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EC number: 701-298-1 | 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:
- 04 July to 19 July 2017.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was a GLP-compliant OECD guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Dialkyl C18 and C18-unsaturated phosphonates
- EC Number:
- 701-298-1
- Cas Number:
- 64051-29-2
- Molecular formula:
- Not applicable for a UVCB Substance
- IUPAC Name:
- Dialkyl C18 and C18-unsaturated phosphonates
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Alkenyl phosphonate
- Expiration date of the lot/batch: 09 September 2017
- Purity test date: 08/06/2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Controlled room temperature (15-25 ºC, below 70 RH%)
- Stability under test conditions: yes
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH.
- Age at study initiation: 10 weeks old
- Weight at study initiation: 225 – 238 g
- Fasting period before study: yes
- Housing: 3 animals / cage (Type II. polypropylene/polycarbonate).
- Food consumption (e.g. ad libitum): ad libitum
- Water consumption (e.g. ad libitum): ad libitum
- Acclimation period: 21-22 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 – 24.3 °C
- Humidity (%): 31 – 70 %
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12hr/12hr
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): BCBS1795V
- Purity: no data - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- DETAILS ON STUDY DESIGN
- Duration of observation period following administration: 14 days
- Frequency of observations: Clinical observations were performed on all animals at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter.
- Frequency of weighing: The body weight was recorded on the day before treatment (Day -1), on the day of the treatment (Day 0) and weekly thereafter.
- Necropsy of survivors performed: yes on day 15
- Other examinations performed: macroscopic examination at necropsy (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organ with obvious abnormalities) - Statistics:
- no data
Results and discussion
- Preliminary study:
- Not applicable.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Alkenyl phosphonate did not cause mortality at a dose level of 2000 mg/kg bw.
- Clinical signs:
- other: There were no systemic clinical signs noted in any animal throughout the study.
- Gross pathology:
- There was no evidence of the macroscopic observations at necropsy at a dose level of 2000 mg/kg bw.
Any other information on results incl. tables
None.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item Alkenyl phosphonate was found to be above 2000 mg/kg bw in female Crl:WI rats. Therefore, no classification is required according to EU criteria.
- Executive summary:
In an acute oral toxicity study (OECD 423, Kr.1, GLP),Two groups of three female Crl:WI rats were treated with Alkenyl phosphonate at a dose level of 2000 mg/kg (Group 1 and Group 2). The test item was administered formulated in PEG 400 at a concentration of 200 mg/mL at a dose volume of 10 mL/kg bw. Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. As no mortality was observed, a confirmatory group (Group 2) was treated at the same dose level. No mortality was observed in the confirmatory group; therefore, no further testing was required according to OECD 423 and Commission Regulation (EC) NO 440/2008 of 30 May 2008, B.1.tris. Animals were observed for 14 days.
Alkenyl phosphonate did not cause mortality at a dose level of 2000 mg/kg bw. There were no systemic clinical signs noted in any animal throughout the study. There were no treatment related body weight changes. Body weight gains of Alkenyl phosphonate treated animals during the study showed no indication of a test item-related effect. There was no evidence of the macroscopic observations at necropsy at a dose level of 2000 mg/kg bw.
Under the conditions of this study, the acute oral LD50value of the test item Alkenyl phosphonate was found to be above 2000 mg/kg bw in female Crl:WI rats. Therefore, no classification is required according to EU criteria.
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