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EC number: 942-548-1 | 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:
- 2021-09-22 to 2021-12-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
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 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:
- Salt reaction of cobalt(2+) and C2/C8/C20 carboxylates
- EC Number:
- 942-548-1
- Molecular formula:
- (CnH2n-102/Cn’H2n’-1O2) Co with n, n’ = 2 or 8 or 20
- IUPAC Name:
- Salt reaction of cobalt(2+) and C2/C8/C20 carboxylates
- Test material form:
- solid: pellets
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Saint-Germain-Nuelles, France
- Age at study initiation:8 weeks old at the beginning of the study
- Weight at study initiation: 183 - 208 g
- Fasting period before study: The rats were fasted approx. 1 day prior to dosing, with food being returned to the rats 4 hours after dosing.
- Housing: Animals were housed by group of three in solid-bottomed clear plycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust and was installed in conventional air conditioned animal husbandry
- Diet (ad libitum): Envigo - 2014
- Water: ad libitum
- 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:
- olive oil
- Details on oral exposure:
- Olive oil (vehicle) was chosen as it produced the most suitable formulation at the requested dose of 300 mg/Kg body weight.
For steps 1 & 2 (300 mg/Kg body weight), the preparations were stirred using a vortex for 3 minutes, by Ultraturrax for 3 minutes and manually to obtain black suspensions just before the administration.
For Step 3 (2000 mg/Kg body weight), the preparation was stirred using a vortex for 2 minutes and by Ultraturrax for 3 minutes at 10 000 rpm to obtain a black homogeneous suspension just before the administration.
For Step 4 (2000 mg/Kg body weight), the preparation was stirred using a vortex to obtain a black homogeneous suspension just beofre the administration.
Each preparation was administered by gavage, in a single dose, under a volume of 10 mL/ kg body waight (accounting to the calculated density) using a suitable syringe graduated fitted with an oesophageal metal canula. - Doses:
- 300 and 2000 mg/Kg body weight
- No. of animals per sex per dose:
- 300 mg/Kg body weight: 6 females
2000 mg/Kg body weight: 6 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Daily examination: Systematic examination were carried out to identify any behavioural or toxic effects on the major physiological functions 30 minutes, 1 hour +/- 6 minutes; 3 hours +/- 30 minutes, 4 hours +/- 30 minutes, 24 and 48 hours +/- 2 hours after administration of the test item and continued daily for 14 days. This examination focuses particularily on a list of symptoms recoreded as 'present' or 'absent'. These observations were compared to historical control data. Observations and a mortality report were then carried out 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. The body weight evolution of animals treated with the test item is compared with the body weight evolution of the control group.
- Examination at the end of the test: On D14, the animals were anesthetised with sodium pentoarbital. 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 levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: In accordance with the O.E.C.D. 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.
- Mortality:
- No mortality occured during the study at the dose of 300 mg/Kg body weight.
One mortality (1/6) was noted on day 6 at the dose of 2000 mg/Kg body weight. - Clinical signs:
- other: At the dose of 300 mg/Kg body weight, no clinical signs related to the administration of the test item were observed during the study. At the dose of 2000 mg/kg body weight, the mortality was preceeded by a decrease of spontaneous activity at 1-hour post-
- Gross pathology:
- At the dose of 300 mg/Kg body weight, the macroscopic examination of the animals at the end of the study did not reveal treatment related changes.
At the dose of 2000 mg/Kg body weight, the macroscopic examination of the dead animal revealed thin stomach membrances and advanced lysis of the digestive system, the urinary system and the reproductive system. The macroscopic examination at the end of the study revealed a thin proventricular (5/5) and fundic (2/5) wall, disintegrated when touched (1/5) with red spot (1/5) and transparent mass (1/5) on the fundic wall.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat.
In accordance with the O.E.C.D. test guideline n° 423, the LD50 cut-off of the test item may be considered as 2 500 mg/kg body weight by oral route in the rat..
In accordance with the Regulation EC n°1272/2008 on classification, labelling and packaging of substances and mixture, the test item does not have to be classified. 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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