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EC number: 200-424-8 | CAS number: 59-42-7
- 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
Additional information
Source: National Toxicological Program, Technical Report Series No. 322. Toxicology and carcinogenesis studies of phenylephrine hydrochloride (CAS No. 61 -76 -7) in F344/N rats and B6C3F1 mice (feed studies).
In NTP studies, phenylephrine hydrochloride was not mutagenic in four tester strains of Salmonella typhimurium (TA100, TA1535, TA1537, and TA98) in the presence or absence of Aroclor 1254-induced male Sprague-Dawley rat or male Syrian hamster liver S9.
The results of mutagenicity studies of phenylephrine hydrochloride were equivocal in the mouse lymphoma L5178Y/TK+/- assay because a positive response, noted in the first trial without metabolic activation, occurred at high doses that were toxic to the cells (relative total growth of 12.2%) and was not reproduced in the second trial. Phenylephrine hydrochloride was not tested in the presence of S9 in the mouse lymphoma assay.
Phenylephrine hydrochloride induced sisterchromatid exchanges (SCEs) but not chromosomal aberrations in Chinese hamster ovary cells. The increase in SCEs was seen only in the absence of metabolic activation with Aroclor 1254- induced male Sprague-Dawley rat liver S9.
In an Micronucleus Test (study ID: A44702), phenylephrine hydrochloride was administered intraperitoneally 3 times to F344 rats. No indications were found for clastogenicity and aneugenicity.
In summary, phenylephrine hydrochloride was not mutagenic in bacteria with or without metabolic activation. The evidence for mutagenicity was equivocal in mammalian cells without metabolic activation at nearly toxic doses, and phenylephrine hydrochloride induced SCEs in mammalian cells in the absence of metabolic activation. Neither numerical nor structural chromosome damages were observed in an in vivo Micronucleus Test after intraperitoneal injection.
Short description of key information:
- AMES: negative
- Mouse lymphoma assay: positive in 1/2 experiments without S9 at cytotoxic concentrations.
- SCE Assay: positive only without S9
- CA in CHO cells: negativ
- MNT (ip) in mice: negative
Endpoint Conclusion:
Justification for classification or non-classification
The available data from secondary sources are not sufficient for classification and labelling of phenylephrine hydrochloride for mutagenicity.
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