Reaction product of diazotized 3-aminobenzenesulfonic acid coupled with naphthalen-1-amine, subsequently diazotized and coupled with 3-((ethyl(phenyl)amino)methyl)benzenesulfonic acid or 4-((ethyl(phenyl)amino)methyl)benzenesulfonic acid, sodium salt

Endpoint summary

Description of key information

Skin: not irritating, not corrosive
Eye: severe eye irritant

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:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation/corrosion

The potential of the test item to be irritant to the skin was investigated through an in vitro skin irritation study using a commercial reconstructed human epidermis (RhE) model named EPISKIN™. The experimental procedures are based on the OECD Guideline for testing of chemicals no. 439.

The test item did not induce cell death in any replicate, the mean cell viability after appropriate subtraction was 83.5% when compared to the negative control. The substance is considered not irritant to the skin.

Eye irritation/corrosion

An vitro study was performed to assess the corneal damage potential of the substance, according to the OECD Guideline for the Testing of Chemicals, Method No. 437 and the EU Method B. 47.

The test item could not be completely rinsed off the cornea. Therefore the opacity measurement after removal of the test item was not completely correct. The opacity values were very high and probably false positive due to the remaining test item on the cornea. But the permeability measurement was that high, even if the opacity measurement would have been completely negative, the substance is classified in category I, due to the high permeability of the cornea caused by the test item.

Under the conditions of the study, the test item induced serious eye damage on the cornea of the bovine eye.

The calculated IVIS (in vitro irritancy score) is 389.21.

Justification for classification or non-classification

Skin irritation/corrosion

Three in vitro skin irritation test methods based on reconstructed human epidermis (RHE) technology have been recently accepted by the OECD in the OECD TG 439. They serve to reliably distinguish non-irritants from irritant substances.

The EpiSkinTM and EpiDermTM assays have undergone formal ECVAM validation from 2003–2007 (Spielmann et al, 2007).

In 2007 the EpiSkinTM assay was considered valid by ESAC as a full replacement test (ECVAM/ESAC, 2007).

According to the Decision logic for classification of substances ( Guidance on the Application of the CLP Criteria, June 2015), data from a suitable in vitro test, and existing and relevant data can provide sound conclusive evidence that the substance is an skin irritant or non irritatant substance. According to the results of the test OECD 439, and the CLP Regulation n. 1272/2008, the substance can be not classified as a skin irritant/skin corrosive.

Eye irritation/corrosion

The OECD has at present adopted three in vitro tests for the identification of substances inducing serious eye damage, i.e. the Isolated Chicken Eye (ICE) test (OECD TG 438; TM B.48), the Bovine Corneal Opacity and Permeability (BCOP) test (OECD TG 437; TM B.47) and the Fluorescein Leakage (FL) test (OECD TG 460). These tests are recommended for use as part of a tiered-testing strategy for regulatory classification and labelling (e.g. Top-Down Approach). A substance can be considered as causing serious eye damage (Category 1) based on positive results. Negative results from the ICE and BCOP test methods can be used for classification purposes i.e. ‘bottom-up approach’.

There are currently no validated in vitro eye irritation test methods available.

According to the Decision logic for classification of substances ( Guidance on the Application of the CLP Criteria, June 2015), data from a suitable in vitro test ( (adopted by OECD or not), and existing and relevant data can provide sound conclusive evidence that the substance is an eye severe irritant or eye non irritant substance.

According to the results of the OECD 437 test, and the CLP Regulation n. 1272/2008, the substance can be classified as a classify as severe eye irritant, Eye Dam. 1, H318.