Dicopper hydroxide phosphate

Particle size distribution (Granulometry)

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

no guideline followed

Principles of method if other than guideline:

Test material was sieved in an alpine air jet sieving machine.

GLP compliance:

no

Type of method:

sieving

Type of distribution:

volumetric distribution

Specific details on test material used for the study:

- solid powder

Key result

Percentile:

D90

Mean:

< 100 µm

Remarks on result:

other: no standarddeviation was provided.

No.:

#1

Size:

< 100 µm

Distribution:

> 90 %

Conclusions:

More than 90% of particles were found to be < 100 µm in diameter.

Executive summary:

More than 90% of particles were found to be < 100 µm in diameter and as such the particle size distribution indicates dicopper hydroxide phosphate is an inhalation risk (a significant proportion of the particles are present at < 100 µm).

This study is considered to be appropriate and reliable for use as a key study in accordance with Regulation (EC) No. 1907/2006 (REACH). No further testing is required.

Reference 2

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: OECD 436

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of Inspection: 19-21 July 2011, Date of signature: 31 August 2011

Type of method:

cascade impaction

Type of distribution:

other: Gravimetric

Specific details on test material used for the study:

Sponsor's identification: Dicopper hydroxide phosphate
Description: Pale green powder
Batch number: MV 500
Purity: Neat Substance
Date received: 14 March 2012
Expiry Date: Not supplied
Storage conditions: Room temperature, in the dark

Mass median aerodynamic diameter:

3.7 µm

Geometric standard deviation:

2.43

Percentile:

D50

Remarks on result:

not measured/tested

The characteristics of the atmosphere achieved in an acute inhalation study were as follows:

 

Mean Achieved Atmosphere Concentration (mg/L)	Mean Mass Median Aerodynamic Diameter (μm)	Inhalable Fraction (% <4 μm)	Geometric Standard Deviation
5.09	3.70	53.6	2.43

 

Conclusions:

The Mean Mass Median Aerodynamic Diameter was reported to be 3.70 μm.

Executive summary:

The Mean Mass Median Aerodynamic Diameter was reported to be 3.70 μm. The inhalable fraction (rat) of the test material, % <4 μm, was 53.6 %, which would allow the test material to reach upper and lower regions of the respiratory tract of the test animal. This study is conducted according to an appropriate guideline and under the conditions of GLP, the study is therefore considered to be acceptable and to adequately satisfy both the guideline requirement and the regulatory requirement as a supporting study for this endpoint.

Description of key information

More than 90% of particles were found to be < 100 µm in diameter.

Additional information

Two studies exist (company test data and MMAD as reported in an OECD 403 study).

The sieve method used in the company test determined that more than 90% of particles were < 100 µm in diameter and as such the particle size distribution indicates dicopper hydroxide phosphate is an inhalation risk (a significant proportion of the particles are present at < 100 µm).

The results from an acute inhalation study reported the Mean Mass Median Aerodynamic Diameter to be 3.70 μm. The inhalable fraction of the test material, % <4 μm, was 53.6 %, which would allow the test material to reach upper and lower regions of the respiratory tract of the rat. In addition, this also means that a fraction of the particles will be respirable (i.e. reaching the alveoli) in humans.