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EC number: 205-471-8 | CAS number: 141-23-1
- 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
- Endpoint:
- carcinogenicity, other
- Remarks:
- subcutaneous injections
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- The data is from a peer-reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Investigation of Fatty Acids and Derivatives for Carcinogenic Activity
- Author:
- D. Swern, R. Wieder, M. McDonough, D. R. Meranze, and M. B. Shimkin
- Year:
- 1 970
- Bibliographic source:
- CANCER RESEARCH 1970, 30:1037-1046
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: see Principles below
- Principles of method if other than guideline:
- A study of Methyl 12-hydroxystearate was conducted in mice to investigate the carcinogenic activity.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Methyl 12-hydroxyoctadecanoate
- EC Number:
- 205-471-8
- EC Name:
- Methyl 12-hydroxyoctadecanoate
- Cas Number:
- 141-23-1
- Molecular formula:
- C19H38O3
- IUPAC Name:
- methyl 12-hydroxyoctadecanoate
- Test material form:
- solid
- Details on test material:
- - Name of the test material: Methyl 12-hydroxyoctadecanoate- IUPAC name: Methyl 12-hydroxyoctadecanoate- Molecular formula: C19H38O3- Molecular weight: 314.5062 g/mol- Substance type: Organic- Smiles: C(CCCCCCCCCCC(=O)OC)(CCCCCC)O- Inchl: 1S/C19H38O3/c1-3-4-5-12-15-18(20)16-13-10-8-6-7-9-11-14-17-19(21)22-2/h18,20H,3-17H2,1-2H3
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Swiss-Webster
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Carworth Inc., (New York, NY)- Age at study initiation: 2 months - Weight at study initiation: No data available- Fasting period before study: No data available- Housing: Mice were housed in groups of 8 in plastic shoe-box type cages in air-conditioned quarters with heat-treated absorbent cedar cubed wood as bedding in a controlled environment. - Diet (e.g. ad libitum): Teklad mouse diet pellets, ad libitum.- Water (e.g. ad libitum): Water, ad libitum- Acclimation period: One weekENVIRONMENTAL CONDITIONS- Temperature (°C): No data available- Humidity (%): No data available.- Air changes (per hr): No data available- Photoperiod (hrs dark / hrs light): No data available
Administration / exposure
- Route of administration:
- subcutaneous
- Vehicle:
- other: Tricaprylin
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The test chemical was dissolved in tricaprylin prior to dosing. DIET PREPARATION- Rate of preparation of diet (frequency): No data available- Mixing appropriate amounts with (Type of food): No data available - Storage temperature of food: No data availableVEHICLE- Justification for use and choice of vehicle (if other than water): Tricaprylin- Concentration in vehicle: 0, 0.5 or 5 mg- Amount of vehicle (if gavage): No data available- Lot/batch no. (if required): No data available- Purity: No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 40 weeks
- Frequency of treatment:
- Twice per week
- Post exposure period:
- 14 months (from week 41 and onwards until sacrifice in month 24)
Doses / concentrations
- Remarks:
- Doses/Concentrations: 0, 0.5 or 5 mg
- No. of animals per sex per dose:
- Total: 45 miceControl: 15 females0.5 mg: 15 females5 mg: 15 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes- Time schedule: No data available- Cage side observations included: Mortality was observed. DETAILED CLINICAL OBSERVATIONS: Yes- - Time schedule: Twice weeklyBODY WEIGHT: Yes - Time schedule for examinations: All mice were weighed at the start of the experiments and at regular intervals throughout the ensuing period of observation of 18 to 24 months.FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data availableFOOD EFFICIENCY: No data availableWATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data availableOPHTHALMOSCOPIC EXAMINATION: No data availableHAEMATOLOGY: No data availableCLINICAL CHEMISTRY: No data availableURINALYSIS: No data availableNEUROBEHAVIOURAL EXAMINATION: No data availableOTHER: No data available
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes Animals with tumors or those in poor condition were killed and autopsied. Suspected neoplasms and other grossly abnormal tissues were removed and fixed.HISTOPATHOLOGY YesAll diagnoses were based on histological examination of sections stained with hematoxylin and eosin.
- Other examinations:
- No data available
- Statistics:
- No data available
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- At 18 months, 6 out of 15 female mice treated with 0.5 mg of the target compound was alive, while 12 females were alive in the 5.0 mg-exposed group. At 6 months, 27 female mice out of 30 treated mice were alive.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No excessive weight losses or gains were found as compared with untreated control groups.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Methyl 12-hydroxystearate produced sarcomas in 8 of 27 mice.
- Other effects:
- not specified
- Relevance of carcinogenic effects / potential:
- Since Methyl 12-hydroxystearate produced sarcomas in 8 of 27 mice, the target chemical is classified as tentatively carcinogenic.
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 0.5 other: mg
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- histopathology: neoplastic
- mortality
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- LOAEL was found to be 0.5 mg when female Swiss-Webster mice were exposed with Methyl 12-hydroxystearate by subcutaneous injection.
- Executive summary:
A carcinogenic toxicity study of Methyl 12-hydroxystearate was performed in female Swiss-Webster mice. The mice were exposed to the target chemical at a dosage of 0, 0.5 or 5 mg by subcutaneous injection 2 times per week for 40 weeks. All mice were weighed at the start of the experiments and at regular intervals throughout the period of observation of 18 to 24 months (i.e. during the post exposure period). Mice were observed for the appearance of subcutaneous tumors where animals with tumors or those in poor condition were killed and autopsied. Suspected neoplasms and other grossly abnormal tissues were removed and fixed prior to histological examination. No excessive weight losses or gains were found as compared with untreated control groups. At 18 months, 6 out of 15 female mice treated with 0.5 mg of the target compound was alive, while 12 females were alive in the 5.0 mg-exposed group. In addition, Methyl 12-hydroxystearate produced sarcomas in 8 of 27 mice and is thus classified as tentatively carcinogenic. Hence, LOAEL was found to be 0.5 mg when female Swiss-Webster mice were exposed with Methyl 12-hydroxystearate by subcutaneous injection.
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