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Diss Factsheets
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EC number: 268-871-1 | CAS number: 68153-22-0
- 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
- Study period:
- 3rd December 2001 to 6th December 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hydrocarbon waxes (petroleum), oxidized
- EC Number:
- 265-205-1
- EC Name:
- Hydrocarbon waxes (petroleum), oxidized
- Cas Number:
- 64743-00-6
- Molecular formula:
- too complex
- IUPAC Name:
- Hydrocarbon waxes (petroleum), oxidized
- Test material form:
- other: greasy solid
- Details on test material:
- - Physical appearance: Light brown semi-solid.
- Storage condition of test material: Room temperature and humidity.
- TAN: 24 - 40
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Millbrook Breeding Lads, Amherst, MA on 31/10/01.
- Only healthy animals free from ocular damage were selected for this study.
- Age at study initiation: Born on 02/09/01.
- Weight at study initiation: 3.2 - 3.4 kg.
- Housing: Individually in suspended cages.
- Diet (e.g. ad libitum): Purina Rabbit Chow, diet # 5321, supplied by Purina Mills, Inc. Feed daily.
- Water (e.g. ad libitum): as libitum.
- Quarantine period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Controlled.
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The contralateral eye served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml/rabbit. - Observation period (in vivo):
- - Total of 72 hours.
- Number of animals or in vitro replicates:
- - Three female animals.
- Details on study design:
- METHOD
- The test material was placed into the conjunctival sac, formed by gently pulling the lower eyelid away from the eye. The lid was held closed for a second, before the animal was released.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No.
SCORING SYSTEM: Draize scale (1977), which can be seen in table 1.
OBSERVATIONS
-Time points: 1, 24, 48 and 72 hours.
- General health was recorded at each time point.
- Body weights were recorded before exposure.
TOOL USED TO ASSESS SCORE:
- A Mini-Maglite® was during ocular examinations.
- Sodium fluorescein dye was used at 24 hours.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No reaction observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: No reaction observed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No reaction observed
- Irritant / corrosive response data:
- There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation, noted in 3/3 eyes, cleared within 72 hours.
- Other effects:
- - No abnormal physical signs were noted during the observation period.
Any other information on results incl. tables
Table 2. Results for Ocular Damage.
Animal No. | Tissue | Reading | 1 hr | 24 hrs | 48 hrs | 72 hrs | Mean Score from 24, 48 and 72 hours |
1 | Cornea | Opacity | 0 | 0 | 0 | 0 | 0 |
Area | 0 | 0 | 0 | 0 | |||
SubTotal | 0 | 0 | 0 | 0 | |||
Iris | 0 | 0 | 0 | 0 | 0 | ||
SubTotal | 0 | 0 | 0 | 0 | |||
Conjunctiva | Redness | 2 | 0 | 0 | 0 | 0 | |
Chemosis | 2 | 0 | 0 | 0 | 0 | ||
Discharge | 2 | 0 | 0 | 0 | |||
SubTotal | 12 | 0 | 0 | 0 | |||
Total | 12 | 0 | 0 | 0 | |||
2 | Cornea | Opacity | 0 | 0 | 0 | 0 | 0 |
Area | 0 | 0 | 0 | 0 | |||
SubTotal | 0 | 0 | 0 | 0 | |||
Iris | 0 | 0 | 0 | 0 | 0 | ||
SubTotal | 0 | 0 | 0 | 0 | |||
Conjunctiva | Redness | 2 | 1 | 0 | 0 | 0.33 | |
Chemosis | 2 | 0 | 0 | 0 | 0 | ||
Discharge | 2 | 0 | 0 | 0 | |||
SubTotal | 12 | 2 | 0 | 0 | |||
Total | 12 | 2 | 0 | 0 | |||
3 | Cornea | Opacity | 0 | 0 | 0 | 0 | 0 |
Area | 0 | 0 | 0 | 0 | |||
SubTotal | 0 | 0 | 0 | 0 | |||
Iris | 0 | 0 | 0 | 0 | 0 | ||
SubTotal | 0 | 0 | 0 | 0 | |||
Conjunctiva | Redness | 2 | 1 | 1 | 0 | 0.66 | |
Chemosis | 2 | 0 | 0 | 0 | 0 | ||
Discharge | 2 | 0 | 0 | 0 | |||
SubTotal | 12 | 2 | 2 | 0 | |||
Total | 12 | 2 | 2 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- Under the conditions of the test, the test material was determined to be non-irritating according to Regulation (EC) 1272/2008. The material tested in this study has a TAN range of 24-40. The observed ocular effects in the three animals were not severe enough to warrant classification. Initially animals displayed mild chemosis and discharge which completely cleared by 24 hours. Two of the three animals showed mild conjunctiva redness which was completely reversible within 72 hours.
- Executive summary:
In a GLP compliant study performed according to the standardised guideline EPA OPPTS 870.2440, the ocular irritation caused by exposure to the test material was assessed in three rabbits. They were exposed to 0.1 ml of the test material using their contralateral eye as a control. Initially some mild irritation (chemosis and discharge) was observed, however this did not persist past 1 hour. Conjunctiva redness was the parameter which persisted past 1 hour and was assigned an average score of 0.33 according to the Draize scale (1977), this was completely reversible within 72 hours. Under the conditions of this study the test material (which has a TAN range of 24 - 40) does not require classification as an eye irritant in line with Regulation (EC) 1272/2008.
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