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Diss Factsheets
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EC number: 247-569-3 | CAS number: 26266-58-0
- 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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Anhydro-D-glucitol trioleate
- EC Number:
- 247-569-3
- EC Name:
- Anhydro-D-glucitol trioleate
- Cas Number:
- 26266-58-0
- Molecular formula:
- C60H108O8
- IUPAC Name:
- 1,4-anhydro-2,3,6-tri-O-oleoyl-L-iditol
- Details on test material:
- - Name of test material (as cited in study report): anhydro-D-glucitol trioleate
- Physical state: amber coloured liquid
- Analytical purity: no data
- Storage condition of test material: at room temperature in the dark
- Other: total ester content 86.8%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: RccHan:WIST
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Oxon, UK
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 200 - 350 g
- Housing: groups of three by sex in solid-floor polypropylene cages with stainless steel lids, furnished with softwood flakes and provided with environmental enrichment items: wooden chew blocks and cardboard "fun tunnels"
- Diet (ad libitum): Harlan 2014C Rodent Diet
- Water (ad libitum): mains drinking water
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30- 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume: cylindrical exposure chamber (30 m³)
- Method of holding animals in test chamber: each rat was individually held in a tapered, polycarbonate restraining tube fitted onto a single tier of the exposure chamber and sealed by means of a rubber "O" ring.
- Method of conditioning air: compressed air was supplied by means of an oil free compressor and passed through a water trap and respiratory quality filters before it was introduced to the nebuliser. The concentration within the exposure chamber was controlled by adjusting the rate of the infusion pump. The extract from the exposure chamber passed through a "scrubber" trap and was connected with a high efficiency filter to a metered exhaust system. The chamber was maintained under negative pressure. The chamber flow rate was maintained at 60 L/min providing 120 air changes per hour.
- System of generating particulates/aerosols: The test item was aerosolised using a glass concentric jet nebuliser located at the top of the exposure chamber. The nebuliser was connected to a plastic syringe attached to an infusion pump, which provided a continuous supply of test item under pressure, and to a metered compressed air supply.
- Method of particle size determination: The particle size of the generated atmosphere inside the exposure chamber was determined three times during the exposure period using a Marple Personal Cascade Impactor.
- Temperature, humidity: 20°C, 72-76% (at least 19% oxygen)
TEST ATMOSPHERE
- Brief description of analytical method used: the test atmosphere was sampled at regular intervals during the exposure period. A weighed glass fibre filter was placed in a filter holder and temporarily sealed in a vacant port of the exposure chamber in the animals´ breathing zone. A known quantity of the exposure chamber atmosphere was drawn through the filter using a vaccum pump. After sampling, the filter was dried, under similar conditions as those previously described, and weighed again 24 h later. The difference in the pre and post sampling weights, divided by the volume of atmosphere sampled, was the chamber concentration in terms of non-volatile component.
- Samples taken from breathing zone: yes
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: inhalable fraction (< 4 µm) of 73.8%
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 2.14 µm / 2.68 µm - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5.27 ± 0.41 mg/L (analytical concentration)
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed hourly during exposure, immediately on removal from the restraining tubes at the end of the exposure, 1 h after termination of exposure and subsequently once daily for the remaining 14 days. Individual bodyweights were recorded on arrival, prior to treatment on the day of exposure and on Days 1, 3, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.27 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: Common abnormalities noted during the study included increased respiratory rate, hunched posture, piloerection, red/brown staining around the snout and wet fur. The animals recovered to appear normal from Days 3 to 5 post-exposure.
- Body weight:
- All animals exhibited bodyweight losses on the first day post-exposure. Reasonable bodyweight development was noted in all male animals during the recovery period. In contrast, one female animal exhibited a further bodyweight loss from Days 1 to 3 post-exposure, two females showed either a slight bodyweight loss or no bodyweight gain from Days 3 to 7 post-exposure. Reasonable bodyweight development was noted in all female animals during the final week of recovery (see Table 1).
- Gross pathology:
- Necropsy examination revealed no substance-related findings.
Any other information on results incl. tables
Table 1: Individual body weights
|
Bodyweight (g) on Day: |
|||||
Animal number and sex |
-8 |
0 |
1 |
3 |
7 |
14 |
1 male |
218 |
253 |
247 |
258 |
269 |
287 |
2 male |
236 |
275 |
266 |
281 |
292 |
317 |
3 male |
217 |
275 |
271 |
284 |
292 |
326 |
4 female |
188 |
200 |
198 |
204 |
204 |
211 |
5 female |
222 |
251 |
248 |
240 |
235 |
246 |
6 female |
218 |
233 |
232 |
240 |
245 |
253 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DSD: not classified
CLP: not classified
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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