Diphosphoric acid, copper salt

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:

supporting study

Study period:

04 April 2013 - 13 May 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Qualifier:

according to guideline

Guideline:

other: OECD 436

Deviations:

not specified

Principles of method if other than guideline:

This study is submitted as supporting data as the data are taken from an acute inhalation study where the substance was ground prior to generation of an atmosphere. The study does not therefore necessarily reflect the particle size of the substance as it is placed on the market.

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of Inspection: 10 July 2012, Date of signature: 30 November 2012

Type of distribution:

other: Gravimetric

Specific details on test material used for the study:

Sponsor's identification: IP37: Copper (II)-pyrophosphate
Description: Pale green powder
CAS No. 10102-90-6
EC No. 233-279-4
Batch number: 9000022795
Purity: > 80 % (based on Cu content > 34 %)
Impurities: < 18 % water, < 2 % free othophosphate, pyrophosphate
Expiry Date: 29 September 2014
Storage conditions: Room temperature, in the dark

Mass median aerodynamic diameter:

>= 1.99 - <= 3.06 µm

Geometric standard deviation:

>= 2.14 - <= 2.67

The particle size analysis of the atmosphere drawn from the animals’ breathing zone, was as follows: 

 

Group Number	Mean Achieved Atmosphere Concentration (mg/L)	Mean Mass Median Aerodynamic Diameter (μm)	Inhalable Fraction (% <4 μm)	Geometric Standard Deviation
1	5.16	3.06	60.9	2.67
2	1.08	1.99	82.3	2.14

Conclusions:

The Mean Mass Median Aerodynamic Diameter was reported to be 3.06 μm for group 1 animals and 1.99 μm for group 2 animals. The inhalable fraction (rat) of the test material ( % <4 μm) was 60.9% for group 1 and 82.3% for group 2, which would allow the test material to reach upper and lower regions of the respiratory tract of the test animal.

Executive summary:

The Mean Mass Median Aerodynamic Diameter was reported to be 3.06 μm for group 1 animals and 1.99 μm for group 2 animals. The inhalable fraction (rat) of the test material ( % <4 μm) was 60.9% for group 1 and 82.3% for group 2, 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 key study for this endpoint.

Reference 2

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Study was completed on 18th March

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

according to guideline

Guideline:

other: European Commission Technical Guidance Document EUR 20268 ' Determination of Particle Size Distribution, Fibre Length and Diameter Distribution' of Chemical Substances (2002).

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of inspection: 10 July 2012, Date of signature: 30 November 2012

Type of method:

sieving

Type of distribution:

volumetric distribution

Specific details on test material used for the study:

-Identification: IP37: Copper (II)-pyrophosphate
- Description: Pale blue powder
- Batch number: 9000022795
- Composition: P2O5 (39.15 % w/w), CuO (43.52 % w/w)
- Expiry date: 29 September 2014
- Storage Conditions: Room temperature, in the dark

Key result

Percentile:

D90

Mean:

<= 100 µm

Remarks on result:

other: no standard deviation determined

No.:

#1

Size:

< 100 µm

Distribution:

94.6 %

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

 

Measurement	Result
Mass of test item transferred to sieve	12.52 g
Mass of test item passed through sieve	11.84 g
Proportion of test item < 100µm	94.6%

Conclusions:

The proportion of the test material having an inhalable particle size of less than 100 µm was determined to be 94.6 %, therefore the test item has been considered to be essentially inhalable.
No further particle size fractions were assessed for the test item.

Reference 3

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

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:

- Name of test material (as cited in study report): copper (II) pyrophosphate (Kupferhydroxidphosphat)

Key result

Percentile:

D99

Mean:

<= 100 µm

No.:

#1

Size:

< 100 µm

Distribution:

100 %

Conclusions:

100% of particles were found to be < 100 µm in diameter and as such the particle size distribution indicates copper(II) pyrophosphate is an inhalation risk (a significant proportion of the particles are present at < 100 µm).

Executive summary:

100 % of particles were found to be < 100 µm in diameter and as such the particle size distribution indicates copper(II) pyrophosphate 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.

Description of key information

The proportion of the test item having an inhalable size of less than 100 µm was determined to be 94.6 % using a sieve method.

Additional information

Three studies exist (company test data, MMAD as reported in an OECD 403 study and a particle size distribution study). The results from the particle size distribution study have been chosen as the key study.

The proportion of the test item having an inhalable size of less than 100 µm was determined to be 94.6 % using a sieve method, procedure designed to be compatible with European Commission Technical Guidance Document EUR 20268 ' Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances (2002)'. No further particle size fractions were assessed.