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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
