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EC number: 204-844-2 | CAS number: 127-47-9
- 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 18 September 1984 - 21 September 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted equivalent to OECD guideline 428, but not under GLP conditions.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Deviations:
- no
- Principles of method if other than guideline:
- Not relevant
- GLP compliance:
- no
Test material
- Reference substance name:
- Retinyl acetate
- EC Number:
- 204-844-2
- EC Name:
- Retinyl acetate
- Cas Number:
- 127-47-9
- Molecular formula:
- C22H32O2
- IUPAC Name:
- (2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-en-1-yl)nona-2,4,6,8-tetraen-1-yl acetate
- Details on test material:
- - Name of test material (as cited in study report): Vitamin-A-Acetate 14C, Retinyl acetate
- Physical state: Test material was dissolved in TWEEN-20 and NEOBEE-M-5
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14C
Test animals
- Species:
- rat
- Strain:
- other: naked rat
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Not relevant
Administration / exposure
- Type of coverage:
- other: Closed system
- Vehicle:
- other: TWEEN-20 and NEOBEE-M-5
- Duration of exposure:
- 6 hours
- Doses:
- - Nominal doses:
In TWEEN-20: 150 ug/cm2 (2.5% solution)
In NEOBEE-M-5: 600 ug/cm2 (10% solution)
- Dose volume: 6 ul/cm2 - No. of animals per group:
- Not relevant
- Control animals:
- no
- Remarks:
- not relevant
- Details on study design:
- DOSE PREPARATION
- Method for preparation of dose suspensions: Mix active and non-labeled material to reach the activity of 1-5 uCi/5 cm2 skin site
VEHICLE
- Amount(s) applied (volume or weight with unit): 30 ul on 5 cm2
- Concentration (if solution): 2.5% (TWEEN-20) and 10% (NEOBEE-M-5)
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 6 hours
ANALYSIS
- Method type(s) for identification: Liquid scintillation counting - Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Source of skin: Naked rat
- Preparative technique:
Fresh operation material is used. Connective and adipose tissue is removed. Round flaps of 20 cm2 are formed, which are cleaned under floating water.
Skin is marked with 5 cm2 stamps and 30 ul of the test material is applied regularly with a micropipette on the marked areas. Then skin is placed in the penetration chamber: lower part is in contact with physiological salt solution, slightly moved by a magnetic stirrer throughout the whole experiment.
- Storage conditions: -20 degrees Celsius in aluminium foil
PRINCIPLES OF ASSAY
- Diffusion cell: Two bell jars between which the skin is tightened
- Receptor fluid: Physiological saline
- Test temperature: 32 degrees Celsius
- Occlusion: Closed system
Results and discussion
- Signs and symptoms of toxicity:
- not examined
- Remarks:
- not relevant
- Dermal irritation:
- not examined
- Remarks:
- not relevant
- Absorption in different matrices:
- - Skin test site:
In TWEEN-20: 130.83 ug/cm2
In NEOBEE-M-5: 546.41 ug/cm2
- Receptor fluid, receptor chamber, donor chamber (in vitro test system):
In TWEEN-20: 0.17 ug/cm2
In NEOBEE-M-5: 2.67 ug/cm2
- Skin preparation (in vitro test system)
Remaining skin tissue layers:
In TWEEN-20: 17.56 ug/cm2
In NEOBEE-M-5: 44.84 ug/cm2
- Stratum corneum (in vitro test system):
In TWEEN-20: 1.44 ug/cm2
In NEOBEE-M-5: 6.08 ug/cm2 - Total recovery:
- - Total recovery: 100%
- Recovery of applied dose acceptable: Yes
Percutaneous absorptionopen allclose all
- Dose:
- 2.5% in TWEEN-20
- Parameter:
- percentage
- Absorption:
- 12.8 %
- Remarks on result:
- other: 6 hours
- Remarks:
- Based on amount in stratum corneum, remaining skin tissue layers and chamber liquid
- Dose:
- 10% in NEOBEE-M-5
- Parameter:
- percentage
- Absorption:
- 8.9 %
- Remarks on result:
- other: 6 hours
- Remarks:
- Based on amount in stratum corneum, remaining skin tissue layers and chamber liquid
- Conversion factor human vs. animal skin:
- No data
Any other information on results incl. tables
Vitamin-A-acetate does penetrate into and through the animal skin.
The penetration rates determined on naked rat skin are about 5-times higher than those found for pig skin.
Applicant's summary and conclusion
- Conclusions:
- Under the current test conditions, the in vitro skin penetration rates of vitamin-A-acetate in naked rat skin were 12.8% and 8.9% in TWEEN-20 and NEOBEE-M-5 respectively, after 6 hours of exposure.
- Executive summary:
Skin penetration rate for Vitamin-A-Acetate labelled with 14C was determined in naked rat and pig skin. Test solution (test substance in TWEEN-20 or NEOBEE-M-5) was applied for 6 hours.
Penetration rates in rat were respectively 12.8 and 8.9%. For pig these were 2.2 and 1.8% respectively.
The authors conclude that the skin penetration rates determined in these "in vitro" studies with Vitamin-A-Acetate on naked rat and pig skin are more concentrationand animal-species-dependent than vehicle-type-dependent. As expected the penetration rates determined on naked rat skin are about 5-times higher than those found for pig skin.
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