Tetrasodium enneatitanium icosaoxide hydrate

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

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.

Results and discussion

Target system / organ toxicity

Critical effects observed:

not specified