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Diss Factsheets
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EC number: 200-683-7 | CAS number: 68-26-8
- 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
- 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
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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 guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
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)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nosan No. 8147.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- Retinol 50 C, a technical preparation of retinol (CAS-No. 68-26-8);
content of the active substance was 47.7 g/100 g (analytical report no. 99C04293).
Physical state / appearance : At storage conditions : solid / yellow; After heating at approx. 50°C: liquid, oil / yellow
Storage conditions : In a refrigerator, exclusion of light and oxygen (stored under nitrogen)
Batch No. : 50-2498
Date of production : November 15, 2001
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Centre Lage, Vonnas (France)
- Age at study initiation: 4-5 months
- Weight at study initiation: 3.33-3.48 kg
- Water: ad libitum
- Housing: Single housing in wire mesh cages with grating, floor area: 3000 square cm
- Diet: about 130 g/animal per day (Labordiät, Provimi Kliba SA, Kaiseraugst, Switzerland)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated left eye of each rabbit served as control.
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- 24 hour(s)
- Observation period (in vivo):
- The eyes were scored at 1 hour, 24, 48, 72 hours, and 8 days after instillation.
- Number of animals or in vitro replicates:
- 3 (2 males, 1 female)
- Details on study design:
- One tenth millilitre of the unchanged, liquid test material (i.e. a ca. 50% solution of retinol; no data on solvent and/or contaminants) was instilled into the conjunctival sac of the right eye of each of three New Zealand white rabbits. The test material was washed out (rinsed) with tap water about 24 hours after instillation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
Any other information on results incl. tables
Table: Individual Draize scores for cornea (opacity, area involved), iris, and
conjunctivae (redness, chemosis, discharge) and additional findings
animal cornea iris conjunctivae add.
no op. area redn. chem. disc. find.
---------------------------------------------------------
1-hour reading
1 0 0 0 3 2 2 DB, 48
2 0 0 0 3 2 2
3 0 0 0 3 2 2
- - - - - - - - - - - - - - - - - - - - - - - - - - - - -
24-hour reading
1 0 0 0 3 2 3 DB, 48
2 0 0 0 3 3 0 49
3 0 0 0 3 2 2 49
- - - - - - - - - - - - - - - - - - - - - - - - - - - - -
48-hour reading
1 0 0 0 3 1 0 48
2 0 0 0 2 1 0 48
3 0 0 0 2 1 0 48
- - - - - - - - - - - - - - - - - - - - - - - - - - - - -
72-hour reading
1 0 0 0 2 1 0 48
2 0 0 0 1 1 0 48
3 0 0 0 2 1 0 48
- - - - - - - - - - - - - - - - - - - - - - - - - - - - -
7-day-reading
1 0 0 0 0 0 0
2 0 0 0 0 0 0
3 0 0 0 0 0 0
---------------------------------------------------------
individual mean scores
1 0.0 0.0 2.7 1.3
2 0.0 0.0 2.0 1.7
3 0.0 0.0 2.3 1.3
---------------------------------------------------------
total mean score (mean of 3)
0.0 0.0 2.3 1.4
---------------------------------------------------------
codes used for additional findings:
DB = discharge of blood
48 = scleral vessels injected, circumscribed area
49 = scleral vessels injected, circular
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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