Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1979
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Nicotinic acid
- EC Number:
- 200-441-0
- EC Name:
- Nicotinic acid
- Cas Number:
- 59-67-6
- Molecular formula:
- C6H5NO2
- IUPAC Name:
- nicotinic acid
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material: Nicotinic acid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: Individual body weights were within the range 2.2 - 3.0 kg.
- Housing: The animals were caged individually in grid floor cages.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: The animals were acclimatised to the laboratory environment for a minimum of 7 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not controlled, but min. 14 °C
- Humidity (%): Not controlled
- Air changes: Fan controlled air circulation
- Photoperiod: natural lighting conditions supplemented with fluorescent lighting during the working hours (8.45 to 17.00)
IN-LIFE DATES: From: 09.1979 To: 09.1979
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g.
- The test article was moistened with water for administration. - Duration of treatment / exposure:
- Portions of the test article (0.5 g) were applied to one intact and one abraded site on each animal and covered with patches of gauze. Four hours after treatment the wrappings and collars were removed.
- Observation period:
- Immediately after removal of the wrappings the skin reactions on both the intact and abraded sites were scored. Following this initial reading the test sites were washed with warm water to prevent further exposure to the test article. The evaluation of the skin reactions was repeated 24, 48 and 72 hours after treatment.
- Number of animals:
- Six New Zealand White rabbits were used for the study.
- Details on study design:
- TEST SITE
- Area of exposure: 25 mm x 25 mm
- % coverage: 100
- Type of wrap if used: A small plug of cotton wool weighing approximately one g was placed over the top of the pads to achieve uniform pressure over the whole treated surface. The pads were held in place by a strip of adhesive impermeable plaster. An Elizabethan collar was placed around the neck of each animal to prevent removal of the wrapping.
REMOVAL OF TEST SUBSTANCE
- Washing: Yes, washed with warm water
- Time after start of exposure: 4 h
SCORING SYSTEM: U. S. Food and Drug Administration "Appraisal of the Safety Chemicals in Foods, Drugs and Cosmetics," 1959
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 4, 24, 48, 72
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 4, 24, 48, 72
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4, 24, 48, 72
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4, 24, 48, 72
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- A primary irritation index of 0.0 was obtained. The test article is therefore regarded as a non irritant. No skin reactions were noted in any of the animals during the observation period.
The test article did not produce a corrosive response as defined by the Code of Federal Regulations, Title 49, Part 173, 1976. No evidence of tissue destruction was noted during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A primary skin irritation and corrosivity study was performed in the albino rabbit on the test item. No skin irritation was noted in any of the six animals at any of the observations at 4, 24, 48 and 72 h. A primary irritation index of 0.0 was obtained. The test article was therefore regarded as a non-irritant. The test item did not produce a corrosive response as defined by the Code of Federal Regulations Title 49, Part 173, 1276.
- Executive summary:
A study similar or equivalent to EU Method B.4 and OECD Guideline 404 (Acute Dermal Irritation / Corrosion) was carried out. A group of six albino rabbits was treated with the test item (occlusive with 4 h exposure). No skin irritation was noted in any of the six animals at any of the observations at 4, 24, 48 and 72 h. A primary irritation index of 0.0 was obtained following observations at 4, 24, 48 and 72 h. The test article was therefore regarded as a non-irritant. The test item did not produce a corrosive response as defined by the Code of Federal Regulations Title 49, Part 173, 1276.
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.