Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 248-502-0 | CAS number: 27503-81-7
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11/1992 - 4/1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- GLP Study with excellent study design and documentation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
- Objective of study:
- distribution
- toxicokinetics
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 85-1 (Metabolism and Pharmacokinetics)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-phenyl-1H-benzimidazole-5-sulphonic acid
- EC Number:
- 248-502-0
- EC Name:
- 2-phenyl-1H-benzimidazole-5-sulphonic acid
- Cas Number:
- 27503-81-7
- Molecular formula:
- C13H10N2O3S
- IUPAC Name:
- 2-phenyl-1H-benzimidazole-5-sulphonic acid
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14 C
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
The test was performed in pregnant Wistar rats.
- Source: WINKELMANN, Borchen
- Age at study initiation: adult
- Weight at study initiation: 241- 296 g
- Fasting period before study: no
- Housing: conventionally in Makrolon cages type M III (WOETHO, Emmendingen)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one week after delivery
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22 °C
- Humidity (%): 50 - 60 %
- Photoperiod (hrs dark / hrs light): 12 / 12 hours
Administration / exposure
- Route of administration:
- other: iv and oral
- Vehicle:
- water
- Details on exposure:
- The chemical dose was 1 mg/kg for iv injection and 1000 mg/kg for po administration. The radioactive dose was 2 MBq/kg.
- Duration and frequency of treatment / exposure:
- The rats received the dissolved substance as a single dose both intravenously and orally. Iv injection was into one of the caudal veins, oral administration was by gavage using a stainless-steel infusion cannula (AKU-FIRM Cat. No. 1464/2).
Doses / concentrations
- Remarks:
- Doses / Concentrations:
The administration volume was 0.15 ml per 100 g body weight for both modes of administration.
single po: 1000 mg/kg
single iv: 1 mg/kg
- No. of animals per sex per dose / concentration:
- single po:
single iv: 1 mg/kg - Control animals:
- no
- Details on study design:
- - Rationale for animal assignment (if not random): random
- Details on dosing and sampling:
- The rats received the dissolved substance as a single dose both intravenously and orally. Iv injection was into one of the caudal veins, oral administration was by gavage using a stainless-steel infusion cannula (AKU-FIRM Cat. No. 1464/2).
The administration volume was 0.15 ml per 100 g body weight for both modes of administration.
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- 14C - peak concentration reached after 15 min after oral administration
- Type:
- distribution
- Results:
- after iv administration, elimination from plasma: half-life 0.4 h
- Type:
- distribution
- Results:
- liver and kidneys exhibited the highest concentrations
- Type:
- distribution
- Results:
- lowest concentrations of all organs and tissues were measured in the fetuses, i.e. the placental barrier was very poorly penetrated by the test item
- Type:
- excretion
- Results:
- 66 % via kidney after iv administration
- Type:
- excretion
- Results:
- after oral administration 2.5% of the dose was found in the urine within the collection period of 48 hours
- Type:
- excretion
- Results:
- after both modes of administration, the dose had been excreted after 48 hours
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- After single iv injection, the 14C-radioactivity was eliminated from the plasma with an apparent half-life of 0.4 hours. After oral administration the peak 14C-concentrations were already reached after 15 min, indicating a rapid absorption from the gastrointestinal tract.
- Details on distribution in tissues:
- Both after iv and oral administration, liver and kidneys exhibited the highest concentrations. The lowest concentrations of all organs and tissues were measured in the foetuses, i.e. the placental barrier was very poorly penetrated by the test item.
- Details on excretion:
- The iv injected radioactivity was predominantly (about 66 %) excreted via the kidneys. After oral administration 2.5 % of the dose was found in the urine within the collection period of 48 hours. Since no radioactivity was present in the bodies of the rats (residual radioactivity) after both modes of administration, it can be inferred that the dose had been excreted completely during the interval 0 to 48 hours. Based on the comparison of the AUCs and the excretion data after iv and oral administration it can be concluded that 3 – 4 % of the dose had been absorbed from the gastrointestinal tract.
Metabolite characterisation studies
- Metabolites identified:
- no
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study it can be concluded that there is no bioaccumulation potential after oral and iv administration of the test item in rats.
- Executive summary:
Study Design
The pharmacokinetics of 14C-labelled Phenylbenzimidazole sulfonic acid sodium salt was investigated after single iv injection (dose: 1 mg/kg bw) and oral administration (dose: 1000 mg/kg bw) in pregnant Wistar rats (day 18 of gestation).
Results
After single iv injection, the 14C-radioactivity was eliminated from the plasma with an apparent half-life of 0.4 hours. After oral administration the peak 14C-concentrations were already reached after 15 min, indicating a rapid absorption from the gastrointestinal tract.
Both after iv and oral administration, liver and kidneys exhibited the highest concentrations. The lowest concentrations of all organs and tissues were measured in the foetuses, i.e. the placental barrier was very poorly penetrated by the test item.
The iv injected radioactivity was predominantly (about 66 %) excreted via the kidneys. After oral administration 2.5 % of the dose was found in the urine within the collection period of 48 hours. Since no radioactivity was present in the bodies of the rats (residual radioactivity) after both modes of administration, it can be inferred that the dose had been excreted completely during the interval 0 to 48 hours. Based on the comparison of the AUCs and the excretion data after iv and oral administration it can be concluded that 3 – 4 % of the dose had been absorbed from the gastrointestinal tract.
Conclusion
Based on the results of this study it can be concluded that there is no bioaccumulation potential after oral and iv administration of the test item in rats.
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.