Registration Dossier
Registration Dossier
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EC number: 220-562-2 | CAS number: 2814-77-9
Endpoint summary
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.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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