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EC number: 202-219-9 | CAS number: 93-11-8
- 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:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- data is from secondary literature.
Data source
Reference
- Reference Type:
- other: secondary source
- Title:
- OPINION ON PHENYLBENZIMIDAZOLE SULFONIC ACID AND ITS SALTS
- Author:
- HEALTH AND CONSUMER PROTECTION DIRECTORATE GENERAL
- Year:
- 2 006
- Bibliographic source:
- OPINION ON PHENYLBENZIMIDAZOLE SULFONIC ACID AND ITS SALTS- SCCP/1056/06
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Principles of method if other than guideline:
- The objective of this study was to evaluate the subchronic toxicity of the given test substance in Wistar rats.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Ensulizole
- IUPAC Name:
- Ensulizole
- 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-sulfonic acid
- Test material form:
- solid
- Details on test material:
- - IUPAC name:Phenylbenzimidazole Sulfonic Acid
- Molecular formula: C13H10N2O3S
- Molecular weight: 274.299g/mol
- Substance type: organic
-Physical state: solid
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- W.74 (SPF)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 5% aqueous tylose
- Details on oral exposure:
- VEHICLE
- Justification for use and choice of vehicle (if other than water): 5% aqueous tylose
- Concentration in vehicle: 0, 100, 330 and 1000 mg/kg bw
- Lot/batch no. (if required): 414 512
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg body weight. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 7 days/week
Doses / concentrations
- Remarks:
- Dose levels: 0, 100, 330 and 1000 mg/kg bw
- No. of animals per sex per dose:
- Test: 30 animals [15♂, 15♀]/ dose group)
Control: 30 animals [15♂, 15♀] - Control animals:
- yes
- Details on study design:
- No data
- Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Observations were carried out daily on all animals.
- Cage side observations checked: Mortality was observed.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Not specified
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Not specified
- Food consumption were recorded weekly.
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Not specified
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: recorded weekly.
OPHTHALMOSCOPIC EXAMINATION: Not specified
- Time schedule for examinations: Not specified
- Dose groups that were examined: Not specified
HAEMATOLOGY: Yes
- Time schedule for collection of blood: week 6 and at termination of the study
- Anaesthetic used for blood collection: Not specified
- Animals fasted: Not specified
- How many animals: 5 males and 5 females of each group.
- Parameters checked in table [No.?] were examined. No data available
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: week 6 and at termination of the study
- Animals fasted: Not specified
- How many animals: 5 males and 5 females of each group.
- Parameters checked in table [No.?] were examined. No data available
URINALYSIS: Yes
- Time schedule for collection of urine: week 6 and at termination of the study
- Metabolism cages used for collection of urine: Not specified
- Animals fasted: Not specified
- Parameters checked in table [No.?] were examined.No data available
NEUROBEHAVIOURAL EXAMINATION: Not specified
- Time schedule for examinations:Not specified
- Dose groups that were examined:Not specified
- Battery of functions tested: sensory activity / grip strength / motor activity / other:Not specified
IMMUNOLOGY: Not specified
- Time schedule for examinations: Not specified
- How many animals: Not specified
- Dose groups that were examined: Not specified
- Parameters checked in table [No.?] were examined.Not specified
OTHER: No data available - Sacrifice and pathology:
- Anatomic pathology examinations comprised organ weights, necropsy, histopathology.
GROSS PATHOLOGY: Yes
Organ weights (thymus, thyroid, heart, lung, liver, spleen, kidneys, adrenals, testes,ovaries) were determined for all animals. All animals were also subjected to macroscopic inspection after necropsy.
HISTOPATHOLOGY: Yes
Histopathological examination was carried out in 5 male and 5 female animals of the control- and the 1000 mg/kg-group. The organs looked at were:heart, lung, liver, pancreas, spleen, kidneys, pituitary, thyroid, thymus, adrenals,testes/epididymes, prostate gland, seminal vesicles, ovaries, uterus, salivary gland (head),oesophagus, stomach, intestines (duodenum, jejunum, ileum, olon), lymph nodes, bladder, brain, eyes, aorta, trachea, skeletal muscles, bones, bone marrow). - Other examinations:
- No data
- Statistics:
- No data
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No clinical signs of toxicity were seen in any group.
