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Diss Factsheets
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EC number: 935-211-5 | 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:
- 2011-03-25 - 2011-04-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (GLP)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- Adopted on December 17, 2001
- Deviations:
- yes
- Remarks:
- Starting dose at 500 mg/kg bw
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- Adopted in December 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nosan No. 8147
- Deviations:
- yes
- Remarks:
- as this in line with OECD 423.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 1,4:3,6-dianhydro-2,5-bis-O-(diphenoxyphosphoryl)-D-glucitol
- EC Number:
- 935-211-5
- Cas Number:
- 1305113-15-8
- Molecular formula:
- C30H28O10P2
- IUPAC Name:
- 1,4:3,6-dianhydro-2,5-bis-O-(diphenoxyphosphoryl)-D-glucitol
- Details on test material:
- - Name of test material (as cited in study report): Isosorbid-O,O'-bis(diphenylphosphorsäureester); Lab test item number: 10/0230-4
- Physical state: solid / white
- Analytical purity: 98.5 mol% (NMR-spectroscopy)
- Lot/batch No.: 10264/10/022 B
- Stability under test conditions: the stability under storage conditions over the study period was guaranteed by the sponsor.
- Storage condition of test material: room temperature
- Other: the test item was homogeneous by visual inspection.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Wistar / Crl:WI (Han) SPF rats from Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany.
- Age at study initiation: young adult (approx. 10-11 weeks) nulliparaus and non-pregnant female animals. As suggested by the OECD guideline female animals were used for the test, because there is no indication that male animals are likely to be more sensitive to the acute effects of the test item.
- Weight at study initiation: see Table 1; animals of comparable weight (± 20% of the mean weight) were used.
- Fasting period before study: feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: single housing in Makrolon cage, type 111
- Diet (ad libitum): VRF1 (P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water (ad libitum): tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Remarks:
- Olive oil Ph.Eur.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 40 g/100 ml in the 2000 mg/kg dose group and 10 g/100 ml in the 500 mg/kg dose group.
- Amount of vehicle (if gavage): 5 ml/kg bw (test substance suspension in vehicle).
- Justification for choice of vehicle: good homogeneity of test substance suspension.
MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: by the request of the sponsor a starting dose of 500 mg/kg bw was chosen in the first step. - Doses:
- 500 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 3; 3 female animals were use at the first step and received 500 mg/kg bw test substance in vehicle. As no mortality occurred, 2000 mg/kg bw were administered to 3 additional female rats in the second step. Because no mortality occurred in the second step, 2000 mg/kg bw were administered to another group of 3 female animals in the third step. Because no mortality occurred again the study was terminated
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals. Determination of individual body weights shortly before administration (day 0), weekly thereafter, and on the last day of observation. A check for any dead or moribund animals made at least once each workday.
- Necropsy of survivors performed: yes; necropsy with gross-pathology examination on the last day of the observation period after sacrifice with CO2 in a chamber with increasing concentrations over time. - Statistics:
- The mean body weights were calculated in each treatment group.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Interpretation of the results based on the Annex 2 of the OECD TG 423; No mortality occurred and no signs of systemic toxicity were observed up to 2000 mg/kg bw.
- Mortality:
- No mortality occurred (2000 mg/kg: 6 females evaluated; 500 mg/kg bw 3 females evaluated).
- Clinical signs:
- No clinical signs were observed during clinical examination.
- Body weight:
- The mean body weight of the test groups increased throughout the study period within the normal range (see Table 1)
- Gross pathology:
- There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.
Any other information on results incl. tables
Table 1: Body weight change
Study day |
Mean body weights ± standard deviations at indicated dose levels |
||
2000 mg/kg bw |
500 mg/kg bw |
||
Second step |
Third step |
First step |
|
0 |
188.0±3.46 |
182.0±2.00 |
183.3±2.31 |
7 |
203.0±4.36 |
199.7±4.16 |
201.7±6.43 |
14 |
211.7±2.52 |
205.0±5.29 |
205.0±4.00 |
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.