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Diss Factsheets
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EC number: 274-700-1 | CAS number: 70616-89-6
- 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
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- other: assessment from available information
- Adequacy of study:
- key study
- Study period:
- 2017 - 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- assessment from available information
- GLP compliance:
- no
- Radiolabelling:
- no
- Conclusions:
- According to current valid guidance the test substance with the result of LD50 in acute oral test higher than 2000 mg/kg is considered as non-toxic after single oral application. Reactive Orange 13 did not penetrate into the organism through the skin after single application.The test substance is considered to be non-irritating to the eye and skin of rabbit. The test substance elicited negative sensitising response in guinea pig.Any adverse effect on the health of animals after acute inhalation test showed that the test substance did not evoke systemic toxicity of organism after inhalation.According to results of acute exposition of the test substance Reactive Orange 13 the test substance did not penetrate through the respiratory tract, skin and digestive tract.After repeated oral administration of the test substance Reactive Orange 13 morphological alterations in the kidneys, gastrointestinal tract and lymph nodes were noted. Microscopically, an increased storage of hyaline bodies in the stomach of both sexes and kidneys of males was recorded with increasing dose. The findings in the kidneys persisted to the end of recovery period. After repeated oral administration the test substance is absorbed through the blood circulation and systemic effect occurs. Target organ of systemic toxicity seems to be kidneys.Results recorded during the reproduction part of Reproduction/Developmental Toxicity Screening Test and Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test with repeated oral administration showed that the test substance did not influenced reproduction parameters of males and females. Development of pups was not influenced by the test substance administration. After repeated oral administration the test substance did not penetrate into the testes and through the placental barrier.No data about metabolism and excretion of the test substance were found.
Reference
Description of key information
According to current valid guidance the test substance with the result of LD50 in acute oral test higher than 2000 mg/kg is considered as non-toxic after single oral application.
Reactive Orange 13 did not penetrate into the organism through the skin after single application.
The test substance is considered to be non-irritating to the eye and skin of rabbit.
The test substance elicited negative sensitising response in guinea pig.
Any adverse effect on the health of animals after acute inhalation test showed that the test substance did not evoke systemic toxicity of organism after inhalation.
According to results of acute exposition of the test substance Reactive Orange 13 the test substance did not penetrate through the respiratory tract, skin and digestive tract.
After repeated oral administration of the test substance Reactive Orange 13 morphological alterations in the kidneys, gastrointestinal tract and lymph nodes were noted. Microscopically, an increased storage of hyaline bodies in the stomach of both sexes and kidneys of males was recorded with increasing dose. The findings in the kidneys persisted to the end of recovery period.
After repeated oral administration the test substance is absorbed through the blood circulation and systemic effect occurs. Target organ of systemic toxicity seems to be kidneys.
Results recorded during the reproduction part of Reproduction/Developmental Toxicity Screening Test and Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test with repeated oral administration showed that the test substance did not influenced reproduction parameters of males and females. Development of pups was not influenced by the test substance administration.
After repeated oral administration the test substance did not penetrate into the testes and through the placental barrier.
No data about metabolism and excretion of the test substance were found.
Key value for chemical safety assessment
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.