2,4-Thiophenedicarbonitrile, 5-amino-3-methyl-

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 November 2009 to 4 December 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of distribution:

volumetric distribution

Test material

Test material information

Constituent 1

Reference substance name:

5-amino-3-methylthiophene-2,4-dicarbonitrile

EC Number:

610-868-8

Cas Number:

52603-48-2

Molecular formula:

C7N3H5S

IUPAC Name:

5-amino-3-methylthiophene-2,4-dicarbonitrile

Results and discussion

Particle size

Percentile:

D50

Remarks on result:

other: Too few particles were of a size less than 10.0 µm to allow accurate assessment of the mass median aerodynamic diameter.(migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)

Particle size distribution at different passages

Particle size distribution at different passages 1

No.:

#1

Size:

< 100 µm

Distribution:

93.2 %

Particle size distribution at different passages 2

No.:

#2

Size:

< 10 µm

Distribution:

5.65 %

Remarks on result:

other: Mean value based upon three separate determinations.

Particle size distribution at different passages 3

No.:

#3

Size:

< 5.5 µm

Distribution:

1.68 %

Remarks on result:

other: Mean value based upon three seperate determinations.

Any other information on results incl. tables

Too few particles were of a size less than 10.0 µm to allow accurate assessment of the mass median aerodynamic diameter. Sampling for the cascade impactor determinations was performed by rolling the test material container for approximately 10 minutes then sampled from the top, middle and bottom. The inhalable fraction is defined as the mass fraction of particles which can be inhaled by nose or mouth, the thoracic fraction is defined as the mass fraction of particles that passes the larynx and the respirable fraction is defined as the mass fraction of particles that reaches the alveoli.

Applicant's summary and conclusion

Conclusions:

Particle size data for the test material is as follows:
Proportion of test material having an inhalable particle size less than 100 µm: 93.2%
Proportion of test material having a thoracic particle size less than 10.0 µm: 5.65%
Proportion of test material having a respirable particle size less than 5.5 µm: 1.68%

Executive summary:

Particle size data have been acquired using a procedure designed to comply with the European Commission technical guidance document "Particle Size Distribution, Fibre Length and Diameter Distribution" (June 1996), which satisfies the requirements of OECD Guideline 110.

The results are as follows:

Proportion of test material having an inhalable particle size less than 100 µm: 93.2% (sieve method)

Proportion of test material having a thoracic particle size less than 10.0 µm: 5.65% (Cascade Impactor method)

Proportion of test material having a respirable particle size less than 5.5 µm: 1.68% (Cascade Impactor method)