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EC number: 257-486-4 | CAS number: 51868-46-3
- 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
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Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21-01-1991 to 08-02-1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
- Objective of study:
- absorption
- distribution
- excretion
- metabolism
- Principles of method if other than guideline:
- The test substance was administered to Sprague-Dawley rats via oral gavage in corn oil in order to determine the extent of absorption, distribution,into different tissues and elimination through urine. Urine samples were analysed to determine the levels of the test substance and its primary metabolite.
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,2'-[[5-acetamido-4-[(2-bromo-4,6-dinitrophenyl)azo]-2-methoxyphenyl]imino]diethyl diacetate
- EC Number:
- 222-813-1
- EC Name:
- 2,2'-[[5-acetamido-4-[(2-bromo-4,6-dinitrophenyl)azo]-2-methoxyphenyl]imino]diethyl diacetate
- Cas Number:
- 3618-72-2
- Molecular formula:
- C23H25BrN6O10
- IUPAC Name:
- 2-{[2-(acetyloxy)ethyl]({4-[ (E)-2-(2-bromo-4,6-dinitrophenyl)diazen-1-yl]-5acetamido-2-methoxyphenyl})amino}ethyl acetate
- Details on test material:
- Disperse Blue 79:1 (Br)
CAS No. 3618-72-2
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- radiochemical purity 99%
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc., Portage, MI
- Age at study initiation: 7 weeks
- Housing: stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 h light:12 h dark
IN-LIFE DATES: From: 21-01-1991 To: 08-02-1991
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The unlabelled test substance was first dissolved in small volume of acetone and then the radio-labelled test substance was added by volume to it. Corn oil was then weighed in the vial containing both the forms of the test substance. A small stirring bar was placed in the vial and a stream of nitrogen was bubbled into the suspension overnight to evaporate the acetone.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 500 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose / concentration:
- four per sex per dose group
- Control animals:
- no
- Details on study design:
- The test substance was administered to Sprague-Dawley rats via oral gavage in corn oil in order to determine the extent of absorption, disposition into different tissues and the extent of elimination through urine. In addition, the urine samples were analysed to determine the levels of the test substance and its primary metabolite.
- Details on dosing and sampling:
- Four rats per sex per dose group, kept individually in Roth-type metabolism cages for acclimation and fasting for 15 h, were administered the test substance dissolved in corn oil at the target concentrations of 50 and 500 mg/kg/day at a dose volume of 4 mL/kg and a target radioactivity of 10-15 µCi.
Urine samples were collected at 6, 12, 24, 48, 72 and 96 h post-dosing under dry ice. Fecal samples were collected at room temperature at same intervals. Room air was trapped through the metabolism cages at approximately 500 mL/min and the expired 14CO2 was trapped at 12, 24, 48, 72 and 96 h post-dosing and stored cold until analysis.Volatile organic metabolites were not collected.
At 96 h post-dosing, the animals were sacrificed by overdose of methoxyflurane and exsanguination. Blood collected at termination was separated into plasma and RBCs for analysis. The metabolism cages were washed with 1% trisodium phosphate and an acetone/water rinse. These wash and rinse samples were analysed for inclusion in the material balance.
The pelt was removed from the carcass, prior to removal of the organs. The liver, kidney, bone marrow from femur, brain, peritoneal fat, heart, lung, urinary bladder, spleen, upper GI tract and its contents, testes, ovaries and uterus were isolated and collected for analysis. The remaining carcass was weighed and stored cold until analysis.
Results and discussion
Main ADME resultsopen allclose all
- Type:
- other: Material balance
- Results:
- The overall recovery of the administered dose was 98+/-2.1% for males and 92.5+/-2.6% for female animals.
- Type:
- absorption
- Results:
- The test substance was not absorbed substantially through oral gavage administration.
- Type:
- distribution
- Results:
- The test substance was not found to be distributed to the tissues to a major extent following oral administration.
- Type:
- metabolism
- Results:
- The test substance was substantially cleared from the GI tract and does not appear to be extensively metabolised following oral administration.
- Type:
- excretion
- Results:
- The majority (greater than 85%) of the oral dose of the test substance was excreted in the faeces and less than 6% was recovered in the urine during the 96 h post dose period.
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- By 24 h post dosing, approximately 86% (males) and 74% (females) of the administered dose was excreted in the faeces. Additionally, approximately 3% of the dose was recovered in urine in the initial 24 h for either sex. Therefore, it is evident that the test substance was not substantially absorbed when orally administered to rats.
- Details on distribution in tissues:
- Less than 0.15% (males) and 0.04% (females) of the test substance was detected in the tissues 96 h post administration. Liver was the only tissue that had greater than 0.02% of the administered dose for either sex. Less than 0.01% of the administered dose was recovered from the femur bone marrow. From these results, it is evident that, the test substance was not distributed significantly into different tissues.
- Details on excretion:
- By 24 h post dosing, approximately 86% (males) and 74% (females) of the administered dose was excreted in the faeces. Additionally, approximately 3% of the dose was recovered in the urine in the initial 24 h for either sex. The majority of the elimination of the radioactivity was virtually complete by 48 h post-dosing. Expired CO2 was less than 0.1% for males and 0.1% for females.
Metabolite characterisation studies
- Metabolites identified:
- no
- Details on metabolites:
- Analysis of pooled samples from animals of each sex in each dose group showed an unidentified metabolite which effectively accounted for all (>90%) of the detectable radioactivity in the urine samples. The suspected metabolite BDNA did not appear in any of the urine samples.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the study, the test substance was not substantially absorbed through oral gavage. Majority of the administered dose was excreted through feces and only a minor proportion of the dose was excreted through urine. The test substance was not distributed to different tissues and most of the test substance was eliminated unchanged.
- Executive summary:
A study was conducted to determine the toxicokinetic behaviour of the test substance in rats according to an internal protocol of the test facility. The test substance (dissolved in corn oil) was administered to groups of fasted rats at 50 and 500 mg/kg/day through oral gavage at a dose volume of 4 mL/kg and a target radioactivity of 10-15 µCi. Urine and faecal samples were collected at regular intervals until 96 h post dosing. At 96 h post-dosing, the animals were sacrificed by overdose of methoxyflurane and exsanguination. Blood collected at termination was separated into plasma and RBCs for analysis. The liver, kidney, bone marrow from femur, brain, peritoneal fat, heart, lung, urinary bladder, spleen, upper GI tract and its contents, testes, ovaries and uterus were isolated and collected for analysis. The remaining carcass was weighed and stored cold until analysis. By 24 h post dosing, approximately 86% (males) and 74% (females) of the administered dose was excreted in the faeces. Additionally, approximately 3% of the dose was recovered in the urine in the initial 24 h for either sex. The majority of the elimination of the radioactivity was virtually complete by 48 h post-dosing. Expired CO2 was less than 0.1% for males and 0.1% for females. Less than 0.15% (males) and 0.04% (females) were detected in the tissues 96 h post administration. Liver was the only tissue that had greater than 0.02% of the administered dose for either sex. Less than 0.01% of the administered dose was recovered from the femur bone marrow. Analysis of pooled samples from animals of each sex in each dose group showed an unidentified metabolite which effectively accounted for all (>90%) of the detectable radioactivity in the urine samples. The suspected metabolite BDNA did not appear in any of the urine samples. Under the conditions of the study, the test substance was not substantially absorbed through oral gavage. The majority of the administered dose was excreted through feces and only a minor proportion of the dose was excreted through urine. The test substance was not distributed to different tissues and most of the test substance was eliminated unchanged (Frantz, 1991).
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