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Diss Factsheets
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EC number: 215-863-0 | CAS number: 1435-71-8
- 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: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-[(o-nitrophenyl)azo]-p-cresol
- EC Number:
- 215-863-0
- EC Name:
- 2-[(o-nitrophenyl)azo]-p-cresol
- Cas Number:
- 1435-71-8
- Molecular formula:
- C13H11N3O3
- IUPAC Name:
- 4-methyl-2-[(2-nitrophenyl)diazenyl]phenol
- Details on test material:
- - Identification: TK 40136
- Product name: Monoazo 3113
- Physical state: Red-brownish solid
- Analytical purity: > 95%
- Lot/batch No.: Pa 369
- Expiration date of the lot/batch: November 01, 1997
- Stability under storage conditions: Stable
- Storage condition of test material: At room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, Netherlands
- Age at study initiation: Approx. 7 weeks
- Weight at study initiation: 1541 - 1856 grams
- Housing: single
- Diet: Standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, Netherlands); approx. 100 g per day; in addition, hay (BMI, Helmond, the Netherlands) was provided once a week;
- Water: Free access to tap-water diluted with decalcified water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approximately 47+/- 0.9 mg of test substance (a volume of approximately 0.1 ml) - Duration of treatment / exposure:
- see observation period, no washing out conducted
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 male animals
- Details on study design:
- SCORING SYSTEM: according to OECD 405 / Draize; from the maximum (mean) Draize score, an eye irritation rating was obtained based on: Draize, Woodard & Calvery (1944) J.Pharmacol.Exp.Ther. 82, 377; Kay & Calandra (1962) J.Soc.Cosmet.Chem. 13, 281;
TOOL USED TO ASSESS SCORE: Immediately after the 24 hour observation, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area. In case standard lighting was considered inadequate for observing minor effects, eye examinations were performed using an ophthalmic examination lamp.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24 - 48 - 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- other: see table below for details
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24 - 48 - 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed
- Remarks on result:
- other: see table below for details
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24 - 48 - 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects observed
- Remarks on result:
- other: redness (score 1) observed at the 1 hour-reading in all 3 animals; reversible within 24 hours; see table below for details
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24 - 48 - 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- other: chemosis (score 1) observed in 1 animal at the 1 hour-reading; reversible within 24 hours; see table below for details;
- Irritant / corrosive response data:
- Treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals.
- Other effects:
- Remnants of the test substance were noted on the outside of the eyelids of all animals throughout the study period. No signs of systemic intoxication were observed during the study period.
Any other information on results incl. tables
Animal | Reading | Cornea | Iris | Conjunctiva | ||||
Opacity | Area involved | Redness | Chemosis | Discharge | Comment | |||
1 | 1 h | 0 | 0 | 0 | 1 | 0 | 1 | Remnants of the test substance in the eye/on the outside of the eyelids |
2 | 1 h | 0 | 0 | 0 | 1 | 0 | 1 | Remnants of the test substance in the eye/on the outside of the eyelids |
3 | 1 h | 0 | 0 | 0 | 1 | 1 | 1 | Remnants of the test substance in the eye/on the outside of the eyelids |
1 | 24 hrs | 0 | 0 | 0 | 0 | 0 | 0 | Remnants of the test substance on the outside of the eyelids |
2 | 24 hrs | 0 | 0 | 0 | 0 | 0 | 0 | Remnants of the test substance on the outside of the eyelids |
3 | 24 hrs | 0 | 0 | 0 | 0 | 0 | 0 | Remnants of the test substance on the outside of the eyelids |
1 | 48 hrs | 0 | 0 | 0 | 0 | 0 | 0 | Remnants of the test substance on the outside of the eyelids |
2 | 48 hrs | 0 | 0 | 0 | 0 | 0 | 0 | Remnants of the test substance on the outside of the eyelids |
3 | 48 hrs | 0 | 0 | 0 | 0 | 0 | 0 | Remnants of the test substance on the outside of the eyelids |
1 | 72 hrs | 0 | 0 | 0 | 0 | 0 | 0 | Remnants of the test substance on the outside of the eyelids |
2 | 72 hrs | 0 | 0 | 0 | 0 | 0 | 0 | Remnants of the test substance on the outside of the eyelids |
3 | 72 hrs | 0 | 0 | 0 | 0 | 0 | 0 | Remnants of the test substance on the outside of the eyelids |
1 | 24/48/72 hrs | 0 | 0 | 0 | 0 | |||
2 | 24/48/72 hrs | 0 | 0 | 0 | 0 | |||
3 | 24/48/72 hrs | 0 | 0 | 0 | 0 | |||
mean animal 1-3 | 24/48/72 hrs | 0 | 0 | 0 | 0 |
The maximum (mean) Draize score was 4.7.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is considered not irritant to eyes.
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