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EC number: 269-047-4 | CAS number: 68186-85-6 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77377.
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.
In a combined repeated dose and reproductive/ developmental toxicity screening test according to OECD guideline 422 (MHLW, 2002), C.I. Pigment Yellow 53 was administered to groups of Sprague Dawley rats (12/sex) at concentrations of 0 (vehicle), 250, 500, 1000 mg/kg bw/d. Males were treated for 46 days and females from 14 days before mating to day 4 of lactation.
The treatment did have any effect on several reproductive parameters including number of pregnant females, number of corpora lutea and implantation sites, implantation index and delivery index, nursing index, gestation index, fertility index, copulation index, gestation length and estrous cycle. Thus, no effects were observed on reproductive performances in males and females given any of the doses. The NOAEL for reproduction is equal to or greater than 1000 mg/kg bw/d.
Data for C.I. Pigment Green 50 are not available. Read across was performed to studies conducted with C.I. Pigment Yellow 53. In the combined repeated dose and reproductive/ developmental toxicity screening test according to OECD guideline 422 no developmental toxicity was observed.
No external anomalies were observed during macroscopic examination. Live birth index and viability index were not altered by treatment. Sex ratio, number of pups alive on day 4 of lactation and body weight on day 0 and 4 post natal were comparable to control. Thus, no effects were observed on development of offspring at any of the doses. The NOAEL for development is equal to or greater than 1000 mg/kg bw/d.
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 reproductive toxicity under Directive 67 / 548 / EEC.
Classification, Labeling, 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 reproductive toxicity under Regulation (EC) No. 1272/2008.
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