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EC number: 617-219-8 | CAS number: 81334-34-1
- 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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-01-17 to 2013-04-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Harlan Laboratories Ltd, Toxicology and Environmental Safety & Metabolism, Zelgliweg 1, 4452 Itingen, Switzerland
- Test type:
- traditional method
- Limit test:
- yes
Test material
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: COD-001701
- Expiration date of the lot/batch: 2014-11-01
- Purity test date: 2012-10-24
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature (or cooler)
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- RccHanTM:WIST(SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V. Kreuzelweg 53 5961 NM Horst, Netherlands
- Age at study initiation: 8 weeks
- Weight at study initiation: Males: 263.2 to 280.4 g, Females: 177.8 to 193.8 g
- Fasting period before study: no
- Housing: Animals were housed in groups of 5 of the same sex in Makrolon® type-IV cages with wire mesh tops including paper enrichment and standard softwood bedding
- Diet: pelleted standard Harlan Teklad 2914C rat maintenance diet (ProvimiKliba AG, 4303 Kaiseraugst, Switzerland) ad libitum (except for period of restrainment in test tube)
- Water: community tap water from Füllinsdorf ad libitum (except for period of restrainment in test tube)
- Acclimation period: 6 days under optimal hygienic laboratory conditions. The animals were accustomed to the restraining tubes for 30 minutes on the day of exposure.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 to 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2013-01-22 To: 2013-02-11
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Remarks:
- flow-past exposure
- Vehicle:
- not specified
- Mass median aerodynamic diameter (MMAD):
- >= 2.61 - <= 3.01 µm
- Geometric standard deviation (GSD):
- >= 2.36 - <= 2.82
- Remark on MMAD/GSD:
- Duration of sampling: 25 to 27 seconds per sample
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: flow-past, nose-only exposure system
- Method of holding animals in test chamber: restraining tubes
- Source and rate of air: The flow of air at each tube was 1.0 L/min
- Method of conditioning air:
- System of generating particulates/aerosols: A dust aerosol was generated from the test item using a CR3020 rotating brush aerosol generator connected to a micronizing jet mill.
- Method of particle size determination: The particle size distribution of the test aerosol was determined three times during exposure using a Mercer 7 stage cascade Impactor (Model 02-130, In-Tox. Products Inc., Albuquerque, New Mexico, U.S.A.).
- Temperature, humidity, pressure in air chamber: 22.8°C (mean), 5.5% RH (mean)
TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetric analysis of Aerosol concentrations: The samples were collected on a Millipore®durapore filter, Type HVLP loaded in a 47 mm inline stainless steel filter sampling device. The filters were weighed before and immediately after sampling using a calibrated balance. The test aerosol concentration was calculated from the amount of test item present on the filter and the sample volume.
- Gravimetric aerosol concentration: 2.1 mg/L air (mean)
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: the particle size distributions obtained were considered to be respirable to rats and appropriate for acute inhalation toxicity testing.
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 2.61 to 3.01 / 2.36 to 2.85 - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- ca. 4 h
- Concentrations:
- 2.4 mg/L air (mean chemical aerosol concentration)
- 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: Each animal was examined three times during exposure, immediately and 1 h after exposure on test day 1 and once daily during the observation period.
- Frequency of weighing: The body weight of each animal was recorded on test days 1 (before exposure), 2, 4, 8 and 15 (before necropsy).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- No statistical analysis was performed as only one group was allocated to the study.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- discriminating conc.
- Effect level:
- > 2.4 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality occured
- Clinical signs:
- other: Clinical signs were limited to the day of treatment and consisted of slight salivation during exposure and slightly ruffled fur immediately and one hour after exposure. Furthermore, tachypnea was noted in one male and three females during and shortly afte
- Body weight:
- Only marginal weight loss or stagnation was noted. This effect was considered to be mainly due to the restraining of the animals in the tubes.
- Gross pathology:
- There were no treatment-related macroscopic findings at necropsy.
- Other findings:
- - Histopathology: All collected organ and tissue samples were retained but neither processed nor examined.
- Potential target organs: not included
- Other observations: not included
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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.
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