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Diss Factsheets
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EC number: 482-670-8 | 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:
- from 1 September 2006 to 20 april 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: the study was performed according to internationally recognised guidelines and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- the temperature recorded was sometimes outside of the target ranges, but this minor deviation was not considered to have compromised the validity or integrity of the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- see higher
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- see higher
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: on the day of treatment, the animals were approximately 8 weeks old
- Weight at study initiation: on the day of treatment, the mean body weight was 199 ± 9 g
- Fasting period before study: approximately 18 hours before dosing (but free access to water)
- Housing: polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm). Each cage contained one to seven animals during the acclimation period and three rats during the treatment period.
- Diet: free access to SsniffR/M-H pelleted diet
- Water (e.g. ad libitum): drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2°C
- Humidity: 30 to 70%
- Air changes: approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod: 12hrs dark / 12hrs light
IN-LIFE DATES: from 13 September 2006 (first treatment) to 18 October 2006 (necropsy of the last animal)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 or 200 g/L
- Amount of vehicle: 10 mL
- Justification for choice of vehicle: no data
- Lot/batch no.: 015K0115 (Sigma, Saint-Quentin-Fallavier, France)
MAXIMUM DOSE VOLUME APPLIED: 10 mL
DOSAGE PREPARATION: the test item was ground to a fine powder using a mortar and pestle, then was prepared at the chosen concentrations in the vehicle
CLASS METHOD
- Rationale for the selection of the starting dose: based on information provided by the sponsor - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females at 300 mg/kg bw
2x3 females at 2000 mg/kg bw - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> Clinical signs and mortality: frequently during the hours following administration of the test item, at least once a day thereafter
> Body weight: the animals were weighed individually just before administration of the test item on day 1 and then on days 8 and 15.
- Necropsy of survivors performed: yes
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.
- Clinical signs:
- other: At 300 mg/kg, piloerection and dyspnea were noted in all the animals one hour after treatment. Piloerection was still observed 2 hours after treatment. No other clinical signs were noted thereafter, until the end of the observation period. At 2000 mg/kg,
- Gross pathology:
- Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 of neodymium tris(di-2-ethylhexylphosphate) is > 2000 mg/kg bw (with no mortality at this dose level).
- Executive summary:
In an acute oral toxicity study according to OECD 423, EC B.1 tris, US/EPA/OPPTS 870.1100 and GLP (CIT report 32229 TAR, 2007), scored as validity 1 according to Klimisch criteria, groups of fasted 8-week old Sprague-Dawley rats were given a single oral dose of neodymium tris(di-2-ethylhexylphosphate) in corn oil at the dose of 300 and 2000 mg/kg bw (3 and 2x3 females, respectively) and observed for 14 days. Clinical signs and mortality were checked frequently during the hours following administration of the test substance, and at least once a day thereafter. Body weight was measured just before administration of the test substance on day 1 and then on days 8 and 15.
No mortality occurred during the study.
At 300 mg/kg, piloerection and dyspnea were noted in all the animals one hour after treatment. Piloerection was still observed 2 hours after treatment. At 2000 mg/kg, piloerection was noted in 3/6 females 4 hours after treatment only.
No other clinical signs were noted thereafter, until the end of the observation period.
A slightly lower body weight gain was noted between day 8 and day 15 in 1/6 females treated at the dose-level of 2000 mg/kg, when compared to historical control animals. The overall body weight gain of the other animals treated at the dose-level of 300 or 2000 mg/kg was not affected by treatment with the test item.
At necropsy, no apparent abnormalities were observed in any animal.
Under the experimental conditions, the oral LD50 of the test item neodymium tris(di-2-ethylhexylphosphate) was higher than 2000 mg/kg in rats.
No classification for acute oral toxicity is warranted based on the absence of mortality up to 2000 mg/kg bw, according to the criteria of Annex VI Directive 67/548/EEC or UN/EU GHS.
This study is classified as acceptable, as it is performed according to OECD guideline and GLP.
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.
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