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EC number: 207-987-9 | CAS number: 504-24-5
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- Deviations: Concerning: Provided Materials, study plan, p. 11
Study Plan:1x vial Methyl acetate, CAS No. 79-20-9 (positive control)
Reason:Methyl acetate was not provided with the kit. - Deviations:
- yes
- Remarks:
- This deviation did not influence the quality or integrity of the present study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-pyridylamine
- EC Number:
- 207-987-9
- EC Name:
- 4-pyridylamine
- Cas Number:
- 504-24-5
- Molecular formula:
- C5H6N2
- IUPAC Name:
- nickel
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- This test uses the three-dimensional RhCE EpiOcular™ (MatTek). It consists of normal, human-derived epidermal keratinocytes and mimics the histological, morphological, biochemical and physiological properties of the human corneal epithelium. The MatTek EpiOcular™ model has been widely used as a research and testing model for many years.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Approximately 50 mg (83.3 mg/cm2) of the test item were applied directly atop the EpiOcular™ tissue using an application spoon avoiding compression of the test item. The test item was spread to match size of the tissue.
- Duration of treatment / exposure:
- for 6 ± 0.25 h at 37 ± 1 °C, 5.0% CO2 / 95% air
- Duration of post- treatment incubation (in vitro):
- 18 ± 0.25
- Number of animals or in vitro replicates:
- 2
Results and discussion
In vitro
Results
- Irritation parameter:
- other: mean tissue viability [%]
- Run / experiment:
- mean
- Value:
- 1.7
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Value Cut off pass/fail
Mean Absolute OD570 nm NK 1.735 0.8 < NK < 2.5 pass
Mean Relative Viability PC [%] 28.4 < 50% pass
Max. Difference of % Viability [%] 1.5 < 20% pass
Any other information on results incl. tables
The potential of the test item to induce eye irritation was analysed by using the three-dimensional human corneal epithelium model EpiOcular, consisting of normal, human-derived epidermal keratinocytes mimicking characteristics of the corneal epithelium. In the present study 4-Aminopyridine was applied topically to the EpiOcularätissue for 6 h followed by 25 min post-soaking incubation after removal of the test item. After a 18 h post-treatment period cytotoxic effects were determined via MTT reduction assay. Ocular irritation potential of the test item was predicted from the relative mean tissue viabilities compared to the negative control tissues concurrently treated with aqua dest. The mixture of 50 mg test item per 1 mL MTT medium showed reduction of MTT as compared to the solvent. The test material turned blue/purple and the mixture turned purple/red. Sincethe mean relative tissue viability of the test item treated tissues (TM) was below the 60% threshold value no killed tissue controls were performed, since the test item has to be classified as irritant in any case. The mixture of 50 mg test item per 1 mL A. dest. and per 2 mL isopropanol showed no colouring as compared to the solvent. Therefore, NSCliving equalled 0%. The test item showed irritant effects. The mean relative tissue viability (% negative control) was ≤ 60% (1.7%). The controls confirmed the validity of the study. The mean absolute OD570of the two negative control tissues was> 0.8 and < 2.5 (1.735). The mean relative tissue viability (% negative control) of the positive control was < 50% (28.4%). The maximum inter tissue difference of replicate tissues of all dose groups was < 20% (1.5%).
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In this study under the given conditions the test item showed irritant effects. The test item is classified as “irritant“ in accordance with UN GHS “Category 1” or “Category 2”.
- Executive summary:
In the present study the eye irritating potential of 4-Aminopyridine was analysed. Since irritant substances are cytotoxic to the corneal epithelium after a short time exposure the cytotoxic effects of the test item on EpiOcular, a reconstituted three-dimensional human corneal epithelium model, were determined. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 6 h exposure period and 18 h post-treatment period and compared to those of the concurrent negative controls.
The mixture of 50 mg test item per 1 mL MTT medium showed reduction of MTT as compared to the solvent. The test material turned blue/purple and the mixture turned purple/red. Since the mean relative tissue viability of the test item treated tissues (TM) was below the 60% threshold value no killed tissue controls were performed, since the test item has to be classified as irritant in any case.
The mixture of 50 mg test item per 1 mL A. dest. and per 2 mL isopropanol showed no colouring as compared to the solvent.Therefore, NSClivingequalled 0%.
The test item showed irritant effects. The mean relative tissue viability (% negative control) was ≤ 60% (1.7%).
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