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EC number: 224-699-9 | CAS number: 4454-16-4
- 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:
- 07 July 2022 - 26 July 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Nickel bis(2-ethylhexanoate)
- EC Number:
- 224-699-9
- EC Name:
- Nickel bis(2-ethylhexanoate)
- Cas Number:
- 4454-16-4
- Molecular formula:
- C8H16O2.1/2Ni
- IUPAC Name:
- nickel(2+) bis(2-ethylhexanoate)
- Test material form:
- solid
- Remarks:
- dark green paste
- Details on test material:
- Supplier: Shepherd Mirecourt S.A.S.
CAS Number: 4454-16-4
Batch/Lot number: L8147
Appearance: dark green paste
Purity: ≥94%
Ni content: 15.82 %
Expiry date: 17 November 2022
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Han:WIST rats
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Toxi-Coop Zrt., H-1122 Budapest, Magyar Jakobinusok tere 4B
- Hygienic level at supplier: SPF
- Hygienic level during the study: Standard housing conditions
- Number of animals: 9 animals, 3 animals/group
- Sex: Female, nulliparous and non-pregnant animals
- Age of animals at dosing: Young adult rats, approx. 8 weeks old
- Body weight range at dosing: 170 - 184 g. The maximum difference of individual animal weights from the mean of the treatment group did not exceed 20%.
- Acclimatisation period: At least 15 days
- Animal health: Only healthy animals were used for the test. The health status was certified by the Veterinarian.
- Housing: Group caging (3 animals/cage)
- Cage type: T3H polycarbonate
- Bedding and nesting: “SAFE 3/4-S-FASERN” certified wooden chips and “Sizzle pet” nest material were available to animals during the study.
- Enrichment: Animals were housed by group to allow social interaction and with deep wood sawdust bedding to allow digging and other normal rodent activities.
- Animals received standard laboratory rat diet, ad libitum, and tap water from the municipal supply, as for human consumption from drinking bottles designed for rodents, ad libitum.
- The night before treatment, the animals were fasted. Food, but not water, was withheld overnight. Animals were weighed before dosing. Food was replaced 3 hours after the treatment.
ENVIRONMENTAL CONDITIONS
- Lighting period: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
- Temperature: 19 – 24 °C (target: 22 ± 3 °C)
- Relative humidity: 34 – 70 % (target: 30 – 70 %)
- Ventilation: 15-20 air exchanges/hour
IN-LIFE DATES: From 07 July 2022 to 26 July 2022
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Remarks:
- Batch number: MKCM9808 Manufacturer: Sigma-Aldrich Expiry date: 30 April 2026 Storage: Room temperature
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 or 30 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: The test item did not dissolve in distilled water, in 1% methyl cellulose solution and in PEG 400 (even if heated up to approximately 60º C), and dissolved partially in corn oil.
Because the best results were achieved in corn oil, a harsher mechanical treatment was chosen: the sonication (with a 1.3mm disruption horn) of the test item with corn oil resulted in a gavage-applicable clear solution of green color.
DOSAGE PREPARATION: The test item was freshly formulated in the vehicle at the appropriate concentration (200 or 30 mg/mL), in the Pharmacy of NEXTREAT Laboratories on the day of administration. The formulations were stirred with magnetic stirrer up to finishing the treatment.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As starting dose level for acute toxicity study, a dose of 2000 mg/kg body weight (bw) was selected based on the information published by ECHA.
- Initially three animals were treated at the starting dose of 2000 mg/kg bw (Group 1). All three animals died on Day 0, thus the second group (Group 2) was treated at the lower dose level (300 mg/kg bw). As no mortality observed after approximately 24 hours, three further animals were treated at the same dose level (Group 3). As no mortality was observed in this confirmatory dose group, no further animals were treated according to the study design of OECD 423. - Doses:
- 2000 mg/kg bw or 300 mg/kg bw
- No. of animals per sex per dose:
- 3 female animals per group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Clinical observations: Following the end of the dosage, the animals were observed individually once during the first 30 minutes, at 1, 2, 3, 4 and 6 hours after the treatment and once daily for 14 consecutive days thereafter. Individual observations were performed on the skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. The time of death was recorded as precisely as possible.
- Body weight: The body weight of the animals was recorded on Days 0 (prior to dosing), 7 and 14 (prior to necropsy), with a precision of 1 g. Terminal body weight of animals found dead was also recorded.
- Necropsy: Animals were subjected to a necropsy and a macroscopic examination. After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs were observed. All gross macroscopic changes were recorded for each animal. - Statistics:
- The method used was not intended to allow the calculation of a precise LD50 value.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - <= 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- At the dose level of 2000 mg/kg bw, 3/3 animals died on Day 0.
No mortality was observed at the dose level of 300 mg/kg bw. - Clinical signs:
- other: other:
- Body weight:
- lower than 10% body weight loss
- Gross pathology:
- In the 2000 mg/kg bw groups, three animals were found dead on Day 0. In these animals diffuse red discoloration of the glandular mucosa of the stomach was observed. Green mucoid material in the stomach and non-collapsed lungs were also noted in all animals.
In the 300 mg/kg bw group, no macroscopic changes were observed.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- The test substance is classified Category 4 according to Regulation (EC) No 1272/2008 (CLP)
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item Nickel-2-ethylhexanoate was found to be between 300 and 2000 mg/kg bw in female Han:WIST rats.
The LD50 cut-off value is 500 mg/kg bw.
The study result triggers the following classification/labelling:
- Regulation (EC) No 1272/2008 (CLP): Category 4
- GHS (rev. 9) 2021: Category 4
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