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EC number: 825-571-0 | CAS number: 60428-79-7
- 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

Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx 8 weeks
- Weight at study initiation: 141-184 g
- Fasting period before study: overnight fasting before dosing
- Housing: group housing of 3 animals
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:at least 5 days before dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 43-51
- Air changes (per hr): >= 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:
MAXIMUM DOSE VOLUME APPLIED:
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation was twice daily, weighing on Days 1, 8, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality
- Clinical signs:
- other: hunched posture, uncoordinated movements and/or piloerection were noted on days 1 and/or 2
- Gross pathology:
- no abnormalities
- Interpretation of results:
- other: substance has not to be classified according to Regulation 1272/2008
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- 2009
- GLP compliance:
- yes
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 268-300 (males), 203-228 g (females)
- Fasting period before study: no
- Housing: group housing up to 5 animals per cage and sex
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 49-54
- Air changes (per hr): >=
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: - Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- ca. 4.3 µm
- Geometric standard deviation (GSD):
- ca. 2.2
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: directed flow nose only inhalation chamber
- Exposure chamber volume:
- Method of holding animals in test chamber: restraining tubes
- Source and rate of air: approx. 1 l/min at each animal port
- Method of conditioning air:
- System of generating particulates/aerosols: Wright dust feeder
- Method of particle size determination: 8 stage Marple personal cascade impactor; collected dust fraction was determined gravimetrically
- Treatment of exhaust air: passed through a filter
- Temperature, humidity, pressure in air chamber: 20.1-21.6°C, 10-12%
TEST ATMOSPHERE
- Brief description of analytical method used:
- Samples taken from breathing zone: yes/no
VEHICLE
- Composition of vehicle (if applicable):
- Concentration of test material in vehicle (if applicable):
- Justification of choice of vehicle:
- Lot/batch no. (if required):
- Purity:
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 0.5 µm - approx. 10 µm
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 4.3 µm, GSD 2.2
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- ca. 4 h
- Concentrations:
- 5.0 +/- 0.1 mg/l
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation, weighing on days 1, 2, 4, 8, 15
- Necropsy of survivors performed: yes, macroscopic
- Other examinations performed: clinical signs, body weight - Key result
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- >= 5 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- no
- Clinical signs:
- other: after exposure, hunched posture and yellow staining (general) were seen for all animals between Days 1 and 4.
- Body weight:
- body weight loss was noted for all animals, this continued for three females up to Day 8, the animals regained weight during the second week.
- Gross pathology:
- no abnormalities observed
- Interpretation of results:
- other: no death at limit concentration
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
In the acute oral toxicity study no animal died after a single dose at a level of 2000 mg/kg body weight. The substance is a fine powder and an inhalation study for acute toxicicty has been performed indicating no toxicity at the limit dose of 5 mg/l. In the absence of acute systemic toxicity after a single oral dose at the limit dose and based on the physical-chemical properties of the substance limiting skin penetration no acute dermal toxicity is to be expected.
Accordingly, the substance does not need to be classified for acute toxicity according to Regulation 1272/2008.
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