Registration Dossier

Administrative data

Description of key information

The substance was not irritating to skin as tested in rabbits upon 24h exposure (Ciba-Geigy Ltd 1979a). Weight-of-evidence from the BfR eye irritation inclusion and exclusion rules and from a study in rabbits (Ciba-Geigy Ltd 1979b) as well as an in-vitro study with a
reconstructed three dimensional human cornea model (EpiOcular™) (BASF 2012b) indicate that the substance is not irritating to eyes.

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 was tested by 24h application onto shaved rabbit skin (Ciba-Geigy Ltd 1979). The substance was suspended in a mixture of 70% polyethylene glycol and 30% saline and both intact and abraded skin were used. Three males and three females were treated. Draize scores for 24h, 48h and 72h were both 0 for intact and abraded skin. Therefore, the substance is considered to be non irritating to skin.

For eye irritation, a weight-of-evidence approach was used because none of the existing data on its own is sufficient for classification and labelling. Poorly documented company data indicating absence of irritating properties in rabbits was retrieved (Synthesia 1989). In addition, a detailed report showing absence of eye irritation was available; however the study was performed in 1972 at a contract research laboratory that was known to have falsified study reports in previous years. Therefore, the study is not taken as a key study, although otherwise it is suited in regard to procedure and reporting details.

The test item is a poorly soluble organic pigment for which in general irritating properties have not been observed so far. Organic pigments from different classes consistently show absence of irritating properties as they are insoluble in water or organic solvents.

Pigment Red 177 was subjected to the eye irritation rules of the German Bundesinstitut für Risikobewertung (BfR) and found to fulfill no inclusion criteria, but several exclusion criteria.

In order to verify absence of irritating effects, an in-vitro study was performed (BASF 2012b).

As the only OECD guideline for eye irritation available can only distinguish highly irritating substances from irritating substances, another in-vitro study had to be applied. The chosen assay uses a reconstructed three dimensional human cornea model (EpiOcular™). It has been validated at the performing laboratory to distinguish a non irritant from an irritant. Viability of the tissue is determined after a 90 min exposure plus an 18h recovery period. Any substance causing a reduction in viability of more than 50% is considered to be an irritant. As Pigment Red 177 did not reduce the viability compared to water, it was found to be non irritating in this assay.

Therefore, the overall conclusion in a weight-of-evidence approach is that Pigment Red 177 is not irritating to eyes.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin or eye irritation under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EG.

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No. 1272/2008, as amended for the third time in Directive EC 618/2012.