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Diss Factsheets
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EC number: 948-264-4 | 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:
- 2018-01-17 to 2017-04-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- dated 17 December 2001
- Deviations:
- yes
- Remarks:
- Environmental parameters : relative humidity lower than 30% (minimum = 25%) - this deviation is considered without impact on the conclusion of the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- dated 30 May 2008
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- dated 27 April 2017
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Complexation products of bismuth(3+) neodecanoate with propane-1,2-diol, propoxylated and 2,2',2'',2'''-ethylenedinitrilotetraethanol
- EC Number:
- 948-264-4
- IUPAC Name:
- Complexation products of bismuth(3+) neodecanoate with propane-1,2-diol, propoxylated and 2,2',2'',2'''-ethylenedinitrilotetraethanol
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER LABS, Le Genest St Isle, France
- Age at study initiation: 8 weeks old at the beginning of the study
- Weight at study initiation: 188 - 208 g
- Fasting period before study: Food was removed on day -1 and then redistributed 4 hours after adminsitration of the test item.
- Housing: Animals were housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust and was installed in conventional air conditioned animal husbandry
- Diet (ad libitum): Envigo - 2016
- Water: ad libitum, tap-water from public distribution system
- Acclimatization period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 25 °C
- Relative humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12
- Rate of air exchange : at least 10 changes per hour
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- In the first and second step of the study,the test item was administered by gavage under a volume of 1.75 mL/Kg body weight (corresponding to 2 g/Kg, according to the calculated density) using a suitable graduated syringe fitted with an oesophageal metal canula.
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 + 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Daily examination: Systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions during 14 days following the administration of the test item. This examination focuses particularly on a list of symptonms, recorded as 'present' or 'absent'. These observations were compared to historical control data. Clinical observations and mortality were recorded every day for 14 days.
- Periodical examinations: The animals were weighed on D0 (just before administering the test item) then on D2, D7 and D14. Weight changes were calculated and recorded.
- Examination at the end of the test: On D14, the animals were anesthetised with sodium pentobarbital (Dolethal). Macroscopic observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of acute toxicity were examined. No organ was removed and preserved in view to microscopic examinations.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- < 5 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: calculation - LD50 cut-off of the test item
- Mortality:
- Two mortalities (2/6) were noted in animals treated at 2000 mg/Kg body weight on day 4 (step 1) or day 3 (step 2) post-dose.
- Clinical signs:
- other: The mortalities were preceded by an absence of spontaneous activity (2/2), muscle tones (1/2), Preyer's reflex (1/2), righting reflex (2/2) associated with piloerection (2/2). In the surviving animals (4/6), a decrease of spontaneous activity (4/4) and Pr
- Gross pathology:
- The macrosscopic examination of the animals died during the study revealed a thinning of corpus and cellular lyse (2/2).
The macroscopic examinations of the animals at the end of the study (surviving animals) did not reveal treatment related changes.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the test item is higher than 2000 mg/kg body weight and lower than 5000 mg/Kg body weight by oral route in the rat.
In accordance with the OECD Test Guideline n° 423, the LD50 cut-off of the test item may be considered as 2500 mg/Kg body weight by oral route in the rat.
The test item does not have to be classified in accordance with the Regulation EC n° 1272/2008 on classification, labelling and packaging of substances and mixtures. No signal word or hazard statement is required.
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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