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Reaction mass of lithium sodium hydrogen 4-amino-6-({5-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-sulfonatophenyl}diazenyl)-5-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate and lithium sodium hydrogen 4-amino-6-({5-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-sulfonatophenyl}diazenyl)-5-hydroxy-3-{[4-(vinylsulfonyl)phenyl]diazenyl}naphthalene-2,7-disulfonate
EC number: 941-533-7 | CAS number: -
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18-07-1986 to 15-08-1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Lithium sodium hydrogen 4-amino-6-(5-(5-chloro-2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
- EC Number:
- 401-560-2
- EC Name:
- Lithium sodium hydrogen 4-amino-6-(5-(5-chloro-2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
- Cas Number:
- 108624-00-6
- Molecular formula:
- C28H(21-x-y)ClF2Li(x)N8Na(y)O16S5
- IUPAC Name:
- Lithium sodium hydrogen-4-amino-6-(5-(5-chloro-2,6-difluoropyrimidine-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Reactive Blue FC 05717
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: males - 126 g (115-137 g), females - 115 g (108-128 g)
- Housing: in Makrolon-Kafigen Type II cages
- Diet (e.g. ad libitum): Altromin 1324 pellets
- Water (e.g. ad libitum): ad libitum
DETAILS OF FOOD AND WATER QUALITY:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22°C
- Humidity (%): 50%
- Photoperiod (hrs dark / hrs light): 12:12
IN-LIFE DATES: 18-07-1986 to 15-08-1986
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Due to the good dispersibility of reactive blue FC 05717 in water in the concentration range used, a homogeneous distribution of the test suspension was obtained in the formulations. The test substance was administered to the rats via oral gavage. The test substance suspension was found to be stable for 48 h once prepared.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- All the test concentrations were analytically verified at least once during the study.
- Duration of treatment / exposure:
- 28 d
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 40 mg/kg bw/day (nominal)
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- six rats per sex per dose
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- The animals were regularly observed, weighed and the feed intake determined.
- Sacrifice and pathology:
- At the end of treatment, hematological and clinical-chemical investigations were carried out as well as organ weights (testes, liver, kidneys, adrenal glands). Heart, testes, liver, lung, spleen, kidney, adrenal, and other macroscopically abnormally altered organs/tissues were histopathologically examined.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- The relative liver weight in 1000 mg/kg/day females were significantly increased compared to controls. Although the absolute liver weight in these females were also elevated but there was no statistical significance.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- All animals at 1000 mg/kg/day presented a blue coloration of the visible connective tissue, particularly in the skin area, dark blue kidneys and bluish gastrointestinal contents. Also, in the females of the highest dose, approximately 10% higher liver weight was observed which was interpreted by the authors as a sign of a non-specific adaptation due to increased metabolic activity.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no treatment-related systemic effects observed
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the systemic NOAEL of the test substance in rats was considered to be 1000 mg/kg/day.
- Executive summary:
A study was conducted to determine the oral repeated dose toxicity of the test substance in rats according to OECD Guideline 407 and EU method B.7, in compliance with GLP. Male and female Wistar rats (6/sex/dose) were administered the following concentrations via oral gavage (suspended in water, at a constant volume of 10 mL/kg): 0, 40, 200 and 1000 mg/kg bw/day. Mortality, clinical signs, body weight and food consumption were recorded daily. At necropsy, blood samples were collected for haematology and clinical chemistry investigations. Also, a gross macroscopical examination was conducted, and organs were weighed. Routine histopathological examination was performed on the major organs such as heart, liver, kidneys, testes, adrenals, spleen, lungs etc. No treatment-related clinical signs of toxicity were observed. There were no treatment-related adverse effects on the body weight, food consumption, hematological and clinical biochemistry examinations. All animals at 1000 mg/kg bw/day presented a blue coloration of the visible connective tissue, particularly in the skin area, dark blue kidneys and bluish gastrointestinal contents. This was attributed to the inherent colour of the test substance. Also, in the females of the highest dose, approximately 10% higher liver weight was observed which was interpreted by the authors as a sign of a non-specific adaptation due to increased metabolic activity. Under the study conditions, the systemic NOAEL of the test substance in rats was considered to be 1000 mg/kg bw/day (Schmidt and Sander, 1988).
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