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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 269-093-5 | CAS number: 68187-40-6 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77364.
- 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:
- 2019-10-30 to 2019-11-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001-12-17
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2008-05-31
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2017-05-08
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Olivine, cobalt silicate blue
- EC Number:
- 269-093-5
- EC Name:
- Olivine, cobalt silicate blue
- Cas Number:
- 68187-40-6
- Molecular formula:
- Co2SiO4
- IUPAC Name:
- silicon(4+) bis(λ²-cobalt(2+)) tetraoxidandiide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Test item identification: Olivine, cobalt silicate blue (Pigment Blue 73)
- Substance type: inorganic pigment
- Storage condition of test material: Keep dry and container tightly closed. Keep container in an adequately ventilated storage
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD/Crl: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 54 days
- Weight at study initiation: 186 - 220 g
- Fasting period before study: Feeding was discontinued approx. 16 hours before administration; only tap water was then available ad libitum. After administration, food was withheld for approx. 3 hours.
- Housing: during the 14-day observation period the animals were kept in groups of 3 animals in MAKROLON cages (type III plus). Granulated textured wood (Granulat A2, J. Brandenburg, 49424 Goldenstedt, Germany) was used as bedding material for the cages. The cages were changed and cleaned twice a week.
- Diet: ad libitum, commercial diet, ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water: ad libitum, drinking water in bottles
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3°C (maximum range)
- Humidity: 55 ± 10% (maximum range)
- Air changes: 15 to 20 times per hr
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 2019-10-30 To: 2019-11-18
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous hydroxypropyl methylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg/kg bw
- Amount of vehicle: 1.9 - 2.2 mL
- Justification for choice of vehicle: 0.8% aqueous hydroxypropylmethylcellulose was chosen as inert vehicle as it is known not to produce any toxic effects and revealed a homogenous and stable suspension of the test item for application in the organism of the animals.
- Batch no.: DTR459964
- Source: Colorcon GmbH, 65510 Idstein, Germany
MAXIMUM DOSE VOLUME APPLIED: 10 mg/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Following administration, observations were made and recorded systematically with individual records being maintained for each animal. Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration.
- Necropsy of survivors performed: yes, at the end of the experiments, all animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded.
- Other examinations performed: During the follow-up period of two weeks, changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system and somatomotor activity as well as behaviour pattern were observed at least once a day until all symptoms subsided, thereafter each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. Observations on prematurely deceased animals were made at least once daily to minimize loss of animals during the study. The time of death would have been recorded as precisely as possible. Individual body weights were recorded shortly before administration of the test item and thereafter in weekly intervals up to the end of the study. Changes in weight were calculated and recorded when survival exceeded one day. No histopathology was carried out as no macroscopical findings were noted at autopsy. - Statistics:
- No statistical analysis could be performed (the method used is not intended to allow a calculation of a precise LD50 value).
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality could be observed.
- Clinical signs:
- other: No clinical signs were noted.
- Gross pathology:
- No pathological changes were observed at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A single oral administration of Cobalt silicate olivine (Pigment blue 73)/kg b.w. did not reveal any signs of toxicity in any of the 6 animals. The LD50 value for female rats is >2000 mg Cobalt silicate olivine (Pigment blue 73)/kg bw.
According to the EC Regulation 1272/2008 and subsequent regulations, the test item does not require classification for acute oral toxicity.
According to the Globally Harmonized Classification System (GHS) the test item requires no labelling for acute oral toxicity (as LD50 > 2000 mg/kg b.w.). - Executive summary:
Cobalt silicate olivine (Pigment blue 73) was examined for acute toxicity after a single oral administration to rats (acute toxic class method). The test substance was suspended in 0.8 aqueous hydroxypropyl methylcellulose and administered via gavage to 6 female rats. Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. All animals were observed for a period of 14 days. Individual body weights were recorded shortly before administration of the test item and thereafter in weekly intervals up to the end of the study. At the end of the study, all animals were necropsied. No histopathology was carried out.
Under the present test conditions, a single oral administration of 2000 mg Cobalt silicate olivine (Pigment blue 73)/kg b.w. did not reveal any signs of toxicity in any of the 6 animals. All animals gained the expected body weight. No pathological changes were observed at necropsy.
The LD50value was ranked exceeding 2000 mg/kg bw.
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.