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Diss Factsheets
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EC number: 203-168-5 | CAS number: 104-03-0
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented study according to international accepted guidelines and GLP compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-nitrophenylacetic acid
- EC Number:
- 203-168-5
- EC Name:
- 4-nitrophenylacetic acid
- Cas Number:
- 104-03-0
- Molecular formula:
- C8H7NO4
- IUPAC Name:
- 4-nitrophenylacetic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Test item 4-nitrophenyl-acetic acid
Batch No. 0046D93
Physical state solid, crystalline powder
Colour yellowish to yellow-brownish
Storage cool, dry place, protected from light
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Species and strain: New Zealand white rabbit
Source: S&K LAP Kft.
Hygienic level during the study: good conventional
Number of animal: 3 males
Age of animals: adult rabbits, 11 weeks old
Body weight range at the beginning of the study: 2338 - 2950 g
Body weight range at the end of the study: 3364 - 3780 g
Acclimatisation time: 5 days in first animal, 6 days in second animal and 7 days in third animal
Animal health: Only animals in acceptable health condition were used for the test.
Housing: Animals were housed individually in metal cage.
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 20 ± 3 °C
Relative humidity: 30-70 %
Ventilation: 10-15 air exchanges/hour by central air-condition system
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The contralateral eye served as control.
- Amount / concentration applied:
- 0.1 g of the finely grounded test item was used for the study, as a single dose.
- Duration of treatment / exposure:
- The eyes of the test animals were not washed out 24 hour after test item application, because the test item had been removed from the eye of test animal by physiological mechanisms.
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours, then 1, 2 and 3 weeks after the application.
- Number of animals or in vitro replicates:
- 3 male
- Details on study design:
- In the first step an initial test was performed using one animal. The test item was placed into the conjunctival sac of the left eye. The eyelids were held closed gently for about one second to prevent any loss of the test item. The contralateral eye served as control.
In the initial test slight to moderate irritant effect was observed 24 hours after treatment. The confirmatory test was conducted using a second animal. Slight to moderate irritant effects were observed 24 hour after treatment. Following treatment of the second animal, the third confirmatory test was conducted using a third animal.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 3 weeks
- Remarks on result:
- other: in one animal
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- other: redness (conjunctival)
- Basis:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 1 - 1.33
- Max. score:
- 1.33
- Reversibility:
- not fully reversible within: 3 weeks
- Remarks on result:
- other: in one animal
- Irritation parameter:
- chemosis score
- Remarks:
- (conjunctival)
- Basis:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0.66 - 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 3 weeks
- Remarks on result:
- other: in one animal
- Irritation parameter:
- other: conjunctival discharge
- Basis:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0.33 - 1.33
- Max. score:
- 1.33
- Reversibility:
- not fully reversible within: 3 weeks
- Remarks on result:
- other: in one animal
- Irritant / corrosive response data:
- Treated and control eyes were examined at 1, 24, 48 and 72 hours, then 1, 2 and 3 weeks after the application.
1 hour after the single application of test item into the eye of the rabbits, slight redness, slight to moderate chemosis, moderate to severe discharge of the conjunctivae and slight cornea opacity occurred, as well.
1 week after treatment slight redness, chemosis and discharge of the conjunctivae and slight cornea opacity occurred in one animal, as well. The area of cornea involved was greater than one quarter, but less than half in two animals and the area of cornea involved was greater than one quarter, but not zero (score 1) in one animal, as well. The area of cornea involved was greater than half, but less than three quarters (score 3). Two animals became free of symptoms by this observation time.
2 weeks after treatment two animals were free of symptoms. Moderate redness, moderate to severe chemosis, severe discharge of the conjunctivae and moderate to severe cornea opacity occurred in one animal. The area of cornea involved was greater than three quarters, up to the whole area (score 4).
3 weeks after treatment two animals were free of symptoms. Severe redness, moderate to severe chemosis, severe discharge of the conjunctivae and severe cornea opacity occurred in one animal. The area of cornea involved was greater than three quarters, up to the whole area (score 4).
Three weeks after the treatment the study was finished, because the cornea opacity and symptoms of conjunctivae have not fully reversed within an observation period of 21 days in one animal.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- In conclusion, test item 4-NITROPHENYL-ACETIC ACID (CAS 104-03-0) applied to the rabbits' eye mucosa caused conjunctival and cornea irritant effects which were fully reversible within 1 week in two animals, but the conjunctival effects and effect on the cornea did not reverse within an observation period of 21 days in one animal. The test item should be classified into “Category 1 (irreversible effects on the eye/serious damage to eyes)”.
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