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EC number: - | CAS number: -
- 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

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 21-Aug 8, 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in accordance with regulatory test guidance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): methyl(polyhydroxymethyl) stearate
- Molecular formula (if other than submission substance): not specified in report
- Molecular weight (if other than submission substance): not specified in report
- Smiles notation (if other than submission substance): not specified in report
- InChl (if other than submission substance): not specified in report
- Structural formula attached as image file (if other than submission substance): not specified in report
- Substance type: mixture of functionalized fatty acid methy esters (FAMEs), which may be derived from a variety of natural seed oils
- Physical state: waxy, cloudy colorless liquid
- Analytical purity: 95.2%
- Impurities (identity and concentrations): not specified in report
- Composition of test material, percentage of components: not specified in report
- Isomers composition: not specified in report
- Purity test date: August 22, 2005
- Lot/batch No.: 200500200-25-4
- Expiration date of the lot/batch: not specified in report
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions: normal ambient conditions
- Storage condition of test material: environmentally controlled facility at ambient conditions
- Other:
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Indianspolis, IN, USA
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 128-135 grams
- Fasting period before study: overnight prior to dosing
- Housing: singly housed in suspended stainless steel caging with mesh floors
- Diet (e.g. ad libitum): Purina Certified Rodent Diet (PMI #5002)
- Water (e.g. ad libitum): Filtered tap water was supplied ad libitum
- Acclimation period: 6-10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21ºC
- Humidity (%): 71-87%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
IN-LIFE DATES: From: July 21, 2008 To: August 8, 2008
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: no vehicle; undiluted test material
- Amount of vehicle (if gavage): no vehicle
- Justification for choice of vehicle: no vehicle
- Lot/batch no. (if required):
- Purity:
MAXIMUM DOSE VOLUME APPLIED: 0.29 mL
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: previous screening data - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- five (5)
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for mortality, signs of gross toxicity, and behavioral changes for the first several hours post-dosing and at least once daily thereafter for 14 days after dosing; body weights of the animals were recorded prior to test substance administration (initial) and again on Days 7 and 14 (termination) following dosing
- Necropsy of survivors performed: yes; gross necropsies were performed at the end of the 14-day observation period
- Other examinations performed: nothing additional - Statistics:
- none specified in report
Results and discussion
- Preliminary study:
- No evidence of toxicity or mortality at dose of 2,000 mg/kg.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- None; all animals survived.
- Clinical signs:
- other: There were no signs of gross toxicity, adverse clinical signs, or abnormal behavior.
- Gross pathology:
- No gross abnormalities were noted for the animals when necropsied at the conclusion of the 14-day observation period.
- Other findings:
- None
Any other information on results incl. tables
Animal | Dose level | Body weight (grams) | Dose | |||
Number | (mg/kg) | Pre-dose | Day 7 | Day 14 | (mL) | |
3101 |
2000 | 135 |
146 | 154 | 0.29 | |
3102 | 2000 | 128 | 137 | 150 | 0.27 | |
3103 | 2000 | 132 | 141 | 154 | 0.28 | |
3104 | 2000 | 130 | 138 | 149 | 0.28 | |
3105 | 2000 | 131 | 139 | 150 | 0.28 |
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information not classified Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the acute oral LD50 of Methyl (Polyhydroxymethyl) Stearate was greater than 2,000 mg/kg of body weight in
female rats. - Executive summary:
An acute oral toxicity test (Up and Down Procedure) was conducted with Fischer 344 rats to determine the potential for Methyl (Polyhydroxymethyl) Stearate to produce toxicity from a single dose via the oral route. Under the conditions of this study, the acute oral LD50 of Methyl (Polyhydroxymethyl) Stearate was greater than 2,000 mg/kg of body weight in female rats. An initial limit dose of 2,000 mg/kg was administered to one healthy female rat by oral gavage. Due to the absence of mortality in this animal, four additional females sequentially received the same dose level. Since these animals survived, no additional animals were tested. Females were selected for the test because they are frequently more sensitive to the toxicity of test compounds than males. All animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for 14 days after dosing. Body weights were recorded prior to administration and again on Days 7 and 14 (termination) following dosing. Necropsies were performed on all animals at sacrifice. All animals survived, gained body weight, and appeared active and healthy during the study. There were no signs of gross toxicity, adverse clinical signs, or abnormal behavior. No gross abnormalities were noted for the animals when necropsied at the conclusion of the 14-day observation period.
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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