Dipotassium hexacyanocobalt(II)-ferrate(II)

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

short-term repeated dose toxicity: inhalation

Data waiving:

exposure considerations

Justification for data waiving:

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING

In accordance with column 2 of REACH Annex VIII, the most appropriate route of administration, having regard to the likely route of human exposure, should be selected for the short-term repeated dose toxicity study (required in section 8.6.1). Testing by inhalation route was not deemed appropriate, as the calculated vapour pressure of the substance is very low (less than 1.2 x 10^-9 Pa), and the particle size of the substance is so large that it excludes any likely exposure through inhalation. This route of exposure is therefore not relevant for the substance. Instead, the study is performed for the oral route and documented in the IUCLID endpoint 7.5.1.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

vapour pressure

Type of information:

calculation (if not (Q)SAR)

Remarks:

Migrated phrase: estimated by calculation

Adequacy of study:

key study

Study period:

14.05.2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The calculation method is detailed in the following guidelines: - Method A.4 of Commission Regulation (EC) No 440/2008 of 30 May 2008, Part A Methods for the determination of physico-chemical properties - Method 104 of the OECD Guidelines for Testing of Chemicals, 23 March 2006

Reason / purpose for cross-reference:

reference to other study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

EU Method A.4 (Vapour Pressure)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 104 (Vapour Pressure Curve)

Deviations:

no

GLP compliance:

not specified

Type of method:

other: Calculation

Key result

Temp.:

25 °C

Vapour pressure:

< 0 Pa

Remarks on result:

other: Estimation (calculation)

Transition / decomposition:

yes

Remarks:

decomposition

Transition temp.:

> 230 - ca. 300 °C

Conclusions:

In accordance with column 2 of REACH Annex VII, the vapour pressure study (required in section 7.5) does not need to be conducted if the melting point is above 300 °C. The substance's melting point is > 450 °C as determined in the Melting/Freezing Temperature test performed according to test guidelines. The substance has also been found to decompose at 230-300 °C and therefore it was not deemed necessary to perform the actual study. An estimation was, however, thought to be informative for the consideration of human exposure through air. Through calculation the vapour pressure of the substance has been estimated to be less than 1.2 x 10^-9 Pa at 25 °C.

Executive summary:

The vapour pressure of the substance has been calculated to be less than 1.2 x 10^-9 Pa at 25 °C using a procedure detailed in Method A.4 of Commission Regulation (EC) No 440/2008 of 30 May 2008, Part A: Methods for the determination of physico-chemical properties and Method 104 of the OECD Guidelines for Testing of Chemicals, 23 March 2006. The actual study does not need to be conducted.

Cross-reference 2

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24.5.-11.9.2014

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The determination was carried out using a procedure designed to be compatible with that given in European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’, 2002 and the results can therefore be thought of as reliable with restrictions. A known amount of test item was sieved with a mesh of 100 μm and the percentage of test item to pass through the sieve was calculated. According to the Integrated testing strategy for granulometry (Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance Version 3.0, August 2014) no further testing is necessary if there are virtually no particles with diameters below 100 μm. The study is GLP compliant.

Qualifier:

according to guideline

Guideline:

other: European Commission 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:

Certificate included in the study report.

Type of method:

sieving

Type of distribution:

mass based distribution

Key result

Remarks on result:

other: The percentage of test item having an inhalable particle size of less than 100 μm was determined to be 1.05%. The test item has been considered to be essentially non-inhalable.

No.:

#1

Size:

ca. 100 µm

Distribution:

ca. 1.05 %

Remarks on result:

other: The percentage of test item having an inhalable particle size of less than 100 μm was determined to be 1.05%. The test item has been considered to be essentially non-inhalable.

Conclusions:

A screening test consisting of sieving a known amount of test item with a 100 μm mesh concluded that only 1.05 % of the test item passed through the sieve and is inhalable. According to the Integrated testing strategy for granulometry (Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance Version 3.0, August 2014) no further testing is necessary. The test item is 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 by a sieve method to be 1.05%. Particle size data was acquired using a procedure designed to be compatible with that given in European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’, 2002. The test item is considered to be essentially non-inhalable.

Results and discussion

Target system / organ toxicity

Critical effects observed:

not specified