lunes, 19 de mayo de 2014

REGULATORY 13/12/13 - O-Opinion on Disperse Red 17 COLIPA n° B5


Disperse Red 17 (CAS n. 3179-89-3), COLIPA n°B5, with the chemical name 1-(4'-Nitrophenylazo)-2-methyl-4-bis-(ß-hydiOxyethyl)aminobenzene, is used as a direct dye in oxidative and non-oxidative hair dye formulations.

Scientific Committee on Consumer Products SCCP adopted the opinion SCCP/1161/08. They concluded that the safety of Disperse Red 17 cannot be assessed based on the data submitted.

Submission IV for Disperse Red 17 was submitted by Cosmetics Europe in 2013. According to the applicant, it provides the toxicological study as well as information related to the chemical composition and stability of disperse Red 17.

In the concerned opinion, SCCS concluded that the use of Disperse Red 17 as an ingredient at 0.2% (inclusive of dispersant) in non-oxidative hair dye formulations, and at 2% (inclusive of dispersant) in oxidative hair dye formulations, is safe for the use by consumers.

Disperse Red 17 contains impurities which are prone to nitrosation and may generate nitrosamines. Nitrosamine content in Disperse 17 is not known but the dye should not be used in combination with nitrosating agents.
So, nitrosamine content in Disperse Red 17 should be < 50ppb, and it should not be used in the presence of nitrosating agents.

A skin painting study is available but no information concerning the possible carcinogenic potential of Disperse Red 17 in humans can be obtained.