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Diss Factsheets
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EC number: 947-474-3 | 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented publication, similar to guideline, a parallel satellite group was used in this combined chronic/carcinogenetic study to determine chronic effects.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- Deviations:
- no
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- α-d-Glucopyranoside, β-d-fructofuranosyl, octadecanoate
- EC Number:
- 253-459-6
- EC Name:
- α-d-Glucopyranoside, β-d-fructofuranosyl, octadecanoate
- Cas Number:
- 37318-31-3
- Molecular formula:
- C18 H36 O2 . x C12 H22 O11
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344/DuCrj
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan Inc.
- Age at study initiation: 5 weeks old at the start of treatment
- Housing: Polycarbonate cages with hardwood chip bedding were used, and in each housed two animals.
- Diet: radiation-sterilized powder feed, CRF-1, Oriental Yeast Co., Ltd. ad libitum, replaced weekly, Feed mix was prepared twice during the study.
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 20-25 °C
- Humidity: 40-70 %
- Air changes: 12 changes/h
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: CRF-1
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Animals in groups of 14 rats/sex/group received the test item at 0, 1, 3 or 5 %.
DIET PREPARATION
- Rate of preparation of diet: The feed mix was prepared every 9 weeks.
- Storage temperature of food: Kept in a refrigerated storeroom. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Stability of the test substance in the mix was checked after 3, 10 and 18 weeks by gas chromatographic analysis.
- Duration of treatment / exposure:
- One year
- Frequency of treatment:
- Diet was replaced weekly
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 1, 3 or 5 % equivalent to 394, 1160, 1970 mg/kg bw/day (males) and 480, 1440 and 2440 mg/kg bw/day (females)
Basis:
nominal in diet
- No. of animals per sex per dose:
- Satellite group: 14 rats/sex/group were used
- Control animals:
- yes
- Details on study design:
- - Satellite group was used in this combined chronic/carcinogenetic study to determine chronic effects
Examinations
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Checked daily
BODY WEIGHT: Yes
- Time schedule for examinations: once a week for the first 13 weeks and at least once every 4 weeks thereafter
FOOD CONSUMPTION AND COMPOUND INTAKE:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: Every 3 months and within 1 week before the end of treatment.
- Dose groups that were examined: In all animals before the administration, every 3 months and within 1 week before the end of treatment in the control and high-dose group.
HAEMATOLOGY: Yes
- Time schedule for collection of blood: every 3 month and at the scheduled time of sacrifice.
- Anaesthetic used for blood collection: No from the orbital venous plexus, Yes (sodium pentobarbital) from the inferior vena cava
- Animals fasted: Yes approximately 12 h - Sacrifice and pathology:
- The following organs were weighed: liver, kidneys, adrenals, testes, ovaries, brain, heart, lungs, and spleen.
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes: brain, pituitary, thyroid (with parathyroids), thymus, trachea, lungs (including the bronchi), heart, aorta, salivary glands (submandibular and sublingual), liver, spleen, adrenals, pancreas, testes, epididymides, prostate gland, seminal vesicle, ovaries, uterus, vagina, skin (ventral region), tongue, esophagus, stomach (proventricular and glandular), duodenum, jejunum, ileum, cecum, colon, rectum, kidneys, bladder, lymph nodes (submandibular and mesenteric), mammary gland (female, ventral region), muscle (femoral muscle, either side), sciatic nerve (either side), femur (including the marrow, either side), sternum (including the marrow), eyes (including the optic nerves), Harderian glands (both), spinal cord (cervical, thoracic, and lumbar), and any other organs and tissues with macroscopic changes, nasal cavity, oviducts, auditory sebaceous gland, and extraorbital lacrimal gland. - Statistics:
- Bartlett´s equal variance test
Analysis of variance (ANOVA)
Dunnett´s method
Scheffé´s method
Kruskal-Wallis H test
Amitage´s x^2 test
Fischer exact method
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- BODY WEIGHT AND WEIGHT GAIN: Significant decrease in weight gain in male rats of the high-dose group relative to controls was observed in weeks 3 to 6 and weeks 8, 10 and 17 to 49 after administration.
FOOD CONSUMPTION AND COMPOUND INTAKE: Clearly lower in the first week of administration in males of the high dose group and females of the medium and high dose groups relative to the respective controls.
HAEMATOLOGY: Elevated MCV levels ( mean copuscular volume) relative to controls were observed in females in the satellite groups at 13 weeks (all dose groups) and 39 weeks (5 % group), 78 weeks (5%) and 104 weeks (5 %).
ORGAN WEIGHTS: The relative weight of lungs was increased in females from the high-dose group
GROSS PATHOLOGY: In nonsurviving animals, approximately one-half of the animals in each group had large granular lymphocyte leukemia with associated macroscopic observations such as spleen enlargement and liver surface abnormalities.
The effects described above were judged to be not based on compound related effects. The study demonstrated that the test substance was not toxic in Fischer rats.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 2 440 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No adverse effects were observed
- Dose descriptor:
- NOAEL
- Effect level:
- 1 970 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No adverse effects were observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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.