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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- Version February 24, 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- Version August 1998
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nosan No. 8147 as this in line with the OECD Guideline 402
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute 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: Crl:WI (Han) SPF rats from Charles River Deutschland GmbH, 97633 Sulzfeld, Germany.
- Age at study initiation: young adult animals (♂: ~8 weeks, ♀: ~12 weeks)
- Weight at study initiation: ♂: 259.6 ± 6.11 g, ♀: 215.8 ± 1.30 g
- Housing: single caging in Makrolon cages type III
- Diet: ad libitum, H 15005-29; Ssniff, Spezialitaeten GmbH (Experimental Animal Diets Inc., 59494 Soest, Germany)
- Water: ad libitum, tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ø 22 - 26 (continuous control and recording)
- Humidity (%): ø 20 - 80 (continuous control and recording)
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- olive oil
- Remarks:
- suspension
- Details on dermal exposure:
- TEST SITE
- Area of exposure: clipped epidermis (dorsal and dorsolateral parts of the trunk)
- % coverage: ~ 40 cm² (corresponds to at least 10 % of the body surface)
- Type of wrap if used: a semi occlusive dressing. The bandage consists of four layers absorbent gauze (Ph. Eur. Lohmann GmbH & Co. KG, Germany) and Fixomull stretch (adhesive fleece, Beiersdorf AG, Germany).
REMOVAL OF TEST SUBSTANCE
- Washing: rinsing of the application site with warm water.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount applied: 6.67 g/kg (The dosing was provided in g by using a scale, because the test substance preparation in a higher concentration is a paste and the preparation is not applicable in mL)
- Concentration: 30 g/100 mL (suspension)
- For solids, paste formed: yes
VEHICLE
- Amount applied: see above; the test-item preparation was prepared shortly before application. The homogeneity of the test item during application was achieved by stirring with an Ultraturrax and a magnetic stirrer.
- Reason for the vehicle: Good homogeneity in olive oil Ph.Eur./DAB - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- 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: individual body weights were determined shortly before administration (day 0), weekly thereafter and on the last day of observation. Recording of clinical signs was performed several times on the day of administration and at least once daily thereafter each workday for the individual animals. A check for any dead or moribund animal was made at least once each workday; these records are archived by Bioassay.
- Necropsy of survivors performed: yes; necropsy with gross-pathology examination on the last day of the observation period after sacrifice with CO2 in a chamber with increasing concentrations over time
- Other examinations performed: Scoring of skin findings with individual readings 30 – 60 minutes after removal of the semi-occlusive dressing (day 1), several times until the last day of observation and on the last day of observation.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: - Systemic effects: no systemic clinical observations were performed during clinical examination. - Local effects: due to a yellowish discoloration of the application area caused by the test article, erythema could not be evaluated in all animals on study
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.
Any other information on results incl. tables
Table 1: Body weight changes
Sex |
Mean body weight (g) ± SD at indicated time period |
||
|
Day 0 |
Day 7 |
Day 14 |
Male animals |
259.8 ± 6.11 |
279.4 ± 7.64 |
317.4 ±1 4.05 |
Female animals |
215.8 ± 1.30 |
217.6 ± 2.97 |
225.2 ± 5.45 |
SD: Standard deviation |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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