1-Octadecanamine, reaction products with 1,1'-methylenebis[4-isocyanatobenzene]

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 16 July 2012 and 26 November 2012.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

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. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Principles of method if other than guideline:

The method used is based on a procedure designed to be compatible 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, 12 May 1981.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

PU Thickener

IUPAC Name:

PU Thickener

Test material form:

other: Beige solid pieces

Details on test material:

Identification: PU Thickener
Description: Beige solid pieces
Purity: > 98%
Expiry / Retest Date: 14 June 2015
Storage Conditions: Room temperature, in the dark

Results and discussion

Particle size

Percentile:

D50

Remarks on result:

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

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 3.11

 

Measurement	Result
Mass of test item transferred to sieve	10.54 g
Mass of test item passed through sieve	0.06 g
Proportion of test item <100 µm	0.569%

Applicant's summary and conclusion

Conclusions:

The proportion of test item having an inhalable particle size of less than 100 µm was determined to be 0.569%. The test item has been considered to be essentially non-inhalable.

Executive summary:

The method used is based on a procedure designed to be compatible 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, 12 May 1981.

   

Discussion

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.

 

Conclusion

The proportion of test item having an inhalable particle size of less than 100 µm was determined to be 0.569%. The test item has been considered to be essentially non-inhalable.