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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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: According to EFSA Scientific Committee on Food - Scientific Panel on Dietetic Products, Nutrition and Allergies (2006) Tolerable Upper Intake Levels for Vitamins and Minerals, see section "exposure related to observations in humans" for details.
- Overall assessment factor (AF):
- 3
- Modified dose descriptor starting point:
- other: 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 for intraspecies differences.
- Value:
- 1.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Body weight (worker) 70 kg, respiratory volume (8 h, light activity) 10.00 m3/person, absorption oral/inhalation factor 0.5
- AF for dose response relationship:
- 1
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
- AF for differences in duration of exposure:
- 1
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
- AF for other interspecies differences:
- 1
- Justification:
- The uncertainty factor of 3 allows for the fact that a slight effect was reported and only a small number of subjects was used, but takes into account the observed dose-response relationship.
- AF for intraspecies differences:
- 3
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
- AF for the quality of the whole database:
- 1
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
- AF for remaining uncertainties:
- 1
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.14 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: According to EFSA Scientific Committee on Food - Scientific Panel on Dietetic Products, Nutrition and Allergies (2006) Tolerable Upper Intake Levels for Vitamins and Minerals, see section "exposure related to observations in humans" for details.
- Overall assessment factor (AF):
- 3
- Modified dose descriptor starting point:
- other: 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 for intraspecies differences.
- Value:
- 0.43 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Body weight (worker) 70 kg, 100 % dermal absorption
- AF for dose response relationship:
- 1
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
- AF for differences in duration of exposure:
- 1
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
- AF for other interspecies differences:
- 1
- Justification:
- The uncertainty factor of 3 allows for the fact that a slight effect was reported and only a small number of subjects was used, but takes into account the observed dose-response relationship.
- AF for intraspecies differences:
- 3
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
- AF for the quality of the whole database:
- 1
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
- AF for remaining uncertainties:
- 1
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Derived DNELs are based on results obtained in human studies (see IUCLID section "exposure related to observations in humans" for details). The limiting adverse effect at lower doses is flushing, and this has been reported at much lower intakes than other possible adverse effects. The most severe and potentially life-threatening adverse effects, such as hepatotoxicity, occur at doses one order of magnitude higher than have been reported for flushing. The dose of free nicotinic acid reported to produce flushing consistently in clinical studies is 50 mg/day (Sebrell and Butler, 1938; Spies et al., 1938). The available data indicate that flushing would be unlikely to occur repeatedly in subjects given less than 50 mg/day, but occasional flushing was reported by Sebrell and Butler (1938) at a dose of 30 mg of nicotinic acid daily. A 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 hypercholesterolaemia (3000 mg/day) and which is associated with a high incidence of serious adverse reactions.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.25 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: According to EFSA Scientific Committee on Food - Scientific Panel on Dietetic Products, Nutrition and Allergies (2006) Tolerable Upper Intake Levels for Vitamins and Minerals, see section "exposure related to observations in humans" for details.
- Overall assessment factor (AF):
- 3
- Modified dose descriptor starting point:
- other: 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 for intraspecies differences.
- Value:
- 0.75 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Body weight (general public) 70 kg, respiratory volume (24 h, basal activity) 20.00 m3/person, absorption oral/inhalation factor 0.5
- AF for dose response relationship:
- 1
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
- AF for differences in duration of exposure:
- 1
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
- AF for other interspecies differences:
- 1
- Justification:
- The uncertainty factor of 3 allows for the fact that a slight effect was reported and only a small number of subjects was used, but takes into account the observed dose-response relationship.
- AF for intraspecies differences:
- 3
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
- AF for the quality of the whole database:
- 1
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
- AF for remaining uncertainties:
- 1
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.14 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: According to EFSA Scientific Committee on Food - Scientific Panel on Dietetic Products, Nutrition and Allergies (2006) Tolerable Upper Intake Levels for Vitamins and Minerals, see section "exposure related to observations in humans" for details.
- Overall assessment factor (AF):
- 3
- Modified dose descriptor starting point:
- other: 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 for intraspecies differences.
- Value:
- 0.43 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Body weight (general public) 70 kg, 100 % dermal absorption
- AF for dose response relationship:
- 1
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
- AF for differences in duration of exposure:
- 1
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
- AF for other interspecies differences:
- 1
- Justification:
- The uncertainty factor of 3 allows for the fact that a slight effect was reported and only a small number of subjects was used, but takes into account the observed dose-response relationship.
- AF for intraspecies differences:
- 3
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
- AF for the quality of the whole database:
- 1
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
- AF for remaining uncertainties:
- 1
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.14 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: According to EFSA Scientific Committee on Food - Scientific Panel on Dietetic Products, Nutrition and Allergies (2006) Tolerable Upper Intake Levels for Vitamins and Minerals, see section "exposure related to observations in humans" for details.
- Overall assessment factor (AF):
- 3
- Modified dose descriptor starting point:
- other: 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 for intraspecies differences.
- Value:
- 0.43 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Body weight (general public) 70 kg
- AF for dose response relationship:
- 1
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
- AF for differences in duration of exposure:
- 1
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
- AF for other interspecies differences:
- 1
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
- AF for intraspecies differences:
- 3
- Justification:
- The uncertainty factor of 3 allows for the fact that a slight effect was reported and only a small number of subjects was used, but takes into account the observed dose-response relationship.
- AF for the quality of the whole database:
- 1
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
- AF for remaining uncertainties:
- 1
- Justification:
- See section on exposure related to observations in humans for details, EFSA (2006)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
Derived DNELs are based on results obtained in human studies (see IUCLID section "exposure related to observations in humans" for details). The limiting adverse effect at lower doses is flushing, and this has been reported at much lower intakes than other possible adverse effects. The most severe and potentially life-threatening adverse effects, such as hepatotoxicity, occur at doses one order of magnitude higher than have been reported for flushing. The dose of free nicotinic acid reported to produce flushing consistently in clinical studies is 50 mg/day (Sebrell and Butler, 1938; Spies et al., 1938). The available data indicate that flushing would be unlikely to occur repeatedly in subjects given less than 50 mg/day, but occasional flushing was reported by Sebrell and Butler (1938) at a dose of 30 mg of nicotinic acid daily. A 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 hypercholesterolaemia (3000 mg/day) and which is associated with a high incidence of serious adverse reactions.
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.
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