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Diss Factsheets
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EC number: 258-221-5 | CAS number: 52846-56-7
- 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
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Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 5 May 1981 to 19 MAY 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Relevant methodological deficiencies, poor documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Company guideline
- Deviations:
- no
- Principles of method if other than guideline:
- test for acute toxicity after inhalation exposure (dust exposure in open, dynamic system)
- GLP compliance:
- no
- Remarks:
- study was performed previous to GLP implementation
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-[(4-chloro-2-nitrophenyl)azo]-N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide
- EC Number:
- 235-462-4
- EC Name:
- 2-[(4-chloro-2-nitrophenyl)azo]-N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide
- Cas Number:
- 12236-62-3
- Molecular formula:
- C17H13ClN6O5
- IUPAC Name:
- 2-[(4-chloro-2-nitrophenyl)diazenyl]-3-oxo-N-(2-oxo-2,3-dihydro-1H-benzimidazol-5-yl)butanamide
- Test material form:
- solid: bulk
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: own breed
- Weight at study initiation: males: mean 199 g (range: 196 to 201 g); females: mean 205 g (range: 195 to 216 g)
- Housing: plastic cages
- Diet: Standard husbandry diet Altromin 1324 (Altromin GmbH, Lage/Lippe, Germany), ad libitum
- Water: tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 °C (in exposure cylinder)
- other measurmenst during dust exposure: 21% oxygen, 5000 ppm carbon dioxid, no carbon monoxide
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: cylindrical plastic cage
- Exposure chamber volume: 60 L
- Method of holding animals in test chamber: each animal was in a plastic tube
- Source and rate of air: laminar air stream of 900 L/hour at 1 bar from above
- System of generating particulates/aerosols: dustgenerator "Wright Dust Feed Mechanism" of L. Adams Ltd., London, UK
- Treatment of exhaust air: exhaust device at the basement of the exposure chamber in line with a diverse system of filters
TEST ATMOSPHERE ANALYSIS
- Brief description of analytical method used: gravimetric measurement: The test atmosphere was sucked through filters ("Experimentiertrommelgasfilter", Elster AG, Mainz-Kastel, Germany; as well as a fibre glass and a membrane filter (diameter of pores 0.65 µm) Sartorius Membranfilter GmbH, Göttingen, Germany) by means of vacuum (at 1200 L/h). The exhaust quantity was 10 L/min. The filters were positioned in an exsiccator 24 h before use. The filters were weighed before and after each measurement by means of electrical scales (Sartorius-Werke GmbH, Göttingen, Germany).
- Waste treatment: After the filters 2 washing bottles, filled with water and polyglycol 400, were placed. Dust leaving the test chanmber due to high pressure was sucked into a gas cleaning station.
TEST ATMOSPHERE
- Particle size distribution: > 0.65 µm - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetric measurement
- Duration of exposure:
- 4 h
- Concentrations:
- mean: 1274 mg/cubic metre air
range: 521 to 2511 mg/cubic metre air
Concentration applied was the maximum technically feasible concentration. - No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily except on weekends
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 1 274 mg/m³ air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: maximum feasible concentration tested; no animals died within the 14 day observation period
Any other information on results incl. tables
- no deaths occurred
- during dust exposure rats showed unsteady breathing
- behaviour of the rats was normal during the 14 days observation period
- body weight development was normal during the 14 days observation period
- no gross organ changes were seen at necropsy
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Exposure of male and female Wistar rats to 1274 mg/m³ test item (i.e. maximum technically feasible concentration) for 4 hours did not result in the death of the animals during a 14 day observation period, resulting in a LC50 value of > 1274 mg/m³.
- Executive summary:
Acute inhalation toxicity of the test item has been investigated in male and female Wistar rats. Mean dust exposure concentration was 1274 mg test substance per cubic metre (i.e. maximum technically feasible concentration; exposure ranged from 521 to 2511 mg/ cubic metre). The rats were exposed for 4 hours, nose only. All animals survived the 14 day observation period. No macroscopic visible changes were observed at necropsy at the end of the observation period, resulting in a LC50 value of > 1274 mg/m³ for the inhalation of dust.
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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