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Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Guideline compliant study.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
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.

Key study

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.


Short description of key information:
Data for C.I. Pigment Green 50 are not available. Read across was performed to a study conducted with C.I. Pigment Yellow 53. In the combined repeated dose and reproductive/ developmental toxicity screening test according to OECD guideline 422 no reproductive toxicity was observed.

Justification for selection of Effect on fertility via oral route:
Guideline compliant study.

Effects on developmental toxicity

Description of key information
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.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Guideline compliant study.
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
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.

Key study

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.

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.


Justification for selection of Effect on developmental toxicity: via oral route:
Guideline compliant study.

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 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.