Registration Dossier

Administrative data

Description of key information

Skin irritation:
In a OECD guideline and GLP compliant primary skin irritation test in rabbits, the test item (Pigment Red 112) caused grade 0-1 erythema and edema after 30-60 minutes, while neither erythema nor edema were observed 24, 48 and 72 hours after application of the test substance. Therefore, Pigment Red 112 was regarded as not skin irritating.
Eye irritation:
In a OECD guideline and GLP compliant primary eye irritation test in rabbits, the test item (Pigment Red 112) caused grade 1 (1/3 animals) chemosis after one hour and conjunctival reddening grade 1 (3/3 animals) after 1 hours and grade 1 (1/3 animals) after 24 hours. No effects were observed for these and other parameters at the other reading times up to 72 hours. Therefore, Pigment Red 112 was regarded as not eye irritating.
Respiratory tract:
Study was waived; substance is not classified for this endpoint. The substance is considered not to exert any special local irritative or systemic adverse effects; the substance is considered likely to behave like an inert dust.
Non-human information: This information is not available.
Human information: No human information is available

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)

Additional information

The results of the skin irritation key study (Hoechst, 1983) are supported by several other primary skin irritation tests in rabbits (Hoechst, 1979a; 1979b; 1979c; Ciba-Geigy, 1972; Reseach Institute for Organic Syntheses, 2007) showing only very slight to mild, transient irritating effects on rabbit skin under the study conditions. In all studies, the strength of the reactions was well below classification-relevant thresholds. The fact that the observation period was not prolonged until full reversibility was achieved in one study in which in one animal a grade 1 reaction was still observed at 72 hours (end of observation period) is not considered relevant for the classification decision because the irritation effects were clearly subsiding over the observation period and the substance was clearly non-irritating in all other studies.

The results of the eye irritation key study (Hoechst, 1983) are reported by several other primary eye irritation tests in rabbits (Hoechst, 1979a; 1979b; 1979c; Ciba-Geigy, 1972; Reseach Institute for Organic Syntheses, 2007) showing either no, very slight or mild to moderate, transient irritating effects on the rabbit eye under the study conditions. In all studies, the strength of the reactions was well below classification-relevant thresholds. The fact that the observation period was not prolonged until full reversibility was achieved in one study in which grade 1 reactions were still observed at 72 hours (end of observation period) is not considered relevant for the classification decision because the irritation effects were clearly subsiding over the observation period and the substance was clearly non-irritating in all other studies.

Justification for classification or non-classification

Pigment Red 112 has been tested in vivo for irritative properties in several skin irritation tests in rabbits. The substance caused only slight, transient irritation to the skin. The individual and group mean of scores read 1, 2 and 3 days after treatment were well below the classification criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC). Therefore, Pigment Red 112 does not have to be classified as skin irritating.

 

Pigment Red 112 has been tested in vivo for irritative properties in several eye irritation tests in rabbits. The substance caused no or only slight, transient irritation to the eyes. The individual and group mean of scores read 1, 2 and 3 days after treatment were well below the classification criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC). Therefore, Pigment Red 112 does not have to be classified as eye irritating.

 

It can reasonably be deduced that Pigment Red 112 does not cause respiratory tract irritation and thus does not have to be classified according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC), because Pigment Red 112 did cause only slight, fully reversible irritative effects in the eyes and on the skin and does not have to be classified as either skin or eye irritating. Moreover, Pigment Red 112, in the unlikely event of being inhaled as a dust, is considered not to cause more severe effects than an inert dust, because its chemical inertness and extremely low solubility in water and n-octanol largely prevent interaction with living cells and tissues.