Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- Endpoint:
- toxicity to reproduction
- Data waiving:
- exposure considerations
- Justification for data waiving:
- other:
- Reproductive effects observed:
- not specified
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
- Species:
- other: human
- Quality of whole database:
- Cholesterol metabolism and adverse effects of high cholesterol intake/disturbed cholesterol regulation has been studied intensively for many years, not only in laboratory animals but also in humans.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Cholesterol metabolism and adverse effects of high cholesterol intake/disturbed cholesterol regulation has been studied intensively for many years, not only in laboratory animals but also in humans. Reported adverse effects related to increased cholesterol levels/disturbed cholesterol metabolism concern mainly cardiovascular effects. In addition, as the liver plays a key role in cholesterol metabolism, liver is considered as target organ for cholesterol. Cholesterol-related effects on the liver are considered a sensitive parameter for toxicity, as these effects (resulting in disturbed cholesterol metabolism) occur before other adverse effects become effective. No effects on reproduction has been reported, indicating that increased cholesterol levels/exposure does not result in reproduction toxicity at relevant exposure levels. It is therefore considered, that limit values for cholesterol exposure based on liver effects are protective for reproductive toxicity as well.
Short description of key information:
All available information on cholesterol.
Effects on developmental toxicity
Description of key information
High doses cholesterol administration by injection to pregnant rats has been used in the past (1964-1972) as an experimental model to study palate malformations . In rats daily injections of 5, 10, 15 or 20 mg cholesterol during days 8-14 of pregnancy resulted in increased numbers of pups with palate abnormalities. In a rat study with daily 6 mg/day cholesterol injections during 8 day in mid-pregnancy did not show pups with palate abnormalities. In rabbits, cholesterol induced developmental toxicty including palate malformations, was observed after high oral cholestrol exposure (250, 500 or 1000 mg/day) via feed.
There was no clear dose-relationship observed in plasma cholesterol levels of the females (rat and rabbit).
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEL
- 250 mg/kg bw/day
- Study duration:
- subacute
- Species:
- other: rat, rabbit
- Quality of whole database:
- reliable
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Daily injections of pregnant rats with high doses cholesterol (5 to 20 mg/day) during days 8 -14 of pregnancy resulted in increased number of pups with abnormal palates. However, this route of exposure is not relevant for human exposure, and needs to be considered as extremely worst case. Moreover, the tested doses of 5 to 20 mg cholesterol per day are considered as very high doses (human equivalent doses of 467 to 1868 mg/day, additionally cholesterol, based on 60% oral absorption and human equivalent dose (HED = rat dose * 0.16).
Also the rabbit study (1972) was performed with very high daily doses in the feed: 250 to 1000 mg/day (HED = rabbit dose * 0.32, resulting in 5600 to 22400 mg/d).
Although cholesterol has been studied intensively for adverse effects, more recent studies on developmental toxicity are not present in the open literature, indicating that the observed developmmental effects observed with very high dose levels are considered not relevant for research on effects related to high/disturbed cholesterol levels. As the developmental effects in rat and rabbit are observed at extremely high dose levels (and by irrelevant exposure route for rat), these effects are considered to be not relevant under more realistic exposure conditions. Moreover, as it is generally known that the liver is considered to be the first target for cholesterol, and limit levels based on adverse effects observed on this target are considered to be protective for developmental effects as well. As the developmental effects in rat and rabbit are observed by exposure to very high doses and a non-relevant route of exposure (rat), it is concluded that these effects are not considered relevant for considering developmental toxicity for human. Consequently, cholesterol needs not te be classified for developmental effects 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.
Justification for selection of Effect on developmental toxicity: via oral route:
Weight of evidence based on all available studies.
Justification for classification or non-classification
Based on all available information on cholesterol in animal studies and human studies, no relevant reproductive or developmental toxicity for humans has been observed/reported. Based on these observations, cholesterol needs not to be classified for reproductive and developmental toxicity 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
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.