Tetrasodium enneatitanium icosaoxide hydrate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING

In accordance with column 2 of REACH Annex VIII, the acute toxicity by inhalation study (required in section 8.5.2) does not need to be conducted if in addition to the oral route (8.5.1), the information is provided for at least one other route. Acute toxicity data by dermal route (8.5.3) has been recorded for the substance in the IUCLID endpoint 7.2.3 Acute tocixity: dermal.001. 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.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Calculation: vapour pressure less than 1.2 x 10^-9 Pa at 25 °C (EU Method A.4 Part A, OECD 104)

Vapour pressure:

0 Pa

at the temperature of:

25 °C

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 before melting at temperatures above 700 °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.

Cross-reference 2

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Mass based distribution (100 μm sieve): particle size of less than 100 μm: 1.01 - 2.92 % (EC EUR 20268, GLP)

A screening test consisting of sieving a known amount of test item with a 100 μm mesh concluded that only 2.92 % of the sodium form test item passed through the sieve and are inhalable. Only 1.01 % of the sodium/hydrogen form test item passed through the sieve and are 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.