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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 9 - 19, 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- 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:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Robinson Services, Inc. Clemmons, NC on June 25, 2008
- Age at study initiation: Young adult
- Weight at study initiation: 2280 - 2426 grams
- Housing: singly housed in suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals DHEW (NIH). Litter paper was placed beneath the cage and was changed at least three times per week
- Diet (e.g. ad libitum): Purina Certified High Fiber Rabbit Diet (PMI #5325) ad libitum
- Water (e.g. ad libitum): Filtered tap water was supplied ad-libitum by an automatic water dispensing system
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 68-86%
- Air changes (per hr): 20
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
IN-LIFE DATES: From: July 9, 2008 To: July 19, 2008
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipping the dorsal area and the trunk
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Five-tenths of a milliliter of the test substance was applied to one 6-cm2 intact dose site on each animal (and covered with a 1-inch x 1-inch, 4-ply
gauze pad. The pad and entire trunk of each animal were then wrapped with semi-occlusive 3-inch Micropore tape to avoid dislocation of the pad). - Duration of treatment / exposure:
- After 4 hours of exposure to the test substance, the pads and collars were removed and the test sites were gently cleansed of any residual test
substance. - Observation period:
- Individual dose sites were scored according to the Draize scoring system at approximately 30-60 minutes, 24, 48, and 72 hours and at 7 and 10
days after patch removal. - Number of animals:
- Three (3)
- Details on study design:
- In addition to the above details:
Body Weights
Individual body weights of the animals were recorded prior to test substance application (initial) and again at study termination after scoring.
Cage-Side Observations
The animals were observed for signs of gross toxicity and behavioral changes at least once daily during the test period. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea, and coma.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- Draize scoring system
- Basis:
- mean
- Remarks:
- 2.0, 1.3, 1.3, 1.3, 0.7, 0
- Time point:
- other: 60 min, 24h, 48h, 72h, 7d, 10d
- Score:
- >= 0 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 - 10 days
- Irritation parameter:
- edema score
- Remarks:
- Draize scoring system
- Basis:
- mean
- Remarks:
- 2.0, 0.3, 0.3, 0.3, 0.3, 0
- Time point:
- other: 60 min, 24h, 48h, 72h, 7d, 10d
- Score:
- >= 0 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 - 10 days
- Irritant / corrosive response data:
- Within one hour after patch removal, all three treated sites exhibited well-defined erythema and slight edema. Although the overall incidence and
severity of irritation decreased gradually with time, dermal desquamation was observed for two animals on Day 10 (study termination). - Other effects:
- All animals gained body weight and appeared active and healthy during the study. Apart from the skin irritation noted below, there were no other
signs of gross toxicity, adverse clinical signs, or abnormal behavior.
Any other information on results incl. tables
Time after patch removal | |||||||
Anaimal No. | Sex | 30-60 min | 24 hrs | 48 hrs | 72 hrs | day 7 | day 10 |
3501 | F | 2/2 | 2/1 | 2/1 | 1/1 | 1/1 | 0/0 |
3502 | F | 2/2 | 1/0 | 1/0 | 1/0 | 1/0 | 0/0 |
3503 | F | 2/2 | 1/0 | 1/0 | 1/0 | 0/0 | 0/0 |
Total | 6/6 | 4/1 | 4/1 | 4/1 | 2/1 | 0/0 | |
Mean | 2.0/2.0 | 1.3/0.3 | 1.3/0.3 | 1.3/0.3 | 0.7/0.3 | 0/0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, Methyl (Polyhydroxymethyl) Stearate caused well-defined erythema and slight edema. Dermal desquamation
was observed for two animals on Day 10 (study termination). The inflammation was not perceived as significant as the mean values for erythema and edema were not equal to 2 (or more) by the 24 hour time point, or for at least two animals separately. Per Annex VI of the Dangerous Substances
Directive, this material should not be classified as irritating. - Executive summary:
A primary skin irritation test was conducted with New Zealand albino rabbits to determine the potential for Methyl (Polyhydroxymethyl) Stearate to produce irritation after a single topical application. Under the conditions of this study, the test substance caused well-defined erythema and slight edema. Dermal desquamation occurred for two animals on Day 10 (study termination).
Five-tenths of a milliliter of the test substance was applied to the skin of three healthy rabbits for 4 hours. Following exposure, dermal irritation was evaluated by the method of Draize. Within one hour after patch removal, all three treated sites exhibited well-defined erythema and slight edema. Although the overall incidence and severity of irritation decreased gradually with time, dermal desquamation occurred for two animals on Day 10 (study termination).
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.
Παρόλο που ο Οργανισμός παρέχει μεγάλο μέρος του διαδικτυακού περιεχομένου στη γλώσσα σας, ένα μέρος αυτής της σελίδας είναι μόνο στα αγγλικά. Περαιτέρω πληροφορίες για την πολύγλωσση πρακτική του ECHA.
Καλώς ήρθατε στον δικτυακό τόπο του ECHA. Η παρούσα ιστοθέση δεν υποστηρίζεται πλήρως από τον Internet Explorer 7 (ή προγενέστερες εκδόσεις). Αναβαθμίστε τον φυλλομετρητή σας Internet Explorer σε πιο πρόσφατη έκδοση.
Ο παρών ιστότοπος χρησιμοποιεί cookies για να διασφαλίζεται ότι αποκομίζετε την καλύτερη δυνατή εμπειρία από την περιήγησή σας στους ιστοτόπους μας.
Μάθετε περισσότερα σχετικά με τον τρόπο που χρησιμοποιούμε τα cookies.