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EC number: 214-353-5 | CAS number: 1122-58-3
- 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
- Study period:
- Apr 16-1992 to June 19-1992.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study by GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: US Consumer Protection Safety Commission
- Principles of method if other than guideline:
- US Consumer Protection Safety Commission 21CFR1500 Guideline, using the Draize Scale
- GLP compliance:
- yes
Test material
- Reference substance name:
- N,N-dimethylpyridin-4-amine
- EC Number:
- 214-353-5
- EC Name:
- N,N-dimethylpyridin-4-amine
- Cas Number:
- 1122-58-3
- Molecular formula:
- C7H10N2
- IUPAC Name:
- N,N-dimethylpyridin-4-amine
- Test material form:
- other: Solid
- Details on test material:
- - Name of test material: 4-Dimethylaminopyridine
- Physical state: White or off white solid
- Lot/batch No.: 20315AB
- Stability under test conditions: Stable under test conditions
- Storage condition of test material: Room temperature
- Other: Solubility: 7.6 g in 100 ml H2O at 25°C
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animals were purchased from a registered commercial breeding laboratory (Eastern Rabbit Breeding Laboratories, Taunton, MA).
- Age at study initiation: 10 to 12 weeks
- Weight at study initiation: between 2.0 and 3.0 kilograms
- Housing: Animals were individually housed using suspended stainless steel cages. Hardwood chips (Sani-chips , J.P. Murphy Forest Products, Montvale, NJ) were used as non-contact bedding under the cages. The laboratory and animal rooms were maintained as limited access facilities.
- Diet (e.g. ad libitum): controlled diet of a commercial rabbit ration
- Water (e.g. ad libitum): ad libitum
- Acclimation period: The animals were placed in quarantine for a period of 4 days under the same conditions as for the actual test.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.2 °C i.e. 68+3°F
- Humidity (%): 30-70%
- Air changes (per hr): a minimum of 10 to 13 complete air exchanges per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle using full spectrum fluorescent lights.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Skin was clipped; tested in intact skin and abraded skin on each animal.
- Vehicle:
- physiological saline
- Controls:
- other: Test substance was applied to one intact and one abraded site per animal. Seperate animals were not required. Each animal served as its own control.
- Amount / concentration applied:
- 0.5 gram, moistened with 0.5 ml of USP Saline
- Duration of treatment / exposure:
- Four hours. The patches were applied to one intact site and one abraded site per animal. The test substance was kept in contact with the skin for 4 hours. The skin was wiped following the 4 hour exposure period to remove remaining test substance.
- Observation period:
- Animals were observed for signs of erythema and edema at 24 and 72 hours post application of the test substance. Observations were scored according to the "Draize Scale for Scoring Skin Reactions"
- Number of animals:
- Six, three male and three female.
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: Material was held in place with an impervious bandage (Vetrap, 3M, St.Paul, MN)
REMOVAL OF TEST SUBSTANCE
- Washing: No washing but the skin was wiped following the 4 hour exposure period to remove remaining test substance.
- Time after start of exposure: Four hours
SCORING SYSTEM: A Primary Irritation score was obtained by adding the mean values for erythema and eschar formation at 24 hours and 72 hours for intact
skin to the mean values for abraded skin at 24 and 72 hours (four values). Similarly, the mean values for edema formation at 24 hours and at 72 hours for
intact skin were added to the mean values for abraded skin (four values). The total of the eight values were divided by four to give the Primary Irritation Index.
A test substnce with a PII of 0 was considered a non-irritant. A test substance with an index of 2 or less was considered a mild irritant. Test substances with indices greater than 2 and less than 5 were moderate irritants. Any test substances with an index of 5 or more were considered severe irritants. Those substances that destroy the structure of the intact skin or change it irreversibly were considered corrosive.
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- >= 5
- Max. score:
- 5
- Reversibility:
- not reversible
- Remarks on result:
- other: All six animals died after 4 hrs. PDII (Test) = Necrosis. PDII (Control) = 0.0
- Irritant / corrosive response data:
- All animals died during the 4 hour application period. Blood was observed around the nose and mouth, and the position of the animals indicated
convulsions prior to death. - Other effects:
- The gross necropsy indicated signs of hemorrhaging in the lungs and pericardial sac; and the blood had a dark blue color.
Any other information on results incl. tables
Severe necrosis was observed in all rabbits at all test sites, indicating corrosive damage to the skin. None of the control sites of any animal showed signs of erythema or edema, whether the skin was abraded or intact.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Necrosis and death in all the test animals Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is considered a corrosive irritant.
- Executive summary:
4-Dimethylaminopyridine was tested in a dermal irritation study according to the U.S. 16 CFR 1500.41 method, under GLP, in New Zealand white rabbits. The material (0.5 g, moistened with saline) was applied to the clipped intact and abraded skin and held in place under occlusive dressing for four hours. All 6 animals died during the test period. No scores of erythema or edema were recorded for he four animals; severe necrosis was observed at all test sites after 4 hours of application indicating corrosive damage to the skin. The material is considered a corrosive irritant.
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