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EC number: 200-353-2 | CAS number: 57-88-5
- 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

Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July-October 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Cholesterol
- EC Number:
- 200-353-2
- EC Name:
- Cholesterol
- Cas Number:
- 57-88-5
- Molecular formula:
- C27H46O
- IUPAC Name:
- cholest-5-en-3-ol
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): cholesterol
- Physical state: white powder
- Storage condition of test material: at room temperature in the dark
Constituent 1
Test animals
- Species:
- other: human epidermis model (human-derived epidermal keratinocytes)
- Details on test animals or test system and environmental conditions:
- test system:
three-dimensional human epidermis model, consisting of adult human-derived epidermal keratinocytes, seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. The keratinocytes were cultured for 13 days, resulting in a highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.
source:
SkinEthic Laboratories, Lyon, France.
Test system
- Type of coverage:
- other: in vitro system
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume or weight with unit): 10.2 to 11.5 mg cholesterol. - Duration of treatment / exposure:
- 15 minutes at room temperature, post-incubation for 42 hours at 37°C.
- Details on study design:
- Cytotoxicity (irritancy) is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of treatment.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: cytotoxicity
- Value:
- 102
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 15 minutes exposure. Reversibility: other: not relevant. Remarks: in vitro study. (migrated information)
In vivo
- Irritant / corrosive response data:
- mean tissue viability:
negative control: 100%
cholesterol: 102%
pos control: 5%
Any other information on results incl. tables
acceptability of the assay.
the test is considered acceptable if it meets the following criteria:
-the absolute mean optical density at 570 nm of the three tissues of the negative control should reasonably be within the laboratory historical control data range and the SD value of the % viability should be ≤18
-the mean relative tissue viability of the positive control should be ≤40% relative to the negative control and the SD value of the % should be ≤18
-the SD calculated from individual % tissue viabilities of the three identically treated replicates should be ≤18
A test substance is considered irritant in the skin irritation test if:
The relative mean tissue viability of three individual tissues after 15 minutes of exposure to the test substance and 42 hors of post-incubation is ≤50% of the mean viability of the negative controls.
A test substance is concidered non-irritant in the skin irritation test if:
The relative mean tissue viability of three individual tissues after 15 minutes of exposure to the test substance and 42 hours of post incubation >50% of the mean viability of teh negative controls.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Cholesterol is non-irritant in a valid in vitro skin irritation test.
- Executive summary:
Cholesterol was tested for skin irritaing potential with a human three dimensional epidermal model (EPISKIN-Small Model). 10.2 to 11.5 mg cholesterol was applied directly on top of the skin tissue for 15 minutes, and after a 42 hours post-incubation period the cytotoxic effect (as indicator for irritancy) was determined by means of the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT. Mean relative tissue viability above 50% is considered non-irritant. Adequate positive and negative controls were included. The relative mean tissue viability after treatment with cholesterol compared to the negative control tissue was 102%. Based on these results, cholesterol is considered non-irritant in this in vitro test.
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