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EC number: 271-213-6 | CAS number: 68526-56-7
- 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
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- Nanomaterial radical formation potential
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- Endpoint summary
- Stability
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- 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
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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 compliant, guideline study, available as unpublished report, minor reporting restrictions, otherwise adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- CAS 68478-10-4
- IUPAC Name:
- CAS 68478-10-4
- Reference substance name:
- E000044012
- IUPAC Name:
- E000044012
- Details on test material:
- - Name of test material (as cited in study report): E000044012
- Clear, pale yellow to yellow-coloured liquid; disagreeable odour
- Specific gravity: AP = 0.87 - 0.91 (H2O = 1 at 39.2°F)
- Flash point: AP = 75°F
- Analytical purity: no data
- Test material data on file with the study sponsor
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Sterling Rabbitry, Wellsville, Utah, USA
- Sex: 4 males and 2 females
- Age at study initiation: young adult
- Weight at study initiation: 2.0 - 4.0 kg
- Housing: Individually, in stainless steel, wire mesh bottom cages
- Diet: Agway rabbit feed ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 61 - 70°F
- Humidity: 40 - 60%
- Air changes: At least 10per hr
- Photoperiod: 12 hrs dark/12 hrs light
IN-LIFE DATES: From: 20 February 1990 To: 23 February 1990
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- Single dose
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- The test article was placed in the right eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test article was dropped. The upper and lower lids were gently held together for approximately one second to prevent loss of test material.
Animal body weights were taken within 48 hours of receipt and prior to dosing. All animals were sacrificed following the 72 hour scoring period.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no corneal effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: no iridial effects
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No cornea effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: No iridial effects
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: minimal to marked effects in all 6 rabbits
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: very slight to slight effects in all 6 rabbits
Any other information on results incl. tables
Eye irritation scores according to the Draize scheme
Time |
Conjunctivae, redness |
Conjunctivae, chemosis |
||||||||||
Animal number |
81 |
86 |
93 |
100 |
102 |
103 |
81 |
86 |
93 |
100 |
102 |
103 |
after 1 hour |
3 |
2 |
3 |
3 |
3 |
3 |
3 |
1 |
3 |
3 |
2 |
2 |
after 24 hours |
3 |
2 |
3 |
3 |
3 |
1 |
2 |
1 |
2 |
2 |
1 |
1 |
after 48 hours |
2 |
2 |
2 |
2 |
3 |
1 |
2 |
1 |
2 |
2 |
1 |
1 |
after 72 hours |
2 |
2 |
2 |
2 |
3 |
1 |
2 |
1 |
2 |
2 |
1 |
1 |
mean scores 24-72h |
2.3 |
2.0 |
2.3 |
2.3 |
3.0 |
1.0 |
2.0 |
1.0 |
2.0 |
2.0 |
1.0 |
1.0 |
Discharge seen in all 6 animals after 1 hour and in 2 animals after 24 hours |
Applicant's summary and conclusion
- Interpretation of results:
- other: Irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- E000044012 is irritating to the rabbit eye.
- Executive summary:
Eye irritation potential of E000044012 (CAS 68478-10-4) was determined in a group of six albino rabbits.
There was no evidence of damage to the cornea or iris throughout the study. Conjunctival redness and chemosis was seen from 1 hour to 72 hours after application.
It can be concluded that E000044102 (CAS 68478-10-4) is not irritating to the rabbit eye. Under GHS/CLP classification, it triggers "Causes serious eye irritation" Cat 2A, H319.
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