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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 234-454-8 | CAS number: 12004-35-2
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study, tested with CAS number 1313-99-1. In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Nickel monoxide
- EC Number:
- 215-215-7
- EC Name:
- Nickel monoxide
- Cas Number:
- 1313-99-1
- IUPAC Name:
- oxonickel
- Details on test material:
- - Name of test material (as cited in study report): nickel oxide
- Substance type: test substance
- Physical state: dark grey, odorless granules
- Composition of test material, percentage of components: nickel monoxide 98%; colbaltous oxide 1.5%
- Stability under test conditions: expected to be stable for the duration of testing
- Storage condition of test material: kept in a tightly closed container under nitrogen
- Other: Insoluble in water
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Robinson Services, Inc. Clemmons, NC
- Age at study initiation: Young adult
- 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): Not specified; Pelleted Purina Rabbit Chow #5326
- Water (e.g. ad libitum): as libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 66-83% - The humidity was above the targeted upper limit of 70% during the study due to exceptionally high, seasonal humidity. Portable dehumidifiers were used to lower the humidity levels during this time.
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye of each rabbit remained untreated with the test substance and served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): One-tenth of a millimeter (0.1 g) - Duration of treatment / exposure:
- Treatment instilled into the conjunctival sac of the right eye of each rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimize loss of the test substance.
- Observation period (in vivo):
- 4 days (scoring 1, 24, 48, and 72 hours, 4 days) post-instillation
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Scale for scoring ocular lesions (scores 0-4, according to Draize et al., 1944)
TOOL USED TO ASSESS SCORE: high-intensity, white light (Maglite), fluorescein dye procedure (one drop of 2% ophthalmic fluorescein sodium was instilled into both eyes of each rabbit. The eyes were rinsed with physiological saline [0.9% NaCl] approximately 30 seconds after instillation of the fluorescein.)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 9.3
- Max. score:
- 110
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 9.3
- Max. score:
- 110
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 3.3
- Max. score:
- 110
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 1.3
- Max. score:
- 110
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.7
- Max. score:
- 110
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 4 d
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- other: no effect
- Irritant / corrosive response data:
- Incidence of Positive Effects (1 h, 24 h, 48 h, 72 h, 4 d):
Corneal Opacity: 0/3, 0/3, 0/3, 0/3, 0/3
Iritis: 0/3, 0/3, 0/3, 0/3, 0/3
Conjunctivitis: 3/3, 0/3, 0/3, 0/3, 0/3 - Other effects:
- All animals appeared active and healthy during the study. Apart from the eye irritation noted below, there were no other signs of gross toxicity, adverse pharmacologic effects, or abnormal behavior.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
- Eurofins Product Safety Laboratory (EPSL) conducted a primary eye irritation study in rabbits according to OECD Test #405- Acute Eye Irritation/Corrosion and using GLP standards. The study was completed on 2008-10-07 and the final report issued on 2008-12-04. Nickel oxide sinter (Nickel oxide green) (one-tenth of a milliliter, or 0.10 grams) was instilled into the right eye of three healthy female rabbits to determine the potential to produce irritation. The left eye served as a control in each animal. Ocular irritation was then evaluated according to the Draize scoring system at multiple time points (1, 24, 48, and 72 hours, and 4 days) following instillation. Individual animals were assessed for effects in the cornea, iris, and conjunctivae, as well as other lesions, gross toxicity, and behavioral changes. In the treated eyes, no corneal opacity or iritis was observed in any of the animals, though all three treated eyes exhibited positive conjunctivitis one hour after instillation. All observed effects were reversible; incidence and severity of irritation decreased with time and all animals were free of ocular irritation by Day 4. Aside from eye irritation, no other signs of gross toxicity, adverse pharmacologic effects, or abnormal behavior were observed in the animals. 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.