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EC number: 480-340-8 | 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:
- June 10th to 25th, 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
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 December 17th, 2001
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 480-340-8
- EC Name:
- -
- Cas Number:
- 156157-97-0
- Molecular formula:
- C12H30Cl2N2Na2O14
- IUPAC Name:
- Di(µ-2,2´,2´´-nitrilotris(ethanol)-diperchlorato)dinatrium
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- SPF Caw
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER (53490 Le Geneste St Isle - France).
- Age at study initiation: 8 weeks old.
- Weight at study initiation: 179 - 204 g.
- Fasting period before study: food was removed at day one and then redistributed 4 hours after the item administration.
- Housing: solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week.
- Diet: ad libitum.
- Water: tap water from public distribution system, ad libitum.
- Acclimation period: at least five days.
ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 23 °C.
- Humidity: 41 - 70 %.
- Air changes: ten changes per hour.
- Photoperiod: 12 hrs dark/12 hrs light.
- Other: conventional air conditioned animal husbandry.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VOLUME APPLIED: 10 ml/kg b.w.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- six female rats (three animals per step).
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Type and frequency of observations: systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions. The observations were performed by comparison with the control animals standing in the same environment. Mortality report and observations were carried every day for 14 days; the first day the animals were observed at 30 min, 1 hr, 3 hrs, 4 hrs and then daily thereafter. Observations include: spontaneous activity, preyer's reflex (noise), respiratory rate, convulsions, tremors, body temperature, muscle tone, palpebral opening, pupil appearance, salivation, lachrymation, righting reflex, back hair appearance.
- Frequency of weighing: on day 0 (just before the administration of the test item) then on day 2, day 7 and day 14.
- Necropsy: on day 14 animals were anaesthetised with sodium pentobarbital and administration continued to fatal levels. Macroscopic obcervations were reported individually. Only those organs likely to be modified in cases of acute toxicity were performed. Those presenting macroscopic anomalies were removed and preserved for microscopic examinations.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality occured.
- Clinical signs:
- decrease of spontaneous activity in the treated animals (6/6) from 3 hrs after administration. The animals recovered a normal activity the 2nd day of the test.
- Body weight:
- body weight evolution remained normal throught the study.
- Gross pathology:
- the macroscopical examination did not reveal any treatment-related changes.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC) No.1272/2008.
- Conclusions:
- LD50 > 2000 mg/kg b.w.
- Executive summary:
The acute oral toxicity of the test material in the female Sprague-Dawley strain rat was assessed in this limit acute toxic class test coducted according to the OECD Guideline 423 and EU Method B.1 tris. For this reason, three female rats were used in each step and they were given one single oral dose of the substance at dose level of 2000 mg/kg b.w. The animals were observed for fourteen days for signs for clinical signs, toxicity and for deaths. Body weights were recorded prior to dosing, weekly thereafter and at the end of the test. At the end of the test the survived animals were killed and were subjected to gross pathological examination.
No mortality occured and no macroscopic changes were observed. The animals showed normal bodyweight gain. The only observation was the decrease of spontaneous activity in the treated animals (6/6) from 3 hrs after administration. However, the animals recovered a normal activity the 2nd day of the test.
LD50 > 2000 mg/kg b.w.
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