Registration Dossier

Administrative data

Description of key information

In a primary skin irritation study no irritating effects were observed in six rabbits (BASF, 1978). Eye irritation was assessed in a weight of evidence approach of three available studies showing no to slight irritation within the first 24 hours after exposure. Reversibility of irritation was seen in two studies with an observation period of 7 to 8 days.

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

Data for C.I. Pigment Green 50 (spinel pigment based on cobalt (II)/nickel (III)/zinc titanate) are not available. Thus read across was performed with C.I. Pigment Yellow 53 (nickel antimony titanium yellow). The two Nickel-containing pigments belong to a family of spinel and rutile pigments that have been tested for ion leaching (please refer to IUCLID section 7.9.3) and have been exempted from classification based on non-availability of ion toxicophores. The heavy metal oxides (used for Pigment manufacturing) are absorbed by the spinel resp. rutile lattice and thus lose their chemical, physical, and physiological properties. Both pigments show a very low water solubility (< 0.05 mg/L) being practically physiologically inert. Thus, it can be concluded, that the chemical behaviour towards the different toxicological endpoints is similar for both pigments. Therefore all toxicological endpoints were addressed with C.I. Pigment Yellow 53.

Skin irritation

Following the experimental design according to Federal Register 38, No. 187, § 1500.41, S. 27019, 27. Sept. 1973, 0.5 mL of a 50 % solution of the test substance with water was applied to the intact and abraded skin of six rabbits (BASF, 1978). Evaluation of erythema after 24 hours was not possible due to treatment related staining for the intact skin. Erythema and oedema were not observed on the intact skin of the six rabbits after occlusive dressing for 24 hours of exposure. For the abraded skin questionable to slight erythema was observed after 72 hours (3/5 animals). The evaluation of one animal was not possible due to substance-related staining. Scaling was observed in 4 animals after 8 days. No oedema was observed at the abraded skin sites. Because of the findings regarding the intact skin, the test substance is not considered irritating to the skin.

Eye irritation

For the determination of the eye irritation potential, three studies were evaluated in a weight of evidence approach.

The first study was performed according to Federal Register 38, No. 187, § 1500.42 (Draize test). 100 mg of the undiluted test substance were instilled in the conjunctival sac of six rabbits. The eyes were not washed. Animals were observed for 8 days.

Cornea opacity, iritis and chemosis were observed in none of the 6 animals. Conjunctivae redness was slight but not completely reversible within 72 h in 2/6 animals, where the study was terminated.

Another study was performed with the product and similar to US EPA Federal Register 43, No. 163, §163.81-5 (TSCATS, 1987; CIBA GEIGY, 1982). The eyes of three New Zealand White rabbits were treated with 100 mg test substance and left unwashed. No signs of eye irritation were observed within 8 days in any of the tested animals.

The third test followed the recommendations of Draize et al. (1944); Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes; Jour. Pharma. and Exptl. Therap. 82, 377 (TSCATS, 1987; Rosner Labs, 1963). Approximately 10 mg of finely ground test substance was instilled in the conjunctival sac of six albino rabbits. The eyes were not washed. Animals wer observed for 7 days. Coujunctival redness was observed in all animals immediately after treatment. It had resolved after 24 hours. No other signs of eye irritation were observed in any of the test animals.

Based on the available study data it is concluded that the test substance is not irritating to the eyes.


Justification for selection of skin irritation / corrosion endpoint:
Comparable to guideline study with acceptable restrictions

Justification for selection of eye irritation endpoint:
Endpoint was addressed by a WoE approach.

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 as irritating for skin or eyes under Directive 67/548/EEC.

                                             

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 irritation under Regulation (EC) No. 1272/2008.