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Diss Factsheets
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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
Carcinogenicity
Administrative data
Description of key information
Two evaluations performed by WHO-IARC.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity
- Remarks:
- other: Oral (animal studies and human studies. In addition from animal studies information on subcutaeous administration and bladder implantation has been evaluated.
- Type of information:
- other: IARC monograph
- Adequacy of study:
- key study
- Study period:
- until October 1975
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Evaluation of available information on carcinogenicity potential of cholesterol by WHO-IARC, a well-established organisation for cancer research.
- Principles of method if other than guideline:
- Overall evaluation of carcinogenic potential of cholesterol by the WHO-IARC.
- Species:
- other: information on laboratory animals as well as human information
- Sex:
- male/female
- Route of administration:
- other: Oral (animal studies and human studies. In addition from animal studies information on subcutaeous administration and bladder implantation has been evaluated.
- Details on exposure:
- variable exposure duration and exposure conditions in the various animal and human studies.
- Duration of treatment / exposure:
- variable in the various animal and human studies
- Frequency of treatment:
- variable in the various studies
- Details on results:
- Cholesterol was tested for carcinogenicity in mice by administration in the diet, by subcutaneous administration and by bladder implantation. These studies were all inadequate for evaluation. Cholesterol has also been tested in combination with various carcinogens, but the results were inadequate to assess the carcinogenesis-enhancing potential of the compound. Feeding of cholesterol to rats exposed to a mammary carcinogen did not affect the incidence of mammary tumours, while feeding after administartion of a colon carcinogen resulted in a lower incidence of colon tumours. No data were available on the genetic and related effects on cholesterol in humans. It did not transform Syrian hmaster embryo cells and was not mutagenic in bacteria.
- Dose descriptor:
- other: overall evidence
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: There is no adequate evidence for cholesterol for carcinogenicity to humans.
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Conclusions:
- In the IARC monograph it is concluded that cholesterol is not classifiable as to its carcinogenicity to humans, as the evidence for carcinogencity to humans is considered inadequate. Topics that are selected for the IARC monogaphs programme on the evaluation of carcinogenic risks to human concern agents for which there is evidence of human exposure and there is some evidence or suspicion of carcinogenicity. Since 1987, cholesterol has not been re-evaluated by IARC for carcinogenic potential. It can be concluded that since 1987, no significant data on cholesterol has become available which resulted in re-evaluation and revision of the monography. Consequently, there is no adequate evidence for cholesterol for carcinogenicity to humans.
- Executive summary:
Cholesterol was evaluated for its carcinogenic potential by IARC in 1976. Based on the available animal carcinogenicity data, IARC concluded that no assessment was possible, due to the absence of adequate feeding studies and the use of various vehicles and variation in parameters unrelated to the dose of cholesterol in the subcutaneous injection studies. Implantation expoerminets using cholesterol were considered difficult to interpret, as the effects of teh physical factors must be taken into consideration.
In 1987 cholesterol was re-evaluated by IARC. For this re-evaluation, animal studies as well as evidence for carcinogenicity to humans was evaluated. In the IARC monograph it is concluded that cholesterol is not classifiable as to its carcinogenicity to humans, as the evidence for carcinogencity to humans is considered inadequate. Topics that are selected for the IARC monogaphs programme on the evaluation of carcinogenic risks to human concern agents for which there is evidence of human exposure and there is some evidence or suspicion of carcinogenicity. Since 1987, cholesterol has not been re-evaluated by IARC for carcinogenic potential. It can be concluded that since 1987, no significant data on cholesterol has become available which resulted in re-evaluation and revision of the monography. Consequently, there is no adequate evidence for cholesterol for carcinogenicity to humans.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Species:
- other: animals and humans
Justification for classification or non-classification
Based on the absence of evidence of cholesterol-related carcinogenicity, cholesterol is not considered carcinogenic, and consequently needs not to be classified for carcinogenicity according to:
-Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011),
-Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures
Additional information
Cholesterol has no genotoxic properties, as demonstrated in several studies from the open literature. Moreover, increased cholesterol levels related to carcinogenicity has been studied intensively, and has been evaluated by the IARC. Based on both data from animal studies and data from human epidemiological studies, no relationship between high cholesterol levels and carcinogenicity could be demonstrated. In the absence of evidence of cholesterol-related carcinogenicity, cholesterol is not considered as carcinogenic.
Justification for selection of carcinogenicity via oral route endpoint:
evaluation of all available information by IARC
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.
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