1,7-Naphthalenedisulfonic acid, 4-amino-3-[(1E)-2-(2,4-disulfophenyl)diazenyl]-5-hydroxy-6-[(1E)-2-(4-nitro-2-sulfophenyl)diazenyl]-, sodium salt (1:5)

Endpoint summary

Description of key information

SKIN IRRITATION/CORROSION STUDY: 
Was performed in a GLP laboratory in accordance with established and prescribed EU, OECD, US and Japanese test methods. The results were evaluated according to Regulation (EC) No 1272/2008, No skin irritation was caused by 4 hours exposure to the test substance. 
EYE IRRITATION STUDY: 
Study was performed at a GLP laboratory in accordance with prescribed OECD, EU, US and Japanese test guidelines. A minor deviation from the daily mean relative humidity occurred however this deviation was determined not to affect the validity of the study. Some irritation was observed in all three animals but had completely resolved within 72 hours in one animal and within 7 days in the other two animals. Irritation of the iris was found in one animal and had resolved within 24 hours.

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

SKIN IRRITATION / CORROSION STUDY:

A study was performed at a GLP laboratory in accordance with prescribed OECD, EU, US and Japanese test guidelines. A minor deviation from the daily mean relative humidity occurred however this deviation was determined not to affect the validity of the study.

Three rabbits were exposed to 0.5 grams of the test substance, moistened with water by application onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were assessed 1, 24, 48 and 72 hours after exposure.

The results were evaluated according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (including all amendments). No skin irritation was caused by 4 hours exposure to the test substance.

An additional study was of the skin corrosion potential of the test substance was performed as per the methods set out in OECD 431 and EU method B.40 BIS. The study was performed at a GLP laboratory and no deviations from the test guidelines were recorded.

It is concluded that this test is valid and that the test substance is not corrosive in the in vitro skin corrosion test under the experimental conditions.

EYE IRRITATION STUDY:

Study was performed at a GLP laboratory in accordance with prescribed OECD, EU, US and Japanese test guidelines. A minor deviation from the daily mean relative humidity occurred however this deviation was determined not to affect the validity of the study. Single samples of approximately 82 mg of the test substance were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours and/or 7 days after instillation. Instillation of the test substance resulted in irritation of the conjunctivae and iris both of which had completely reversed by the end of the study. The results of the study were evaluated in accordance with Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments); it was determined that the test substance does not have to be classified.

Justification for selection of skin irritation / corrosion endpoint:
Study was performed at a GLP laboratory in accordance with prescribed OECD, EU, US and Japanese test guidelines. A minor deviation from the daily mean relative humidity occurred however this deviation was determined not to affect the validity of the study.
The results were evaluated according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (including all amendments). No skin irritation was caused by 4 hours exposure to K1600 black dye.

Justification for selection of eye irritation endpoint:
Study was performed at a GLP laboratory in accordance with prescribed OECD, EU, US and Japanese test guidelines. A minor deviation from the daily mean relative humidity occurred however this deviation was determined not to affect the validity of the study.
Based on these results, the test substance does not have to be classified and has no obligatory labelling requirement for eye irritation according to the:
- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures
(including all amendments).

Justification for classification or non-classification

SKIN IRRITATION STUDY:

The results of a valid in-vitro study conducted in accordance with EU and OECD test guidelines conclueded that the test substance was not corrosive to skin. Furhter to this, the results of a valid in-vivo study conducted in a GLP laboratory in accordance with EU, OECD, US and Japanese test guidelines were evaluated according to Regulation (EC) No 1272/2008, No skin irritation was caused by 4 hours exposure to the test substance. The critieria for classification as skin irritant were not met.

EYE IRRITATION STUDY:

An in-vivo study was conducted to investigate the eye irritation potential of the test substance. The study was conduceted in a GLP laboratory with a minor deviation which was determined not to affect the validity of the study. The results were evaluated in accordance with Regulation (EC) No. 1272/2008; it was determined that the test substance was not classified as an eye irritant.