Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

The skin sensitization potential for similar substance 2 was assessed (TFL, 1989).

The purpose of this skin sensitization study was to assess the allergenic potential of the substance when administered to the skin of male and female albino guinea pigs.

For this purpose the Maximization-Test of B. Magnusson and A.M. Kligman (1969) was used. Ten animals (5 males, 5 females) were treated with the vehicle alone (petrolatum oil) and 20 animals (10 males, 10 females) were treated with the test article.

Due to the unequivocal findings observed after the first challenge, no second challenge was performed. The tested substance was assessed to be not sensitizing

Therefore Acid Brown 348 is to be considered as not-sensitizing for read across with similar substance 2.

Read Across is described in detail in section 13.


Migrated from Short description of key information:
Not sensitizing

Justification for selection of skin sensitisation endpoint:
The study has been performed on a similar substance

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

According to the CLP Regulation (EC 1272/2008), for Guinea Pig Maximisation test, substances should be classified in accordance with the following criteria:

skin sens cat 1: if < 0.1 intradermal, >30% positive animals or >0.1 to <1% intradermal, >60% positive animals

Skin sens cat 2: >0.1 to <1% intradermal >30 to <60% positive animals >1% intradermal , >30% positive animals

As there are no positive animals, the substance does not meet the criteria to be classified as skin sensitizing.

Justification for classification or non-classification

No classification for sensitisation is warranted under Regulation CE 1272/2008.