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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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 review article or handbook
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:
- Skin sensitization study of Niacinamide (CAS no: 98-92-0) was conducted in 10 guinea pigs to determine its sensitization potential.
- GLP compliance:
- not specified
- Type of study:
- not specified
- Justification for non-LLNA method:
- No Data Available
Test material
- Reference substance name:
- Niacinamide
- IUPAC Name:
- Niacinamide
- 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
- Remarks:
- migrated information: 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
Constituent 2
- 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)
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- not specified
- Concentration / amount:
- Induction concentration: 0.1 mL at 2.5 X 5% (ICC i.e.,12.5%)
- Day(s)/duration:
- 14 days
- Adequacy of induction:
- not specified
Challengeopen allclose all
- No.:
- #1
- Route:
- intradermal and epicutaneous
- Vehicle:
- not specified
- Concentration / amount:
- (A1)Challenge concentration: 0.1 mL at 5% (ICC) and 20% (ACC): 10 guinea pigs
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- intradermal and epicutaneous
- Vehicle:
- not specified
- Concentration / amount:
- (B1)Rechallenge concentration: 0.1 mL at 5% (ICC) and 20% (ACC)
- Adequacy of challenge:
- not specified
- No.:
- #3
- Route:
- intradermal and epicutaneous
- Vehicle:
- not specified
- Concentration / amount:
- (B2) Confirmatory challenge : 0.1 mL at 5% (ICC) and 20% (ACC)
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 18 guinea pigs
8: preliminary skin irritation test
10: skin sensitization test - Details on study design:
- MAIN STUDY
INDUCTION EXPOSURE: Intradermal
- No. of exposures:4
- Exposure period: No Data Available
- Test groups:10 guinea pigs
- Control group: No Data Available
- Site: 4 sites, 2 auxillary and 2 inguinal lymph nodes
- Frequency of applications:1
- Duration: No Data Available
- Concentrations: 0.1 mL at 2.5 X 5% (ICC)
(A1).CHALLENGE EXPOSURE: Intradermal and Epicutaneous
- No. of exposures:1
- Day(s) of challenge: Fourteen days later, challenge test was performed
- Exposure period:24 hours
- Test groups:10guinea pigs
- Control group: No Data Available
- Site: onto the shaved flank in a small circular area
- Concentrations: 0.1 mL at 5% (ICC) and 20% (ACC).
- Evaluation (hr after challenge):24 hours
(B1). RECHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: 2 weeks Later, rechalleange test was performed.
- Exposure period: No Data Available
- Test groups:10 animal
- Control group: 4 animal (same sex)
- Site: Intradermally and topically on opposite flanks
- Concentrations: 0.1 mL at 5% (ICC) and 20% (ACC).
- Evaluation (hr after challenge): No Data Available
(B2) Confirmatory challenge:
- No. of exposures:1
- Day(s) of challenge: 1 weeks Later, test was Confirmatory challenge performed.
- Exposure period: No Data Available
- Test groups:10 animal
- Control group: 4 animal (same sex)
- Site: Intradermally and topically on opposite flanks
- Concentrations: 0.1 mL at 5% (ICC) and 20% (ACC).
- Evaluation (hr after challenge): No Data Available - Challenge controls:
- 4 animal (same sex):Rechallenge Test and Confirmatory challenge
Study design: in vivo (LLNA)
- Statistics:
Each injection reaction was given a total score based on size (2 largest diameters), erythema and oedema. Individual reactions were considered positive when their total score was significantly greater than the average total score for control reactions. Application reactions were scored on a 0 to +++ scale.and individual reactions were considered positive if they were + or greater and there were no erythema reactions in controls.Reactions were examined under a constant and artificial day light.
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 168
- Group:
- test chemical
- Dose level:
- 0.1 mL at 5% (ICC) and 20% (ACC).
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Negative skin effects were observed in treated animals.
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- Negative skin effects were observed in treated animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- The test material Niacinamide (CAS no: 98-92-0) was considered to be not sensitizing on skin of guinea pigs.
- Executive summary:
Skin sensitization study of Niacinamide (CAS no: 98-92-0) was conducted in guinea pigs to determine its sensitization potential.
The preliminary irritation tests were performed in 8 guinea pigs to determine concentrations suitable for sensitization test [injection challenge concentration (ICC) and application challenge concentration(ACC)]. The concentration giving slight but perceptible irritation with no oedema was selected as the injection challenge concentration (ICC) and the highest concentration which caused no irritation was selected as the application challenge concentration ( ACC).
As a result of the preliminary studies, the concentration selected for skin sensitization test were 5% forICC and 20% for ACC.
During the induction phase,the total dose was administered on one occasion as 4 intradermal injections, each 2.5 times the ICC (2.5X5%). Fourteen days later each animal was challenged intradermally in one flank and topically in the other with 0.1 ml aliquots of test substance at the respective ICC and ACC (5%and 20% respectively). Twenty-four hours later the reactions were observed.Reactions were examined under a constant and artificial day light.
In the absence of sensitization reactions at first challenge the induction and challenge procedures were repeated, andapparent sensitization reactions confirmed 7 days later by a second and confirmatory challenge with controls included.
At 24 hours after the first challenge(A1)and at the second(B1)and confirmatory challenge(B2)with 5% and 20% niacinamide none of the rabbits showed positive results. Thus, it can be concluded that theNiacinamide(CAS No: -98-92-0)was considered to be not sensitizing onguinea pigs.
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