17-hydroxy-7-methyl, (7alpha, 17alpha-)

Test material form:

solid: particulate/powder

Details on test material:

- Physical appearance: off-white to beige powder
- Test item storage: at room temperature

Results and discussion

Physical state at 20°C and 1013 hPa:

solid

Form / colour / odour

Key result

Form:

solid: particulate/powder

Colour:

Off-white to beige

Odour:

other: not determined

Substance type:

organic

Any other information on results incl. tables

A test substance sample was observed to be a medium to coarse, off-white to beige powder with some fines and clusters.

From observations using a 3.2 objective lens, the particles appeared to be irregular shaped crystals.

From observations using a 40 objective lens, the sample was observed to be made up of single crystalline particles.

Applicant's summary and conclusion

Conclusions:

The substance is an off-white to beige powder at room temperature.