Registration Dossier
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EC number: 222-429-4 | CAS number: 3468-63-1
- 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
Description of key information
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Other substances present in the test material might have contributed to the observed effects
- Qualifier:
- equivalent or similar to
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
- GLP compliance:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- 32 days
- Frequency of treatment:
- daily in diet
- Remarks:
- Doses / Concentrations:
0.2% (w/w) = 2,000ppm
Basis:
nominal in diet - Remarks:
- Doses / Concentrations:
1.0% (w/w) = 10,000 ppm
Basis:
nominal in diet - Remarks:
- Doses / Concentrations:
2.5% (w/w) = 25,000ppm
Basis:
nominal in diet - No. of animals per sex per dose:
- 10
- Control animals:
- yes, plain diet
- Dose descriptor:
- NOAEL
- Effect level:
- <= 10 000 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Overall behavior and body weight
- Dose descriptor:
- NOAEL
- Effect level:
- < 2 000 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Changes in blood samples
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
- Critical effects observed:
- not specified
- Executive summary:
Ten male and ten female SPF-Wistar rats per group were exposed to C.I. Pigment Orange 5 in the diet for 32 days at three concentrations of 2.5%, 1% and 0.2%.
At the highest test concentration (2.5%) 7 male and 3 female rats died with the signs of severe weight loss. The general behavior of rats at 1 and 0.2% was not affected. The body weight gain was linked with a dose-dependence to the test substance. Only female rats at 0.2% concentration of test substance in the diet was not affected.
Tests of blood samples showed lower hemoglobin level, decrease in erythrocyte and leukocyte increase at all three test concentrations compared with the control group. The urine examination revealed no pathological findings.
The histological examination of the organs did not show any clear signs of changes related to the experiment. Only the iron content in the spleen appears to be slightly elevated in all experimental groups compared to the control group. The effect was not dose related.
Infiltrates of lymphocytes in liver and kidney are to be interpreted as non-specific response to unspecified identifiable stimulus and was not dose related.
The macroscopic and microscopic examination of the organs of the rats showed a remarkable weight loss of the animals at the highest test exposure concentration (2.5%) and a small increase of the iron content in the spleen of all animals.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
0.2% Lowest LOAEC in feed study with rats (estimated daily dose: 100 mg/kg b.w.)
Repeated dose toxicity: via oral route - systemic effects (target organ) cardiovascular / hematological: spleen
Justification for classification or non-classification
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