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EC number: 202-718-1 | CAS number: 98-97-5
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- Final report of the safety assessment of niacinamide and niacin.
- Author:
- Cosmetic Ingredients Review (CIR)
- Year:
- 2 005
- Bibliographic source:
- International Journal of Toxicology 24 (Suppl 5): 1-31 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Preliminary irritation tests of Niacinamide were performed in guinea pigs to determine the concentration for suitable the sensitization study.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Nicotinamide
- EC Number:
- 202-713-4
- EC Name:
- Nicotinamide
- Cas Number:
- 98-92-0
- Molecular formula:
- C6H6N2O
- IUPAC Name:
- nicotinamide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Niacinamide
- Molecular formula: C6H6N2O
- Molecular weight: 122.1264 g/mol
- Substance type: Organic
- Physical state:Solid (powder)
-Smiles: c1cc(cnc1)C(=O)N
- InChI: 1S/C6H6N2O/c7-6(9)5-2-1-3-8-4-5/h1-4H,(H2,7,9)
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Niacinamide
- Molecular formula: C6H6N2O
- Molecular weight: 122.1264 g/mol
- Substance type: Organic
- Physical state:Solid (powder)
-Smiles: c1cc(cnc1)C(=O)N
- InChI: 1S/C6H6N2O/c7-6(9)5-2-1-3-8-4-5/h1-4H,(H2,7,9)
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- No data available
Test system
- Type of coverage:
- open
- Preparation of test site:
- clipped
- Vehicle:
- physiological saline
- Controls:
- not specified
- Amount / concentration applied:
- Intradermal application: 0.1ml
Dermal application: Amount- 0.1ml
concentration applied -5% ICC and 20%ACC - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24 hours
- Number of animals:
- Intradermal application: 8 (4/sex)
Dermal application: 4 - Details on study design:
- TEST SITE
- Area of exposure: small circular areas
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Intradermal application: erythema and edema
- Basis:
- mean
- Time point:
- 24 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Dermal application: erythema
- Basis:
- mean
- Time point:
- 24 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritation were observed.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- Niacinamide (CAS No: -98-92-0) was considered to be not-irritating on guinea pigs in the preliminary irritation tests performed for the sensitization study.
- Executive summary:
Preliminary irritation test was performed for Niacinamide(CAS No: -98-92-0) in guinea pigs to determine the concentration suitable for the sensitization study [injection challenge concentration (ICC) and application challenge concentration(ACC)].
In the preliminary test, the guinea pigs were treated intradermally and dermally.8 previously untreated guinea pigs were (4/SEX) were injected intradermally in the clipped and shaved flanks with 0.1ml aliquots of a range of concentration of test substance in physiological saline. 24 hours later, the skin was examined for erythema and edema.The concentration giving slight but perceptible irritation with no oedema was selected as the injection challenge concentration (ICC).
Aliquots of 0.1ml using a range of concentration of the test substance in distilled water were applied in small circular areas to the shaved flanks of 4 previously untreated guinea pigs.24 hours later, the skin was examined for erythema and the highest concentration which caused no irritation was selected as the application challenge concentration (ACC).
As a result of preliminary studies, the concentration of Niacinamide at which no irritation was observed were 5% for the ICC and 20% for ACC.
Since the test chemical did not induce any cutaneous effects at these concentrations, Niacinamide(CAS No: -98-92-0) was considered to be not irritating to the skin of guinea pigs.
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