Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Study duration:
subacute
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Toxicity to reproduction: other studies

Additional information

Effects on fertility

The following information is taken into account for any hazard / risk assessment:

Reproductive toxicity - fertility - oral/dermal/inhalation: Based on the data generated from in an OECD 421 reproduction / developmental toxicity screening test, the no observed adverse effect level (NOAEL) is established at 1000 mg/kg body weight for general toxicity and reproduction in parental animals and for developmental toxicity in the pups; substance is not classified for this endpoint. The substance is considered not to exert any reproductive toxic effects (fertility).

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

Developmental toxicity

The following information is taken into account for any hazard / risk assessment:

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 3 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 3 is a chemically unreactive substance,

- Pigment Red 3 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 3 becomes systemically bioavailable to a significant extent after oral, dermal or inhalation exposure,

- Pigment Red 3 caused no systemic toxic effects in an OECD 421 study in rats (NOAEL 1000 mg/kg/day) and there was no evidence of absorption of the substance. However systemic toxic effects have been seen in 2 year feed studies with high doses (up to 50,000 mg/kg in diet)

- Pigment Red 3 does not have to be classified as skin sensitizing 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 3 will not cause toxicity to reproduction and that testing is not scientifically necessary.

 

It can reasonably be deduced that Pigment Red 3 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 3 is a chemically unreactive substance,

- Pigment Red 3 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 3 becomes systemically bioavailable or enters the mother's milk after oral, dermal or inhalation exposure,

- Pigment Red 3 caused no systemic toxic effects in an OECD 421 study in rats (NOAEL 1000 mg/kg/day) and there was no evidence of absorption of the substance. However systemic toxic effects have been seen in 2 year feed studies with high doses (up to 50,000 mg/kg in diet)

- Pigment Red 3 does not have to be classified as skin sensitizing 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 3 will not cause developmental toxicity and that testing is not scientifically necessary.