Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Not skin sensitising.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No information on the skin sensitisation potential is available for Acid Yellow 049 sodium salt. Therefore, available data on a structural analogue, i.e. Similar Substance 01, was used. Details on the read across approach are reported in section 13.

The potential of the test item to cause skin sensitisation reactions following topical application to the skin of albino guinea pigs, was assessed using the Maximization Test of B. Magnusson and A.M. Kligman (1969), according to the OECD guideline 406. None of the animals were positive after treatment with the highest non-irritant test substance concentration of 15 % in bidistilled water.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), 3.4 Respiratory or skin sensitisation section, skin sensitizer means a substance that will lead to an allergic response following skin contact.

Based on the available information, the substance can be considered as non skin sensitising.

In conclusion, the substance is not classified as skin sensitizer, according to the CLP Regulation (EC 1272/2008).