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EC number: 617-143-5 | CAS number: 80675-49-6
- 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
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- traditional method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-[(1E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(2-methoxyphenyl)-3-oxobutanamide
- EC Number:
- 617-143-5
- Cas Number:
- 80675-49-6
- Molecular formula:
- C18H18N4O6
- IUPAC Name:
- 2-[(1E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(2-methoxyphenyl)-3-oxobutanamide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Identifier: CAS 80675-49-6
- Lot/batch No.: L-7015-20
- Yellow powder
- Storage conditions: Ambient temperature, no protection from light necessary
Constituent 1
- Specific details on test material used for the study:
- - Identifier: CAS 80675-49-6
- Lot/batch No.: L-7015-20
- Analytical purity: 95%
- Yellow powder
- Storage conditions: Ambient temperature, no protection from light necessary
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V., The Netherlands
- Age at study initiation: 9 weeks
- Weight at study initiation: ♂: 258.6 - 287.8 g, ♀: 172.3 - 195.3 g
- Fasting period before study: none
- Housing: Groups of 5 of the same sex
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 - 70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2013-01-03 To: 2013-01-24
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: Nose-only apparatus
- Method of holding animals in test chamber: restraint tubes
- Source and rate of air: The flow of air at each tube was 1.0 L/min, which is sufficient to minimize re-breathing of the test aerosol as it is more than twice the respiratory minute volume of rats.
- System of generating particulates/aerosols: 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 four times during exposure using a Mercer 7 stage cascade Impactor (Model 02-130, In-Tox. Products Inc., Albuquerque, New Mexico, U.S.A.). The particle size distribution was measured by gravimetrically analyzing the test item deposited on each stage of the cascade impactor.
- Temperature, humidity, pressure in air chamber: The oxygen concentration of the test atmosphere was measured continuously during exposure using a calibrated device. The results were recorded manually and are reported at 30 minute intervals from the start of exposure. The oxygen concentration was maintained above 19 % during exposure. The temperature and relative humidity of the test atmosphere was measured continuously during exposure using a calibrated device. The results were recorded manually and are reported in 30 minute intervals from the start of exposure. The actual airflow rate through the exposure chamber was recorded in approximately 30 minute intervals from the start of the inhalation exposure.
TEST ATMOSPHERE
- Brief description of analytical method used: The test item usage was measured by weighing the generator cylinders containing the test item before and after exposure to determine the quantity of test item used. The weight used was then divided by the total air-flow volume to give the nominal concentration.
- Samples taken from breathing zone: yes
TEST ATMOSPHERE: See tables 1 and 2
- Rationale for the selection of the starting concentration: The target concentration was considered to be the highest technically achievable concentration with a respirable particle size as determined in the technical trials. A target concentration of 2 mg/L air for 4 hours is the accepted concentration for a limit test (OECD 403, “Acute Inhalation Toxicity”) if a respirable particle size cannot be achieved at higher concentrations. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 2.1 mg/L
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights were recorded prior to exposure on test day 1, and during the observation period on test days 2, 4, 8, and 15 before necropsy. Regarding clinical signs, 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.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 2.1 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- None
- Clinical signs:
- other: Clinical signs were limited to the day of treatment and consisted of slightly ruffled fur in all animals and slight tachypnea in 3 males and 2 females. From test day 2 onwards, all animals were free from clinical signs.
- Body weight:
- Slight body weight loss was noted between test days 1 and 2 in all males and 4 females. In 3 of those females, this finding persisted up to test day 4. Thereafter normal body weight development was recorded.
- Gross pathology:
- There were no macroscopical findings at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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