Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 273-749-6 | CAS number: 69012-50-6 Product of blowing smelted nickel ore in a converter to lower the iron content.
- 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 30 - November 20, 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
- Reference Type:
- publication
- Title:
- Acute Oral Toxicity of Nickel Compounds
- Author:
- Henderson RG, Durando J, Oller A, Merkel DJ, Marone PA, and Bates HK.
- Year:
- 2 012
- Bibliographic source:
- Regul Toxicol and Pharmacol (doi.org/10.1016/j.yrtph.2012.02.002)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- no
Test material
- Reference substance name:
- Matte, nickel
- EC Number:
- 273-749-6
- EC Name:
- Matte, nickel
- Cas Number:
- 69012-50-6
- Molecular formula:
- Not applicable
- IUPAC Name:
- Nickel matte
- Details on test material:
- - Name of test material (as cited in study report): nickel matte, Code #N101
- Physical state: grey, black course granules
- Composition of test material, percentage of components: Nickel Subsulfides <60%, Nickel Iron Sulfides <40%, Copper >10%, Cobalt <1%, Arsenic <0.1%, and Magnesium Oxide 4%.
- Solubility: insoluble in water
- Expiration date of the lot/batch: Not Applicable
- Stability under test conditions: test substance was expected to be stable for the duration of testing
- Storage condition of test material: stored under nitrogen
- Test substance preparation: The test substance was ground in a coffee mill (Cuisinart, Model #DCG-20) every time prior to dosing. A tissue homogenizer (Tissue Tearor, Biospec, Model 985370) was used to facilitate the preparation of a homogeneous mixture.
- Other: Documentation of the methods, synthesis, fabrication, or derivation of the test substance retained by Sponsor.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley derived, albino
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Boyertown, PA. July 21, August 4, and 26, 2009.
- Age at study initiation: young adult (9-10 weeks).
- Weight at study initiation: 177-201 grams at experiment start
- Fasting period before study: overnight prior to dosing
- Housing: singly housed in suspended stainless steel caging with mesh floors; litter paper was placed beneath the cage and was changed at least three times per week
- Diet (e.g. ad libitum): Purina Rodent Chow #5012 ad libitum
- Water (e.g. ad libitum): filtered tap water ad libitum
- Acclimation period: 6-15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24 °C
- Humidity (%): Test 1: 51-78%
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: test substance administered as a 50% w/w mixture in a 0.5 % w/w mixture of CMC in distilled water - Doses:
- 790, 1000, 1260, 1580, 2000, 2510, 3200, 4000, and 5000 mg/kg bw
- No. of animals per sex per dose:
- 1 female at each dose of 790 -4000 mg/kg bw nickel matte
3 females at 5000 mg/kg bw nickel matte - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: cage-side observations during the first several hours post-dosing and at least once daily thereafter for 14 days
- Necropsy of survivors performed: yes; gross necropsies performed on all animals, tissues and organs of the thoracic and abdominal cavities were examined
- Other examinations performed: clinical signs, body weight, other: individual body weights were recorded prior to test substance administration (initial) and again on Days 7 and 14 (termination) following dosing. Cage-side observations included mortality, signs of gross toxicity, and behavioral changes including: gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observations of tremors, convulsions, salivation, diarrhea, and coma. - Statistics:
- The Acute Oral Toxicity(Guideline 425) Statistical Program (Weststat, version 1.0, May 2001) was used for all data analyses including: dose progression selections, stopping criteria determinations and/or LDso and confidence limit calculations.
Results and discussion
- Preliminary study:
- All animals survived (short-term and long-term outcomes indicated “survival”)
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- All animals survived
- Clinical signs:
- other: No signs of abnormal behavior were observed. All animals appeared active and healthy during the study.
- Gross pathology:
- No signs of gross toxicity or adverse pharmacologic effects were observed. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
- Other findings:
- Not Applicable
Any other information on results incl. tables
Dose Sequence | Animal No. | Dose Level (mg/kg) | Short-term Outcome | Long-term Outcome | BW-I | BW-7D | BW-14D |
1 | 3101 | 790 | Survived | Survived | 177 | 193 | 244 |
2 | 3102 | 1,000 | Survived | Survived | 177 | 193 | 231 |
3 | 3103 | 1,260 | Survived | Survived | 201 | 260 | 283 |
4 | 3104 | 1,580 | Survived | Survived | 195 | 216 | 244 |
5 | 3105 | 2,000 | Survived | Survived | 180 | 229 | 253 |
6 | 3106 | 2,510 | Survived | Survived | 179 | 201 | 220 |
7 | 3107 | 3,200 | Survived | Survived | 178 | 193 | 208 |
8 | 3108 | 4,000 | Survived | Survived | 181 | 212 | 233 |
9 | 3109 | 5,000 | Survived | Survived | 180 | 222 | 246 |
10 | 3110 | 5,000 | Survived | Survived | 192 | 223 | 250 |
11 | 3111 | 5,000 | Survived | Survived | 201 | 228 | 253 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this study, the acute oral LD50 of nickel matte is estimated to be greater than 5,000 milligrams per kilogram of body weight in female rats.
- Executive summary:
Eurofins Product Safety Laboratory (EPSL) reported the findings of the acute oral toxicity of nickel matte as determined by the acute toxicity up and down procedures in female rats (carried out according to OECD Test # 425 guidelines and using GLP standards). The Main Test included the following dose levels: 790, 1000, 1260, 1580, 2000, 2510, 3200, 4000, and 5000 mg/kg bw. Young adult female rats were administered a single gavage dose of nickel matte (Code #N101, described as grey, black course granules). The test substance was administered as a 50% w/w mixture in a 0.5% w/w mixture of CMC in distilled water. All animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily; body weight was monitored prior to dosing and again on Days 7 and 14, and all animals were necropsied following death or at study termination (Day 14). Following a single oral exposure to nickel matte , all animals survived, gained body weight, and appeared healthy and active during the study. No signs of gross toxicity, adverse pharmacologic effects, abnormal behavior, or gross abnormalities were observed. Under the conditions of these studies, the acute oral LD50 of nickel matte was estimated to be greater than 5,000 milligrams per kilogram of body weight in female rats. STUDY RATED BY AN INDEPENDENT REVIEWER
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.