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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Endpoint summary

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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
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