Tetrasodium 4-amino-5-hydroxy-6-[[2-methoxy-5-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]-3-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate

Oxidising properties

Link to relevant study record(s)

Reference

Endpoint:

oxidising solids

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 oxidising properties and hence, the classification procedure does not need to be applied

Qualifier:

according to guideline

Guideline:

EU Method A.17 (Oxidising Properties (Solids))

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: European Commission Regulation (EC) No 1907/2006 (REACH), Annex VII and ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7a.

Deviations:

no

Principles of method if other than guideline:

Statement

GLP compliance:

no

Other quality assurance:

ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)

 

Discussion and result

In accordance with Regulation (EC) No. 1907/2006, annex VII, the study does not need to be conducted if on the basis of the chemical structure the test item is assumed as incapable of reacting exothermically with combustible materials. According to the information requirement 7.13 of the REACH regulation and according to the ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7a this applies to organic substancesnot containing oxygen or halogen atoms and these elements are not chemically bonded to nitrogen or oxygen and to inorganic substances not containing oxygen or halogen atoms.

Composition of the test item

The composition of the test item is described in the certificate of analysis (20140325rev1), dated March 25, 2015, Siemens AG Prozess-Sicherheit, Industriepark Höchst, 65926 Frankfurt am Main, Germany. A summary of the composition of the test item is given in Table 1.

Table 1: Test item composition

Constituent	Content in % (w/w)
NaCl	9.4
Na2SO4	11.1
NaO(OC)CH3	0.4
NaNO3	0.3
H2O	7.2
Total inorganic impurities^1)	28.4
Main constituent^2)	41.7
Organic impurities≥1 % (w/w)^2)	26.1
Organic impurities < 1 % (w/w)^2)	3.9
Total organic constituents^3)	71.6

¹⁾ Minor constituents < 0.1 % (w/w) were not taken into account.

²⁾ Estimated by means of HPLC measurements at (254 nm)

³⁾ Under the assumption of a total peak area of 100 %.

Structural evaluation of the test item

According to the guidelines mentioned above, the structures of the organic main constituent and the organic impurities were evaluated regarding to “not containing oxygen or halogen atoms and these elements are not chemically bonded to nitrogen or oxygen” and the structures of the inorganic impurities were evaluated regarding to “not containing oxygen or halogen atoms”.

Organic constituents:

The chemical structures of the main constituent and the organic impurities (≥1 w/w % estimated by means of HPLC) of the test item are given in the attached background material.

The structures of the organic main constituent and the organic impurities contain amongst other atoms oxygen atoms. The oxygen atoms are not chemically bonded to oxygen or nitrogen in the molecules. Halogen atoms are not included in their chemical structures.

Inorganic constituents:

The inorganic impurity NaCl does not contain any oxygen or halogen atom in its structure.

 

The inorganic impurities Na₂SO₄, NaO(OC)CH_3, NaNO₃ and H₂O all contain one or more oxygen atoms in their structures. The three compounds Na₂SO₄, NaO(OC)CH₃and H₂O are well known and investigated and have no oxidizing properties according to Gestis-Stoffdatenbank (www.dguv.de/ifa/stoffdatenbank).

 

The inorganic impurity NaNO₃contains three oxygen atoms bonded to nitrogen in its structure and is known to be an oxidizer. Nevertheless, as the content of NaNO₃in the test item was very low (0.3 % (w/w)), this minor impurity would not influence the test on oxidising properties. This is in accordance with the expert knowledge of the scientists of the Siemens AG, Process Safety.

 

Therefore, regarding the structural evaluation of the test item, oxidising properties can be excluded according to the information requirement 7.13 of the REACH regulation and according to the ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7a.

Interpretation of results:

GHS criteria not met

Conclusions:

Regarding the structural evaluation of the test item, oxidising properties can be excluded according to the information requirement 7.13 of the REACH regulation and according to the ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7a.

Executive summary:

The test item had no oxidising properties according to Regulation (EC) No. 1907/2006, annex VII.

Description of key information

No oxidising properties

Key value for chemical safety assessment

Oxidising properties:

no

Additional information

In accordance with column 2 of REACH Annex VII, this study does not need to be conducted as this substance is incapable of reacting exothermically with combustible materials on the basis of its chemical structure. The material does not contain any functional groups which may indicate oxidizing properties. Therefore, it can be concluded by expert judgement that this substance has no oxidizing properties in the sense of EC Guideline A 21. The determination according to EC Guideline A 21 is not necessary.