Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information
Short description of key information:
Reproductive toxicity - fertility - oral/dermal/inhalation: Study was waived; substance is not classified for this endpoint. The substance is considered not to exert any reproductive toxic effects (fertility).

Reproductive toxicity - fertility:
Reproduction: Non-human information: This information is not available.
Developmental toxicity / teratogenicity: Non-human information: This information is not available.

Effects on developmental toxicity

Description of key information
Reproductive toxicity - developmental toxicity / teratogenicity - oral/dermal/inhalation: Study was waived; substance is not classified for this endpoint. The substance is considered not to exert any reproductive toxic effects (developmental toxicity).
Reproductive toxicity - developmental toxicity / teratogenicity:
Reproduction: Non-human information: This information is not available.
Developmental toxicity / teratogenicity: Non-human information: This information is not available.

Justification for classification or non-classification

It can reasonably be deduced that Pigment Red 112 does not cause toxicity to reproduction 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 is a chemically unreactive substance,

- Pigment Red 112 can be considered insoluble because it has an extremely low solubility in water and n-octanol,

- due to its extremely low solubility, it is unlikely that Pigment Red 112 becomes systemically bioavailable after oral, dermal or inhalation exposure,

- Pigment Red 112 caused no systemic toxic effects in a 28-day oral gavage study in rats (NOAEL 1000 mg/kg/day) and there was no evidence of absorption of the substance,

- Pigment Red 112 does not have to be classified as skin sensitizing (referring to the pigment as such, notwithstanding possible effects of impurities) or as skin or eye irritating, indicating that its chemical inertness and extremely low solubility in water and n-octanol largely prevent interaction with living cells and tissues.

It can therefore be concluded with sufficient certainty that Pigment Red 112 will not cause toxicity to reproduction and that testing is not scientifically necessary.

 

 

It can reasonably be deduced that Pigment Red 112 does not cause developmental toxicity (including effects on breast-fed babies via the mother's milk) 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 is a chemically unreactive substance,

- Pigment Red 112 can be considered insoluble because it has an extremely low solubility in water and n-octanol,

- due to its extremely low solubility, it is unlikely that Pigment Red 112 becomes systemically bioavailable or enters the mother's milk after oral, dermal or inhalation exposure,

- Pigment Red 112 caused no systemic toxic effects in a 28-day oral gavage study in rats (NOAEL 1000 mg/kg/day) and there was no evidence of absorption of the substance,

- Pigment Red 112 does not have to be classified as skin sensitizing (referring to the pigment as such, notwithstanding possible effects of impurities) or as skin or eye irritating, indicating that its chemical inertness and extremely low solubility in water and n-octanol largely prevent interaction with living cells and tissues.

It can therefore be concluded with sufficient certainty that Pigment Red 112 will not cause developmental toxicity and that testing is not scientifically necessary.