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Diss Factsheets
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EC number: 701-365-5 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14. Dec. 1987 to 30. Sep 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
- Objective of study:
- absorption
- distribution
- excretion
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.7485 (Metabolism and Pharmacokinetics)
- Deviations:
- yes
- Remarks:
- metabolism determined in separate study
- GLP compliance:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- bisphenyl-U-14C
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 160 to 230 g
- Fasting period before study: -
- Housing: single (excretion) 2/cage (plasma levels, exhalation)
- Individual metabolism cages: yes (excretion) / no (plasma levels, exhalation)
- Diet: Altromin 1321 ad libitum
- Water: tap ad libitum
- Acclimation period: -
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 26
- Humidity (%): 30 to 50
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): -
IN-LIFE DATES: From: 14. Dec To: 24. Dec. 1987
23. Sep. To: 26. Sep. 1988
Administration / exposure
- Route of administration:
- other: oral gavage and intravenous
- Vehicle:
- other: water and NaCl
- Details on exposure:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): - oral: 10 mg/kg bw
- IV: 1 mg/kg bw
- concentration (if solution): - oral: 2 mg/g in aqua bidest
- IV: 0.3 mg/g in NaCl solution
- Duration and frequency of treatment / exposure:
- single dose
Doses / concentrations
- Remarks:
- Doses / Concentrations:
p.o.: 10 mg/kg body weight (nominal) - Concentration: 2 mg/g solution
i.v.: 1 mg/kg body weight (nominal) - Concentration: 0.3 mg/g solution
- No. of animals per sex per dose / concentration:
- Exhalation: 2
Plasma levels: 5
Excretion/remaining concentration p.o.: 5
Excretion i.v.: 3 - Control animals:
- other: one rat
- Positive control reference chemical:
- not examined
- Details on dosing and sampling:
- - Tissues and body fluids sampled: urine, faeces, blood, plasma, exhalate, tissues (spleen, stomach, small intestines, liver, kidneys, gonads, heart, lungs, skeletal muscle, subcutaneous fat, retroperitoneal fat, brain, eyes)
- Time and frequency of sampling:
- Blood sampling (tip of tail): 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 24, 32, 48, 72, 96, 120, 144, 168 h after test item administration
- Urine sampling: in polyethylen bottles 0 -2, 2 -4, 4 -8, 8 -24, 24 -48, 48 -72, 72 -96, 96 -120, 120 -144, 144 -168 h after test item administration
- Feces sampling: in glass vessels: 0 - 24, 24 -48, 48 -72, 72 -96, 96 -120, 120 -144, 144 -168 h after test item administration
- Organ/tissue sampling: directly after sacrifice - 7 days after test item administration
- Exhaled air: continuous aspiration at 0.2 m³/h
- Method type(s) for detection: Liquid scintillation counting
- Limits of detection and quantification: determination of blank value - Statistics:
- no data
Results and discussion
- Preliminary studies:
- NA
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- oral: 28.6 %
- Details on distribution in tissues:
- Blood: 0.25 µg equivalent/mL
Liver: 0.18 µg equivalent/g
Kidneys: 0.10 µg equivalent/g
All other organs: <0.1 µg equivalent/g
In sum 0.28 % of the administered dose; with mean values of 0.13 % in the blood and 0.10 % in the liver
- Details on excretion:
- Oral administration:
Excretion mainly via feces: 83.71 % of the administered dose
Renal excretion: 14.79 % of the administered dose
Bi-phasic elimination
no excretion by exhalation
Intravenous administration:
Main excretion renal: 51.72 % - bi-phasic
Fecal excretion: 26.5 %
Metabolite characterisation studies
- Metabolites identified:
- no
- Details on metabolites:
- see metabolism study HOE 88.1064
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
Incomplete absorption (ca. 28.6 %) after oral administration. About 85 % of the administered dose were excreted via feces and about 15 % via urine. The highest doses of radioactivity were found in blood and liver, 7 days after test item administration (about 0.28 % of the administered dose together with all other organs). After intravenous administration, about 52 % of the radioactivity were found in urine within 3 days after test item administration. - Executive summary:
The kinetics of [14]C-labeled the test substance was investigated in 5 male rats after oral gavage of 10 mg/kg body weight. For assessment of the absorption rate after oral gavage, one group of 3 rats were treated intravenously with 1 mg/kg bw.
The mean absorption rate was 28.6 % - determined by comparison of the renal excretion after oral and IV administration. The slow increase of radioactivity resulted in similar Cmax of 0.7 to 0.8 µg equivalent/g after 5.6 hours in plasma and 21 hours in blood. T1/2 were 5 and 34 hours in plasma and about 8 days in blood, leading to the assumption of of binding of the test substance to, presumably, erythrocytes.
After oral administration, excretion of radioactivity was mainly via feces (80 % to 88 % within 7 days); renal excretion was about 11 % to 18 % in a bi-phasic manner with half-times of 4 to 7 hours and 40 to 69 hours, respectively.
The highest remaining concentration after 7 days was found in blood (0.25 µg eq/mL) and liver (0.18 µg eq/g). Test substance levels in kidneys (0.1 µg eq/g and other tissues were lower. Totally, 0.28 % of the administered dose were found in blood and tissues. The mean over-all recovery rate was 99 % of the administered dose.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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