Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-[bis(2-hydroxyethyl)amino]-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)

Endpoint summary

Description of key information

Not skin irritating.

Not eye irritating.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

No specific tests on the substance under registration was performed, nevertheless the substance belongs to the Stilbene Fluorescent Whitening Agents category, group 3, in which all members share the common organic functional group dihydroxyethylamino derivative, with different sulphonation degrees: acid form (OB 3a-A(free acid), disulphonated sodium salt (OB 3a-A(Na), disulphonated sodium/potassium form (OB 3a-A(NaK) tetrasulphonated (OB 3a-MSA). An analogue substance from group 1, OB 1 -DSA is also used.

For three representative substances valid tests were conducted according to internationally accepted testing guidelines and no effect for skin and eye irritation according to CLP Regulation was recorded.

The conclusion on the irritation potential for the substance under registration can be traced interpolating the results for the other substances: the less water soluble OB 3a-A(Na)/OB 3a-A(NaK) and the more water soluble (OB 3a-MSA) as well of OB 1 -DSA

Within the whole category ten over fourteen registered substances were tested and none of the existing tests arisen any concern for skin and eye irritation.

All substances of the category were modelled with OECD Toolbox and the estimated results about skin and eye irritation were calculated for all members. No alerts were reported (see category Justification Report attached to the section 13 of the technical dossier) for any substance. The same was performed for the substance and a common behaviour regarding this end point within the category was observed.

Read across within the same subgroup is well justified in this case also taking into account the impurities of the considered substances, since the identified organic impurities can have different substitution on the molecule, but the functional reactive groups are potentially the same, and molecules are of the same molecular size and polarity of the main component. As a consequence the systemic absorption and reactivity is practically the same than the main constituent and Read Across is justified.

Based on all those considerations, the available studies on the analogous substances are representative for the substance under registration that can then be considered not irritant for skin and eye.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), 3.2 Skin corrosion/irritation section, skin Irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.

In all the studies available, the mean values from gradings at 24, 48 and 72 hours were lower than 2.3 in at least 2 of 3 animals for both erythema/eschar and oedema reactions.

According to the CLP Regulation (EC 1272/2008) substances that have the potential to induce reversible eye irritation are classified in Category 2 (irritating to eyes) if, when applied to the eye of an animal, a substance produces at least in 2 of 3 tested animals, a positive response of corneal opacity ≥ 1 and/or iritis ≥ 1, and/or conjunctival redness ≥ 2 and/or conjunctival oedema (chemosis) ≥ 2, calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.

The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for irtitis, lower than 2 for both conjunctival redness and oedema, in all animals.

In conclusion, the available experimental data is adequate for classification and labelling and the substance is not classified for the eye and skin irritation, according to the CLP Regulation (EC 1272/2008).