Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 223-754-4 | CAS number: 4051-63-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

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
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Valid
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Pigment Red 177 was administered orally by gavage to groups of 10 male and 10 female Wistar rats (F0 animals) at dose levels of 100, 300 and 1000 mg/kg bw/d. The study followed OECD testing guideline 422 and GLP (BASF 2013). The test substance was suspended in water as it is not soluble in any vehicle.
Regarding clinical examinations,signs of general systemic toxicity were not observed in male and female parental animals of test groups 1-3 (100, 300 and 1000 mg/kg bw/d) during the entire study period. Female animal No. 138 of test group 3 (1000 mg/kg bw/d) showed clinical findings during lactation and did not properly nurse its pups on postnatal day (PND) 0 and 1. Taking into account that the litter size of 17 pups was very high for this rat strain, giving birth to this high amount of pups was considered to have been exhausting and stressful for the animal. The resulting impaired clinical condition of the animal during lactation was assessed to have been influenced the nursery and, given that, led to the increased pup mortality. In addition, the increased occurrence of runts on PND 1 was assumed as being related to the litter size which has been proven to have an impact on the development status of pups (Romero et al., 1992). Therefore, the occurrence of the mentioned findings in the single animal was not assessed as being related to treatment. Fertility indices for male and female animals were not impaired by test-substance administration even at a dose level of 1000 mg/kg bw/d. In addition, live birth indices of pups in all test groups were not influenced.
Concerning clinical pathology no treatment-related, adverse effects were observed up to a dose of the compound of 1000 mg/kg bw/d. Regarding pathology, there were no treatment-related organ weight changes. Histopathology revealed the presence of the test substance in the lumen of the gastrointestinal tract in form of red particles or crystals. This correlated with the red discoloration of the contents observed macroscopically. This finding did not cause any tissue alterations and therefore it was considered to be treatment-related but not adverse.
As discussed in the toxicokinetics section, the pigment is considered to be not taken up by the body by the oral route.
Short description of key information:
No adverse effects on fertility were observed in a screening study in rats (OECD 422, BASF 2013). The highest tested dose was 1000 mg/kg bw.
Justification for selection of Effect on fertility via oral route:
key study
Effects on developmental toxicity
Description of key information
No adverse findings on offspring were observed in a screening study for developmental toxicity in rats with doses of up to 100, 300 and 1000 mg/kg bw (OECD 422, GLP) (BASF 2013).
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The study is discussed in the section for fertility and repeated dose toxicity.
The viability index as indicator for pup mortality was not impaired by test-substance administration at a dose level of 1000 mg/kg bw/d. The postimplantation loss was comparable for all dose groups. No adverse effects on offspring were observed.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available screening study is considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for fertility or developmental toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EG.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available screening study is reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for fertility or developmental toxicity under Regulation (EC) No. 1272/2008, as amended for the third time in Directive (EC 618/2012).
During the four days covered in the screening study, no effects via lactation were observed.
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.

Route: .live1