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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: oral
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- Version 2001-12-17
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- Version 1998-07
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nosan No. 8147
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
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:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Crl:(WI)BR rats from Charles River Deutschland GmbH, 97633 Sulzfeld, Germany.
- Age at study initiation: ~ 8 weeks at administration
- Weight at study initiation: 185 ± 2 g (3 animals of the first treatment step) 186 ± 6 g (3 animals of the second treatment step).
- Housing: single caging in Makrolon cages type III (39 cm x 23 cm bottom area, 18 cm height). Wire mesh lids. Sanitation of cages once a week.
- Diet: ad libitum, Ssniff R/M-H maintenance diet for rats and mice (item V1534-3 ) (Ssniff Spezialdiäten GmbH, 59494 Soest, Germany).
- Water: ad libitum, tap water from an automatic watering system.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ø 22.9 (continuous control and recording)
- Humidity (%): ø 48.3 (continuous control and recording)
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE:
- Concentration in vehicle: 100 mg/mL
- Amount of vehicle: 20 mL/kg
- Justification for choice of vehicle: The test substance was suspendable with water. According to the guidelines, water shall be used preferably.
MAXIMUM DOSE VOLUME APPLIED:
- 20 mL/kg
DOSAGE PREPARATION:
- The suspensions were prepared freshly before administration and were administered within 10 minutes after the preparation.
CLASS METHOD:
- Rationale for the selection of the starting dose: as requested by the sponsor, a starting dose of 2000 mg/kg bw test substance was chosen. The further proceeding was in accordance with the followed guideline/directive. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - According to Annex 2d of the OECD guideline and Annex 1d of the EC-Directive two groups of 3 females each were used for the stepwise dosing.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations (including but were not limited to changes in skin, fur, eyes, the occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions) were performed 0.5, 1, 2, 3, 4, and 6 hours after administration (p.a.) of the test substance and then at least once a day for a total of 2 weeks; body weights (before administration, 7 days p.a. and 14 days p.a.); and body weight gain (calculated between 0 and 7 days p.a. and between 7 and 14 days p.a.)
- Necropsy of survivors performed: yes; the animals were sacrificed by inhalation of 80 % CO2 + 20 % air 14 days p.a. and subjected to a necropsy including a gross pathological examination.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality was observed.
- Mortality:
- All animals survived until the scheduled termination of the study.
- Clinical signs:
- other: No abnormalities were observed during study period.
- Gross pathology:
- No animal showed any abnormal finding at the necropsy 14 days p.a.
Any other information on results incl. tables
Table 1: Body weights and body weight gain
Treatment step – Dose level (mg/kg bw) |
Mean body weight (g) ± SD |
Deaths |
Mean body weight gain (g) ± SD |
|||
Day 0 |
Day 7 |
Day 14 |
0-7 days |
7-14 days |
||
Step 1 – 2000 |
185 ± 2 |
215 ± 4 |
225 ± 4 |
- |
29.7 ± 4.0 |
10 ± 6.2 |
Step 2 – 2000 |
186 ± 6 |
229 ±10 |
257 ± 31 |
- |
43.3 ± 5.1 |
28.0 ±2 0.9 |
SD: standard deviation |
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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