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EC number: 295-118-4 | CAS number: 91844-53-0
- 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:
- 26 Feb - 04 March 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministerium für Umwelt, Landwirtschaft und Verbraucherschutz des Landes Nordrhein-Westfalen, Düsseldorf, Germany
Test material
- Reference substance name:
- Sorbitan, octanoate (2:3)
- EC Number:
- 295-118-4
- EC Name:
- Sorbitan, octanoate (2:3)
- Cas Number:
- 91844-53-0
- Molecular formula:
- Not available for UVCB
- IUPAC Name:
- Sorbitan, octanoate (2:3)
- Details on test material:
- - Name of test material (as cited in study report): Sorbitan-octanoate(2:3)
- Substance type: organic
- Physical state: amber viscous liquid
- Analytical purity: 100%
- Lot/batch No.: ES66941443
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Kissleg, Germany
- Weight at study initiation: 2,053.8 g and 2,155.2 g (female), 1,805.8 g (male)
- Housing: Single in steel cages with a plastic bottom mould and a habitat of 5445 square centimetres at the bottom and an overall height of 600 millimetres. A non-barrier system with air conditioning was used.
- Diet: Food type “2023" from Altromin International, Lage, Germany as pelleted diet (Batch No.: 1105; expiry date: 2008-09-03), ad libitum.
- Water: Drinking water consisted of normal tap water from municipal source (SWK AQUA GmbH, Krefeld, Germany), ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C ± 3 °C
- Humidity (%): 30% - 70%
- Air changes (per hr): 8 times/h
- Photoperiod (hrs dark / hrs light): dimmed light, no further data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- 0.1 mL / 100%
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 days
Reading time points: 1, 24, 48 and 72 h and 7 days - Number of animals or in vitro replicates:
- 1 male and 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: the treated eye was rinsed with saline solution
- Time after start of exposure: 24 h
SCORING SYSTEM: according to guideline
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- All 3 animals showed slight ocular reaction 1 h after application of the test substance (one score each for conjunctivae redness, chemosis and discharge at three animals and one score for slight reaction of the iris at one animal). 24 h after application slight redness and chemosis was still observed in all three animals. 7 days after application all three animals were without any sign of ocular irritation. Cornea damage was not observed at any time during the study.
Any other information on results incl. tables
Table 1: Numerical scores awarded to the ocular reactions elicited by the test substance in animal 1.
Animal #1 |
|
1h |
24h |
48h |
72h |
7d |
mean (24-72h) |
Cornea opacity |
A |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea area |
B |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
A |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae redness |
A |
1 |
1 |
1 |
1 |
0 |
1 |
Conjunctivae chemosis |
B |
1 |
1 |
0 |
0 |
0 |
0.33 |
Conjunctivae discharge |
C |
1 |
0 |
0 |
0 |
0 |
0 |
Table 2: Numerical scores awarded to the ocular reactions elicited by the test substance in animal 2.
Animal #2 |
|
1h |
24h |
48h |
72h |
7d |
mean (24-72h) |
Cornea opacity |
A |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea area |
B |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
A |
1 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae redness |
A |
1 |
1 |
1 |
0 |
0 |
0.67 |
Conjunctivae chemosis |
B |
1 |
1 |
0 |
0 |
0 |
0.33 |
Conjunctivae discharge |
C |
1 |
0 |
0 |
0 |
0 |
0 |
Table 3: Numerical scores awarded to the ocular reactions elicited by the test substance in animal 3.
Animal #3 |
|
1h |
24h |
48h |
72h |
7d |
mean (24-72h) |
Cornea opacity |
A |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea area |
B |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
A |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae redness |
A |
1 |
1 |
0 |
0 |
0 |
0.33 |
Conjunctivae chemosis |
B |
1 |
1 |
0 |
0 |
0 |
0.33 |
Conjunctivae discharge |
C |
1 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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