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Diss Factsheets
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EC number: 200-441-0 | CAS number: 59-67-6
- 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
Description of key information
The weight of evidence analysis considered all relevant, adequate and reliable animal and human studies (EFSA, 2006). The human tolerable upper intake level for nicotinic acid was determined to be 10 mg/day or 0.14 mg/kg bw/day at 70 kg per person.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: oral
- Remarks:
- other: Weight of evidence approach
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Justification for data waiving:
- other:
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Assessment of all available, relevant, adequate and reliable animal and human data.
- GLP compliance:
- no
- Dose descriptor:
- NOAEL
- Effect level:
- 0.14 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: The human tolerable upper intake level for nicotinic acid was determined to be 10 mg/day or 0.14 mg/kg bw/day at 70 kg per person (EFSA, 2006).
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 0.14 mg/kg bw/day
- Study duration:
- chronic
- Species:
- other: human
- Quality of whole database:
- High - Compiled by the European Scientific Committee on Food, Scientific Panel on Dietetic Products, Nutrition and Allergies.
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
The key subacute animal study was carried out according to EU Method B.7 and OECD 407 (Repeated dose toxicity – oral). The objectives of the study were to determine the palatability and oral toxicity of test item in the rat following administration for 28 days. There was no effect of oral administration of test item in the diet at a dose level of 50 mg/kg/day for 28 days. At 250 and 1000 mg/kg/day there was a slight reduction in body weight gain and a slight increase in relative kidney weight. There was, however, no histopathologic evidence of systemic toxicity. The results obtained in the key study were confirmed in a supporting study.
According to REACH Annex VIII column 1 and 2 experimental studies with dosing via the inhalation and dermal route were waived. Further, the sub-chronic toxicity study requirement according to REACH Annex IX section 8.6.2 was waived based on a weight of evidence approach. Repeated dose toxicity was previously reviewed by the European Commission Scientific Committee on Food, the EFSA Panel on Additives and Products or Substances used in Animal Feed, the US FDA and the UK Food Standards Agency Expert Group on Vitamins and Minerals. An OECD SIDS review concluded that Nicotinic acid is essential for human and animal health. Based on all available information repeated exposure to nicotinic acid does not present a hazard to human health.
In addition to the animal studies presented repeated dose toxicity was assessed in a weight of evidence approach. All relevant, adequate and reliable data was reviewed by the European Commission Scientific Committee on Food, the EFSA Panel on Additives and Products or Substances used in Animal Feed, the US FDA and the UK Food Standards Agency Expert Group on Vitamins and Minerals. An OECD SIDS review concluded that Nicotinamide is essential for human and animal health and that based on the available information, the substance does not present a hazard to human health.
The European Food Safety Authority set a tolerable upper intake level for nicotinic acid. The tolerable upper intake level for nicotinic acid of 10 mg/day is based on the available data indicating occasional flushing at 30 mg per day, using an uncertainty factor of 3 to allow for the fact that a slight effect was reported, and that the study was performed in a small number of subjects, but taking into account the steep dose-response relationship. This upper level is 300-fold below the dose frequently used clinically for the treatment of hypercholesterolemia (3 g/day) and which is associated with a high incidence of serious adverse reactions.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The weight of evidence analysis considered all relevant, adequate and reliable animal and human studies (EFSA, 2006). The human tolerable upper intake level for nicotinic acid was determined to be 10 mg/day or 0.14 mg/kg bw/day at 70 kg per person.
Justification for classification or non-classification
Based on the data available the substance is not classified and labeled according to Regulation 1272/2008/EEC (CLP) and Directive 67/548/EEC (DSD).
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.