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EC number: 430-500-8 | CAS number: 204277-61-2
- 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
- Study period:
- 22 December 1998 to 14 January 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP methodology followed and OCED guideline 423 used to performed the experiment.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 430-500-8
- EC Name:
- -
- Cas Number:
- 204277-61-2
- Molecular formula:
- Hill formula: C23 H23 Cl N6 O8 CAS formula: C23 H23 Cl N6 O8
- IUPAC Name:
- methyl 2-({4-[2-(2-chloro-6-cyano-4-nitrophenyl)diazen-1-yl]-5-acetamido-2-methoxyphenyl}(2-methoxy-2-oxoethyl)amino)propanoate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- None
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Rat HanIbm: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: RCC Ltd, Biotechnology & Animal Breeding Division, CH-4414 Füllinsdorf / Switzerland
- Age when treated: 8 weeks (male) and 10 weeks ( female)
- Body weight rage when treated: 200.7-214.8 g (male) and 176.6-184.2 (female)
- Identification: By unique cage number and corresponding color-coded spots on the tail.
- Acclimatization: 7 days week under laboratory conditions, after health examination.
- Diet: ad libitum
- Water : ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%):40-70%
- Air changes (per hr):10-15 air changes per hour
- Photoperiod (hrs dark / hrs light):12 hour light and 12 hour dark, music was palyed for approximately 8 hours during the light period.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- (PEG 300)
- Details on oral exposure:
- Test article preparation:
The test article was placed into a glass beaker on a tared Mettler PG 503-S balance and the vehicle (polyethylene glycol PEG 300) was added. A weight by volume dilution was prepared using a glass rod and magnetic stirrer as homogenizer. Homogeneity of the test article in the vehicle was maintained during treatment. The preparation was made shortly before each dosing. - Doses:
- Dose / kg body weight: 2000 mg
Application volume / kg body weight: 10 ml - No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: Four times during test day 1 and once daily during days 2-15
Body weight: On test day 1 (pre-administartion), 8 and 15.
Clinical signs: Each animal was examined for changing in appearance and behaviour four times during day 1, and once daily during days 2-15. All abnormalities were reccorded.
- Necropsy of survivors performed: yes Necropsy were performed by experineced prosectors. At the end of teh observation period all animals were sacrified by intrperitoneal injection of NARCOREN at a dose of at least 2.0ml/kg body weight (equivalent to at least mg sodium pentobarbitone/kg body weght)
- Other examinations performed: clinical signs, body weight. - Statistics:
- No statistical analysis was used as no deaths occured.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occured during the study
- Clinical signs:
- other: No clinical signs of toxicity were observed during the study period.
- Gross pathology:
- No macroscopic findings were observed at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The median lethal dose of FAT 41024/B after single administartion to rats of both sexes, observed over a period of 14 days, could not be estimated as no death occured.
LD50 is greater than 2000 mg/kg. - Executive summary:
The purpose of this study was to assess the acute oral toxicity of FAT 41024/B when administred by single oral gavage to rats, followed by an observation period of 14 days.
The experiment was performed according to the OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).
Two groups , each using three male or three female HanIbm: WIST (SPF) rats, were treated with FAT 41024/B at 2000 mg/kg by oral gavage.
The test article was suspended in vehicle (PEG 300) at a concentration of 0.2 g/ml and administred at a volume of 10 ml/kg. The animals were examined for clinical signs four times during test day 1 and once daily during test days 2 -15.
Mortaliy/Viability were reccorded together with clinical signs at the same time intervals. Body weight were recorded on day 1 prior to administartion and on day 8 and 15.
All animals were necropsied and examined macroscopically.
No deaths occured during the study.
No clinical signs of toxicity were observed during the study period.
The body weight of the animals was within the range commonly recorded for animals of this strain and age.
No macroscopic findings were observed at necropsy.
In conclusion, The median lethal dose of FAT 41024/B after single administartion to rats of both sexes, observed over a period of 14 days, could not be estimated as no death occured. LD50 is greater than 2000 mg/kg.
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