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Administrative data

Endpoint:
relative self-ignition temperature (solids)
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with column 2 of REACH Annex VII, the self-ignition temperature study (required in section 7.12) does not need to be conducted for solids if preliminary results exclude self-heating of the substance up to 400°C:
- The substance does not melt below 450°C. No evidence of thermal reactions related to self-heating observed up to 450°C.

Furthermore, based on knowledge and experience of the substance, it is considered to be thermally stable and unreactive. This is supported by the following information:
- Substance found to be not highly flammable in the flammability study (Method A.10)
- Explosive properties predicted negative (Method A.14)
- Oxidising properties predicted negative (Method A.17).

In addition, there is no evidence of the substance having pyrophoric properties. Based on the assessment of the substance, supported by the study information above, it is considered that if a relative self-ignition temperature study (Method A.16) was conducted, no self-heating would be observed and there would be no self-ignition below the substance’s melting point. It is therefore considered unnecessary to conduct the study. Based on an assessment of the substance's properties it is concluded that it does not have self-heating or self-reactive properties.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
 Thermal analysis (differential scanning calorimetry (DSC)):  Melting point > 450 °C at 1,013 hPa (OECD 102, EU Method A.1, GLP)
Melting / freezing point at 101 325 Pa:
450 °C

The melting point study determined that the substance does not melt at temperatures below 450 °C. Visually, the samples did not change during the study. In a supporting study by Clearfield and Lehto (1988) the substance has been found to decompose before melting at very high temperatures (above 700 °C).

Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Flammability test (preliminary screening test): non-flammable (EU Method A.10, GLP)
Flammability:
non flammable

The substance is non-flammable since it failed to ignite when in contact with a bunsen flame for 2 minutes in a flammability study preliminary screening test performed in accordance with the Commission Regulation (EC) No 440/2008 of 30 May 2008, Part A, Methods for the determination of physico-chemical properties, Method A.10 Flammability. It is manufactured, stored, used and handled in ambient temperature and pressure (air) and does not ignite in these conditions. The substance is used as a water purification material (non-deionised water) and has shown no indications of ignition or reaction by releasing flammable gases when in contact with the medium. Based on an assessment of the substance's properties it is also concluded not to have self-heating or self-reactive properties. The substance can therefore be regarded as non-flammable.

The substance is classified as non-flammable as it failed to ignite in a flammability study preliminary screening test performed according to Commission Regulation (EC) No 440/2008 of 30 May 2008, Part A, Methods for the determination of physico-chemical properties, Method A.10 Flammability.

Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
explosive properties of explosives
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because there are no chemical groups present in the molecule which are associated with explosive properties
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING

In accordance with column 2 of REACH Annex VII, the explosive properties study (required in section 7.11) does not need to be conducted if there are no chemical groups associated with explosive properties present in the molecule. Therefore the explosiveness of the substance was determined by a prediction based on its structure.

The prediction was undertaken using a procedure designed to be compatible with Method A.14 Explosive Properties of Commission Regulation (EC) No 440/2008 of 30 May 2008. The results are based on the lack of chemical groups associated with explosive properties in the molecule. The lack of reactive chemical groups was determined with the assistance of the recommended literature work by Bretherick, L. (Handbook of Reactive Chemical Hazards, 4th edition, Butterworths, London, ISBN 0-750 -60103-5, 1990). The 7th edition (Academic Press) of the literature was adopted. According to the method A.14 and column 2 of Annex VII, if the substance has no reactive chemical groups, the product can be predicted to be non-explosive and the actual test does not need to be conducted.

In accordance with the literature work by Bretherick, the structure of the commercial titanate product does not indicate that there are any explosive properties associated with the product. Furthermore, the substance has failed to react when exposed to a bunsen flame for two minutes (study record 4.13 Flammability).
Reason / purpose for cross-reference:
data waiving: supporting information
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Oxidising properties test (preliminary and main test): no oxidising properties (EU Method A.17, GLP)
Oxidising properties:
no

According to the A.17 Oxidising Properties (EC No 440/2008), a substance is considered to be an oxidising substance when:

(a) in the preliminary test, there is a vigorous reaction;

(b) in the full test, the maximum burning rate of the mixtures tested is higher than or equal to the maximum burning rate of the reference mixture of cellulose and barium nitrate.

 

According to this definition the commercial product does not have oxidising properties as the commercial product's burning rates were significantly slower than the maximum burning rates obtained for the reference mixtures, and there was no vigorous reaction in the preliminary test. With sample mixtures in various ratios, the result is considered accurate. The results of the study are relevant for both the sodium and sodium/hydrogen forms of the substance.

The substance has been determined not to have oxidising properties using a procedure compatible with Method A.17 Oxidising Properties (Solids) of Commission Regulation (EC) No 440/2008. The substance is therefore not classified as oxidising.

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