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Diss Factsheets
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EC number: 206-735-5 | CAS number: 371-40-4
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- RTECS Number: BY1575000
- Year:
- 2 012
- Bibliographic source:
- RTECS (Registry of Toxic Effects of Chemical Substances):- Journal of Toxicologic Pathology. (Nihon Dokusei Byori Gakkai, editor, 3-25-8 Nishi- shinbashi, Minato-ku, Tokyo 105, Japan) V.1- 1988 Volume(issue)/page/year: 29,187,2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Low-Volume Eye Test: Ten μL of parafluoroaniline (PF) was directly applied to the cornea of the right eye of each rabbit. Eyes and eyelids were macroscopically scored for signs of irritation beginning 3 hours after dosing and periodically until recovery or 35 days. Tissues were obtained for light microscopic examination after 3 hours and on days 1, 3, and 35.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 4-fluoroaniline
- EC Number:
- 206-735-5
- EC Name:
- 4-fluoroaniline
- Cas Number:
- 371-40-4
- Molecular formula:
- C6H6FN
- IUPAC Name:
- 4-fluoroaniline
- Details on test material:
- - Name of test material: 4-fluoroaniline
- Molecular formula: C6H6FN
- Molecular weight: 111.12
- Substance type: Organic
- Physical state: Liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 10 µL
- Duration of treatment / exposure:
- the animals were treated once and eyes were examined macroscopically and scored for irritation at 3 hours and 1, 3, 7, and 35 days.
- Observation period (in vivo):
- 35 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Eyes were macroscopically examined with the aid of a penlight before dosing to insure absence of ocular abnormalities. Ten µL of an irritant was taken up in a 100 µL Teflon tipped Hamilton syringe (Hamilton Co, Reno, NV) and excess test substance was removed from the exterior of the syringe. The eyelids were then gently held open and 10 µL was placed directly above the center of the cornea of the right eye. Eyelids were released immediately after instillation without forced blinking or manipulation.
Eyes and eyelids were macroscopically scored for signs of irritation beginning 3 hours after dosing and periodically until recovery or 35 days. Tissues were obtained for light microscopic examination after 3 hours and on days 1, 3, and 35.
In vivo Confocal Microscopy assessment of the corneas was performed after each macroscopic examination and separately at 14 days. After evaluation at 35 days, the animals were euthanatized.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- by Light microscopy
- Time point:
- other: 3 hr
- Score:
- 53.5
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: Moderate to severe irritation; Days to recovery >35 days
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- In vivo CM and Live–Dead Assay
- Time point:
- other: 3 hr
- Score:
- 53.4
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: Moderate to severe irritation; Days to recovery >35 days
- Irritation parameter:
- maximum mean total score (MMTS)
- Remarks:
- Conventional MAS: Maximum Average Score
- Basis:
- mean
- Time point:
- other: observation periods beginning at day 1.
- Score:
- 80
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 35 days
- Remarks on result:
- other: Moderate to severe irritation; Days to recovery >35 days
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- 10 µL of 4-fluoroaniline instilled into rabbit eye caused moderate irritation as evaluated by a Low-Volume Eye Test
- Executive summary:
Low-Volume Eye Test was conducted to determine theon the extent of initial injury caused by 4 -fluoroaniline.Ten μl of parafluoroaniline (PF) was directly applied to the cornea of the right eye of each rabbit. Eyes and eyelids were macroscopically scored for signs of irritation beginning 3 hours after dosing and periodically until recovery or 35 days.Tissues were obtained for light microscopic examination after 3 hours and on days 1, 3, and 35. Initial corneal injury was characterized quantitatively at 3 hours and 1 day using in vivo confocal microscopy (CM) and by postmortem quantitation of dead corneal epithelial cells and keratocytes using a Live—Dead Assay (L/D, Molecular Probes) and scanning laser CM. Corneal changes over time were characterized quantitatively using in vivo CM performed at 3 hours and 1, 3, 7, 14, and 35 days.
Changes with parafluoroaniline were consistent with moderate to severe irritation.Specifically,corneal injury by parafluoroaniline tended to involve the epithelium and anterior stroma, with the mean normalized depth of injury (NDI) being 10.4% to 23.8%. The results can be summarised as:
- Overall irritation score by light microscopy ranged between 53.5 - 110 after 3 hours.
- Overall irritation score calculated as a mean of in-vivo Cm and live-dead assay ranged between 53.4 - 110 after 3 hours.
- Maximum Mean Total Score (MMTS) ranged between 80 - 110 after 24 hours. tal Score (MMTS) rangd between 80 - 110 after 24 hours.
- All the irritation effects were not fully reversible within 35 days.
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