Sodium Salts of (1-Hydroxyethylidene)bisphosphonic acid (2-3 Na:1)

Particle size distribution (Granulometry)

Link to relevant study record(s)

Reference

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-04-12

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

June 1996

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

sieving

Type of particle tested:

aggregate

Type of distribution:

mass based distribution

No.:

#1

Size:

< 100 µm

Distribution:

0.165 %

Remarks on result:

other: The particle size distribution was not determined for the respirable size rane (<10 µm) due to the very few particles present in the inhalable size rane (<100 µm). Therefore, further testing was considered not necessary.

Results

Screening test (Sieve Method):

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

Measurement	Result
Mass of test item transferred to sieve	12.15 g
Mass of test item passed through sieve	0.02 g
Proportion of test item <100 µm	0.165%

Discussion:

The particle size distribution was not determined for the respirable size rane (<10 µm) due to the very few particles present in the inhalable size rane (<100 µm). Therefore, further testing was considered not necessary.

Conclusions:

The proportion of the test item have particle size of <100 µm was determined to be 0.165%. The test item was therefore considered to be essentially non inhalable.

Executive summary:

The proportion of test item having an inhalable particle size of less than 100 µm was determined to be 0.165%, acquired using a procedure designed to comply with the European Commission technical guidance docunt 'Particle Size Distribution, Fibre Length and Diater Distribution' (June 1996), which satisfies the requirents of OECD Guideline 110. The test item was therefore considered to be essentially non-inhalable.

Description of key information

Particle size distribution (solid): non-inhalable due to proportion of HEDP (2-3Na) having inhalable particle size of <100 determined to be 0.165%.

Particle size distribution (aqueous solution) The endpoint is not relevant to substances not used or marketed in a non-solid form

Additional information

For the anhydrous form of the substance which is a solid under ambient conditions, the proportion of HEDP (2-3Na) having an inhalable particle size of <100 µm was determined to be 0.165% using a sieve method in accordance with OECD Test Guideline 110 and in compliance with GLP. Therefore, the solid form of HEDP (2-3Na) is considered essentially non-inhalable. The result is considered to be reliable.

Or companies to enter their own company specific data for solid forms [CONFIDENTIAL].