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EC number: 612-107-5 | CAS number: 61259-48-1
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2008-09-03 to 2008-09-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented study performed according to OECD guideline 423 and EU method B.1 tris, in compliance with GLP. No deviations were noted.
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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- (2R,3R,4S,5R)-2-(acetoxymethyl)-6-oxotetrahydro-2H-pyran-3,4,5-triyl triacetate
- Cas Number:
- 61259-48-1
- Molecular formula:
- C14H18O10
- IUPAC Name:
- (2R,3R,4S,5R)-2-(acetoxymethyl)-6-oxotetrahydro-2H-pyran-3,4,5-triyl triacetate
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): RT003186
- Substance type: no data
- Physical state: solid
- Analytical purity: 90%
- Impurities (identity and concentrations): no data
- Purity test date: no data
- Lot/batch No.: PFA 011
- Expiration date of the lot/batch: 2010-02-27 (retest date)
- Stability under test conditions: unknown in PEG 300; is excluded from the statement of compliance.
- Storage condition of test material: at room temperature (range of 20 +/- 5°C), light protected. Contact with water will be avoided.
-Stability of test item: stable under storage conditions
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: 6 female rats, HanRcc: WIST (SPF) from RCC Ltd, Laboratory Animal Services
- Age when treated: 11 weeks
- Weight when treated: 187.1 g - 202.1 g
- Fasting period before study: 17 to 17 1/2 hours prior to dosing, access to water was permitted. Food was provided again approx 3 hrs after dosing
- Housing: Standard Laboratory Conditions, in groups of three in Makrolon type-4 cages with wire-mesh tops and standard softwood bedding
- Diet (e.g. ad libitum): ad libitum, standard pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet
- Water (e.g. ad libitum): ad libitum, community tap water from Füllinsdorf
- Acclimation period: 6 days, under laboratory conditions, after health examinations. Only animals without any visible signs of illnes were used for the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12, automatically controlled, music during the daytime light period
IN-LIFE DATES: From: 2008-09-10 To: 2008-09-26
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/ml
- Amount of vehicle (if gavage): 10 ml/kg body weight
- Justification for choice of vehicle: the vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date.
- Lot/batch no. (if required): 1349048
- Purity: no data
- Source: FLUKA Chemie GmbH, CH-9471 Buchs
- Stability of the vehicle: Stable under storage conditions
- Storage conditions: at room temperature (20 +/- 5°C), light protected
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg body weight
DOSAGE PREPARATION (if unusual):
- The dose formulations were made shortly before each dosing occasion using a magnetic stirrer and a spatula as homogenizers. The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weight:volume). Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer.
- Dose levels are in terms of the test item as supplied by the sponsor.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no data - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 females per group; 2 groups
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality/viability: daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15; body weights: on test days 1 (prior to administration), 8 and 15; clinical signs: daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. All abnormalities were recorded.
- Necropsy of survivors performed: yes, all animals were killed at the end of the observation period by carbon dioxide asphyxiation and discarded after macroscopic examinations were performed. No organs or tissues were retained. - Statistics:
- No statistical analysis was used.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- All animals showed ruffled fur at the 1- or 2-hour reading up to 5 hours after treatment, or up to test day 2. Hunched posture was noted in all animals 1 or 2 hours after treatment up to 5-hour reading or up to test day 2.
- Body weight:
- The body weight of the animals was within the range commonly recorded for this strain and ages.
- Gross pathology:
- No macroscopic findings were recorded at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median lethal dose of RT003186 after single oral administration to female rats, observed over a period of 14 days is:
LD50 (female rat): greater than 2000 mg/kg body weight.
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