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EC number: 296-120-8 | CAS number: 92257-31-3
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study methodology followed was equivalent or similar to OECD TG 405 and in accordance with the Principles of Good Laboratory Practice (GLP)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar-heptyl ar',ar''-Me derivs.
- EC Number:
- 296-120-8
- EC Name:
- 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar-heptyl ar',ar''-Me derivs.
- Cas Number:
- 92257-31-3
- Molecular formula:
- Not applicable
- IUPAC Name:
- 2-Naphthalenol, 1-[2-[4-(2-phenyldiazenyl)phenyl]diazenyl]-, ar-heptyl ar',ar''-Me derivatives *
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Test Animals:
-Source: New York State Rabbit Development, Hartwick, N.Y.
-Weight at study initiation: Approximately 2-4kg
-Housing: Individually housed in wire mesh bottom cages
-Food: NIH Animal feed A, ad libitum
-Water: Tap water, ad libitum
-Acclimation period: minimum of 5 days
Environmental Conditions
-Temperature (C): as per "Guide for the Care and Use of Laboratory Animals"
-Humidity (%): as per "Guide for the Care and Use of Laboratory Animals"
-Air Changes (per hr): 12-15 air changes/hour
-Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: One eye for each animal served as untreated control.
- Amount / concentration applied:
- A volume of 0.1 ml instilled in the everted lower lid of one eye of each animal. The other eye served as the untreated control.
- Duration of treatment / exposure:
- The lids of the treated eyes of the animals were held closed for one second following instillation and were not irrigated. The animal was then returned to it's cage.
- Observation period (in vivo):
- Observations for eye irritation were made at 1, 24, 48, and 72 hours and again at 7 days after application of the test article.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Method:
Animals wiil be weighed and weights recorded prior to the initiation of the study.
Approximately 24 hours prior to test initiation, the eyes of each rabbit were examined with sodium fluorescein and an ultraviolet lamp. Only those
rabbits whose eyes were free of irritation and corneal lesions were used.
A volume of 0.1 ml was instilled in one eye of each rabbit by gently pulling the lower lid away from the eyeball to form a cup into which the test article was deposited. The lids were then held together for one second after which the animal was returned to its cage. The treated eyes were not irrigated.
With the untreated eye serving as a control, the eyes were examined using fluorescein dye procedures and the grade of ocular reaction for each animal was recorded at 1, 24, 48 and 72 hours and again at 7 days using the Draize Scale for Scoring Ocular Lesions. If injury persisted the eyes were further examined and scored every 3 days for 13 days or until all signs of reversible irritation subsided.
Test Article Classification:
The mean eye irritation score and the standard deviation of the mean were determined for each observation period. The greatest mean score observed was used to assign the test article an ocular irritation rating in accordance with the classification system of Draize.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: Mean score for all animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- other: Mean score for all animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- other: Mean score for all animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- other: Mean score for all animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- See results section.