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- Three mortalities (1♂, week 5, control group; 1♀, week 13, 330 mg/kg-group; 1♀, week 6, 1000 mg/kg-group) occurred intercurrently but were not substance related.
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Food consumption was the same in test and control groups.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Description (incidence and severity):
- Water consumption was the same in test and control groups.
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- Haematology results (total and differential blood count) of test animals did not differ from controls throughout the experiment.
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Clinico-chemical parameters of test animals did not differ from controls throughout the experiment except for protein content in serum in females of the 1000 mg/kg-group, which was increased as compared to controls.However, the level found was within the biological variability range on record for female rats of this age and was therefore not considered substance related.
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Differences in organ weights, if observable at all (e.g. spleen in ♀'s), were small and not dose dependent.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- Necropsy-findings in the animals which had died intercurrently, revealed no pathological changes attributable to the test substance. Neither did the animals which were sacrificed pursuant to protocol at the end of the study exhibit any such changes.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Histopathology did not reveal any organ change or –damage in any one of the dose groups.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical biochemistry
- clinical signs
- food consumption and compound intake
- gross pathology
- haematology
- histopathology: non-neoplastic
- mortality
- organ weights and organ / body weight ratios
- water consumption and compound intake
- Remarks on result:
- other: No toxic effect were observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- On the basis of the parameters examined, the NOAEL value was considered to be 1000 mg/kg/day in male and female rats for 13 weeks study by oral gavage.
- Executive summary:
The sub-chronic toxicity study was conducted by using the given test chemical as per OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents) in male and female Wistar rats at the concentration of 0, 100, 330 and 1000 mg/kgbw/day for 13 weeks via oral gavage route. The given test chemical was dissolved in 5% aqueous tylose and administered as 10 ml/kg bw via oral gavage route. Control animals received vehicle only. Animals were treated as given above and examined with respect to in-life-observations, clinical pathology and anatomic pathology. In-life-observations were carried out daily on all animals for mortalities and clinical signs of toxicity. Body weight and food-/water consumption were recorded weekly. Clinical pathology, viz. haematology, clinical chemistry and urinalysis, was performed in week 6 and at termination of the study using 5 males and 5 females of each group. Anatomic pathology examinations comprised organ weights, necropsy, histopathology. Organ weights (thymus, thyroid, heart, lung, liver, spleen, kidneys, adrenals, testes, ovaries) were determined for all animals. All animals were also subjected to macroscopic inspection after necropsy. Histopathological examination was carried out in 5 male and 5 female animals of the control- and the 1000 mg/kg-group. The organs looked at were: heart, lung, liver, pancreas, spleen, kidneys, pituitary, thyroid, thymus, adrenals, testes/epididymes, prostate gland, seminal vesicles, ovaries, uterus, salivary gland (head), oesophagus, stomach, intestines (duodenum, jejunum, ileum, olon), lymph nodes, bladder, brain, eyes, aorta, trachea, skeletal muscles, bones, bone marrow).
Three mortalities (1♂, week 5, control group; 1♀, week 13, 330 mg/kg-group; 1♀, week 6, 1000 mg/kg-group) occurred intercurrently but were not substance related. No clinical signs of toxicity were seen in any group. Food- and water consumption were the same in test- and control groups. Haematology results (total and differential blood count) of test animals did not differ from controls throughout the experiment. The same holds for clinico-chemical parameters, except for protein content in serum in females of the 1000 mg/kg-group, which was increased as compared to controls. However, the level found was within the biological variability range on record for female rats of this age and was therefore not considered substance related. Necropsy-findings in the animals which had died intercurrently, revealed no pathological changes attributable to the test substance. Neither did the animals which were sacrificed pursuant to protocol at the end of the study exhibit any such changes.
Differences in organ weights, if observable at all (e.g. spleen in ♀'s), were small and not dose dependent. Histopathology did not reveal any organ change or –damage in any one of the dose groups.
Based on the above study, the toxicologically no adverse effect amount by repetitive oral administration of test substance for 13 weeks was observed and hence under this test condition NOAEL was considered to be1000 mg/kg bw/day.
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