5,5-dimethylhydantoin

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Testing was conducted between 26 October 2009 and 19 November 2009.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted 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:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

The method used is designed to comply with that given in ‘Particle Size Distribution, Fibre Length and Diameter Distribution’, June 1996 European Commission technical guidance document, which satisfies the requirements of OECD Guideline 110.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of inspection: 19-08-2008 Date of Signature: 04-09-2009

Type of distribution:

other: The method used is designed to comply with that given in ‘Particle Size Distribution, Fibre Length and Diameter Distribution’, June 1996 European Commission technical guidance document, which satisfies the requirements of OECD Guideline 110.

Test material

Test material information

Constituent 1

Reference substance name:

DMH

IUPAC Name:

DMH

Details on test material:

Sponsor's identification: DMH
Description: white crystalline solid
Batch number: N5439431
Date received: 24 February 2006
Storage conditions: room temperature in the dark

Results and discussion

Particle size

Particle size 1

Percentile:

D50

Mean:

other: As only a small amount passed through the 100µm sieve, the test material was considered to be essentially non-inhalable.

Remarks on result:

other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.

Particle size 2

Mean:

other: Not applicable

Particle size distribution at different passages

No.:

#1

Size:

> 100 µm

Distribution:

4.09 %

Any other information on results incl. tables

Results

 Screening test (sieve method)

The results of the sieving procedure are shown in the following table:

Table 10.1

Measurement	Result
Mass of test material transferred to sieve	12.22g
Mass of test material passed through sieve	0.50g
Percentage of test material less than 100 µm	4.09%

Applicant's summary and conclusion

Conclusions:

The proportion of test material having a particle size less than 100µm has been determined to be 4.09%. The test material is essentially non-inhalable.

Executive summary:

Method

The method used is designed to comply with that given in ‘Particle Size Distribution, Fibre Length and Diameter Distribution’, June 1996 European Commission technical guidance document, which satisfies the requirements of OECD Guideline 110.

Procedure

Screening test (sieve method)

Test material (12.22 g) was sieved for approximately 30 minutes on an Inclyno sieve shaker using a 100 µm sieve. The mass of test material passing through the sieve was measured.

Conclusion

The proportion of test material having a particle size less than 100µm has been determined to be 4.09%. The test material is essentially non-inhalable.