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EC number: 308-760-8 | CAS number: 98246-87-8
- 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
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- Endpoint summary
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- 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
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
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- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 8 September 1998 - 12 September 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to international guidelines and under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 849705-80-2
- Cas Number:
- 849705-80-2
- IUPAC Name:
- 849705-80-2
- Details on test material:
- Identity: P-2290
Chemical name: 2-Oxetanone, 3-(C14-16 and C16-unsatd. branched and linear alkyl) 4-(C15-17 and C17-unsatd. branched and linear alkylidene) derivs
Appearance: Brown waxy liquid
Storage conditions: 4°C in the dark
Batch number: No data
Composition: Alkyl ketene dimer > 85%, Toluene <20ppm
Sample receive: 8 May 1998
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, Oxon, England.
- Age at study initiation: 16 weeks
- Weight at study initiation: 3.0-3.4 kg
- Housing: They were housed individually in metal cages with perforated floors in Building R14 Room 4
- Diet (e.g. ad libitum): ad libitum, standard laboratory rabbit diet (Special Diet Services STANRAB (P) SQC pellet)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 34 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5-20
- Humidity (%): 43-66
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 8 September 1998 - 12 September 1998
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as the control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- One single exposure
- Observation period (in vivo):
- Until 3 days after instillation
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not performed
SCORING SYSTEM:
Cornea opacity: degree of density (area most dense taken for reading)
0 No ulceration or opacity
1 Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2 Easily discernible translucent areas, details of iris slightly obscured
3 Nacreous areas, no details of iris visible, size of pupil barely discernible
4 Opaque cornea, iris not discernible through the opacity
Area of cornea involved:
0 None
1 One quarter (or less) but not zero
2 Greater than one quarter, but less than half
3 Greater than half, but less than three quarters
4 Greater than three quarters, up to whole area
Iris:
0 Normal
1 Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2 No reaction to light, haemorrhage, gross destruction (any or all of these)
Conjunctivae Redness: (refers to the most severe reading of palpebral and bulbar conjunctivae, as compared to the control eye)
0 Blood vessels normal
1 Some blood vessels definitely hyperaemic (injected)
2 Diffuse, crimson colour, individual vessels not easily discernible
3 Diffise beefy red
Chemosis: (lids and/or nictating membranes)
0 No swelling
1 Any swelling above normal (includes nictating membranes)
2 Obvious swelling with partial eversion of lids
3 Swelling with lids about half-closed
4 Swelling with lids more than half-closed
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24-48-72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24-48-72 hours
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: No effects observed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24-48-72 hours
- Score:
- 0.22
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24-48-72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No effects observed
- Irritant / corrosive response data:
- No corneal damage or iridial inflammation was observed. A diffuse, crimson colouration of the conjunctivae was seen in one animal. Transient hyperaemia of the blood vessels was seen in the remaining two animals. These reactions had resolved by one or two days after instillation.
- Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
Any other information on results incl. tables
Anim. No. |
Effect |
Days after application |
Mean score cornea Days 1/2/3 |
Mean score iritis Days 1/2/3 |
Mean score redness Days 1/2/3 |
Mean score chemosis Days 1/2/3 |
Mean score discharge Days 1/2/3 |
|||
1 (hour) |
1 |
2 |
3 |
|||||||
1123* |
Cornea-opacity Cornea-area Iris Redness Chemosis Discharge |
0 0 0 2 0 - |
0 0 0 1 0 - |
0 0 0 0 0 - |
0 0 0 0 0 - |
0 |
0 |
0.33 |
0 |
- |
1188 |
Cornea-opacity Cornea-area Iris Redness Chemosis Discharge |
0 0 0 1 0 - |
0 0 0 1 0 - |
0 0 0 0 0 - |
0 0 0 0 0 - |
0 |
0 |
0.33 |
0 |
- |
1189 |
Cornea-opacity Cornea-area Iris Redness Chemosis Discharge |
0 0 0 1 0 - |
0 0 0 0 0 - |
0 0 0 0 0 - |
0 0 0 0 0 - |
0 |
0 |
0 |
0 |
- |
Mean all anim. |
0 |
0 |
0.22 |
0 |
- |
- No scoring performed
* pilot animal
Applicant's summary and conclusion
- Conclusions:
- Based on the scores for this study the test substance is not classified for eye irritation according to OECD GHS criteria.
- Executive summary:
A study was performed to assess the eye irritation potential of P-2290 to the rabbit. The method followed was that described in the following guidelines: EEC Methods for the determination of toxicity, Annex to Directive 92/69/EEC (Official Journal No. L383Ay 29.12.92), Part B, Method B.5. Acute toxicity (eye irritation). OECD Guideline for the Testing of Chemicals No. 405, "Acute Eye lrritation/Corrosion", Adopted 24 February 1987.
Thee rabbits were each administered a single ocular dose of a volume of 0.1 ml of the test substance, and observed for three days after instillation.
A single instillation of P-2290 into the eye of the rabbit elicited transient very slight to well-defined conjunctival irritation only. All reactions had resolved by two days after instillation. Based on the scores for this study the test substance is not classified for eye irritation according to OECD GHS criteria.
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