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EC number: 270-616-4 | CAS number: 68459-67-6
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- no information on purity of test substance given; limited documentation; scoring of conjunctivae as redness, chemosis and discharge in combined score only
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 02 Oct 2012
- Deviations:
- yes
- Remarks:
- limited documentation; scoring of conjunctivae as redness, chemosis and discharge in combined score only
- Qualifier:
- according to guideline
- Guideline:
- other: F.D.A. Handbook, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, F.D.A. (1959), p. 47.
- GLP compliance:
- no
Test material
- Reference substance name:
- Castor oil, ester with glycerol
- EC Number:
- 270-616-4
- EC Name:
- Castor oil, ester with glycerol
- Cas Number:
- 68459-67-6
- Molecular formula:
- not applicable, substance is UVCB
- IUPAC Name:
- Castor oil, ester with glycerol
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- single application without washing, 2 and 4 sec
- Observation period (in vivo):
- 7 days
Reading time points: 1, 2, 3, 4 and 7 days - Number of animals or in vitro replicates:
- 3 per group (no washing, 2 and 4 sec exposure)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Treated eyes where washed with 20 mL lukewarm water.
- Time after start of exposure: 2 or 4 sec
SCORING SYSTEM: Draize scoring system; scoring of conjunctivae as redness, chemosis and discharge was given in combined score only (Scores of Redness + Chemosis + Discharge) x 2 = 20 (Maximum score)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: treated eye not washed
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: treated eye not washed
- Irritation parameter:
- conjunctivae score
- Remarks:
- scoring of conjunctivae as redness, chemosis and discharge in combined score only
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 20
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: treated eye not washed
- Irritation parameter:
- conjunctivae score
- Remarks:
- scoring of conjunctivae as redness, chemosis and discharge in combined score only
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 20
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: treated eye not washed
- Irritation parameter:
- conjunctivae score
- Remarks:
- scoring of conjunctivae as redness, chemosis and discharge in combined score only
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 20
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: treated eye not washed
- Irritation parameter:
- chemosis score
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- The test substance produced mild conjunctival irritation (total conjunctivae score 4 and 6) 24 h after instillation without washing in all 3 rabbits. This conjunctival irritation was reversible within 48 h.
In rabbits in which the treated eyes were washed after 2 or 4 sec no irritation was observed at any observation time point.
Any other information on results incl. tables
Table 1: Results of Draize test in unwashed eye
Alteration |
Animal No. |
Time (h) |
||||
24 |
48 |
72 |
mean 24/48/72 h |
reversible within |
||
Cornea |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae Redness + Chemosis + Discharge * |
1 |
4 |
0 |
0 |
0 |
0 |
2 |
4 |
0 |
0 |
0 |
0 |
|
3 |
6 |
0 |
0 |
0 |
0 |
* Combined scores only; (Scores of redness + chemosis + discharge) x 2 = 20 (maximum score)
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions of this eye irritation study in rabbits the test substance was not irritating to the eye.
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