Any other information on results incl. tables
Individual Rabbit Eye Irritation Scores
|
|
|
Reading |
||||
Rabbit Number |
Item |
Tissue |
1 hr |
24 hr |
48 hr |
72 hr |
Day 7 |
0906NW |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
0 |
|
B |
Cornea Area |
0 |
0 |
0 |
0 |
0 |
|
(1) |
Cornea Total=(AxB)x5 |
0 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
0 |
|
(2) |
Iris Total=(C)x5 |
0 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
0 |
0 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
0 |
0 |
0 |
0 |
0 |
|
(3) |
Conjunctiva Total (D+E+F)x2 |
0 |
0 |
0 |
0 |
0 |
|
|
Totals Added= (1+2+3) |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
0874NW |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
0 |
|
B |
Cornea Area |
0 |
0 |
0 |
0 |
0 |
|
(1) |
Cornea Total=(AxB)x5 |
0 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
0 |
|
(2) |
Iris Total=(C)x5 |
0 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
0 |
0 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
0 |
0 |
0 |
0 |
0 |
|
(3) |
Conjunctiva Total (D+E+F)x2 |
0 |
0 |
0 |
0 |
0 |
|
|
Totals Added= (1+2+3) |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
0875NW |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
0 |
|
B |
Cornea Area |
0 |
0 |
0 |
0 |
0 |
|
(1) |
Cornea Total=(AxB)x5 |
0 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
0 |
|
(2) |
Iris Total=(C)x5 |
0 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
0 |
0 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
0 |
0 |
0 |
0 |
0 |
|
(3) |
Conjunctiva Total (D+E+F)x2 |
0 |
0 |
0 |
0 |
0 |
|
|
Totals Added= (1+2+3) |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
0877NW |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
0 |
|
B |
Cornea Area |
0 |
0 |
0 |
0 |
0 |
|
(1) |
Cornea Total=(AxB)x5 |
0 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
0 |
|
(2) |
Iris Total=(C)x5 |
0 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
0 |
0 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
0 |
0 |
0 |
0 |
0 |
|
(3) |
Conjunctiva Total (D+E+F)x2 |
0 |
0 |
0 |
0 |
0 |
|
|
Totals Added= (1+2+3) |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
0878NW |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
0 |
|
B |
Cornea Area |
0 |
0 |
0 |
0 |
0 |
|
(1) |
Cornea Total=(AxB)x5 |
0 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
0 |
|
(2) |
Iris Total=(C)x5 |
0 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
0 |
0 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
0 |
0 |
0 |
0 |
0 |
|
(3) |
Conjunctiva Total (D+E+F)x2 |
0 |
0 |
0 |
0 |
0 |
|
|
Totals Added= (1+2+3) |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
0799NW |
A |
Cornea Opacity |
0 |
0 |
0 |
0 |
0 |
|
B |
Cornea Area |
0 |
0 |
0 |
0 |
0 |
|
(1) |
Cornea Total=(AxB)x5 |
0 |
0 |
0 |
0 |
0 |
|
C |
Iris |
0 |
0 |
0 |
0 |
0 |
|
(2) |
Iris Total=(C)x5 |
0 |
0 |
0 |
0 |
0 |
|
D |
Conjunctiva Redness |
0 |
0 |
0 |
0 |
0 |
|
E |
Conjunctiva Chemosis |
0 |
0 |
0 |
0 |
0 |
|
F |
Conjunctiva Discharge |
0 |
0 |
0 |
0 |
0 |
|
(3) |
Conjunctiva Total (D+E+F)x2 |
0 |
0 |
0 |
0 |
0 |
|
|
Totals Added= (1+2+3) |
0 |
0 |
0 |
0 |
0 |
Initial Body Weights:
Animal Number Initial Body Weight (kg)
82 -0906 M 2.70
82 -0874 M 2.85
82 -0875 M 2.87
82 -0877 M 2.83
82 -0878 M 2.94
82 -0799 M 2.75
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, the test material is not considered corrosive to the eyes of rabbits.
- Executive summary:
The eye irritation potential of the test material was evaluated in 6 New Zealand White rabbits. Animal body weights were recorded prior to the initiation of the study. Approximately 24 hours prior to test initiation, the eyes of each rabbit were examined with sodium fluorescein and an ultraviolet lamp. Only those rabbits whose eyes were free of irritation and corneal lesions were used. A volume of 0.1 ml was instilled in one eye of each rabbit by gently pulling the lower lid away from the eyeball to form a cup into which the test article was deposited. The lids were then held together for one second after which the animal was returned to its cage. The treated eyes were not irrigated. With the untreated eye serving as a control, the eyes were examined using fluorescein dye procedures and the grade of ocular reaction for each animal was recorded at 1, 24, 48 and 72 hours and again at 7 days using the Draize Scale for Scoring Ocular Lesions. Under the conditions of the study, The test material is not considered corrosive to the eyes of rabbits.
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