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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Nov 19 - Dec 10, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Commission of the European Communities - EEC Directive 79-831, Annex V, Part B, Toxicological Methods of Annex VIII, Teratogenicity Test. Official Journal of the European Communities L 133/24-26, May 30, 1988.
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
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
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, Versuchstierzucht GmbH in 33178 Borchen
- Age at study initiation: appr. 9 weeks
- Weight at study initiation: 166 (154 - 178) g
- Fasting period before study: no
- Housing: individually under conventional conditions in Makrolon cages (type III) on softwood granulate specially manufactured for housing of animals
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 23 °C
- Humidity (%): 47 - 65 %
- Photoperiod (hrs dark / hrs light): 12 hours /12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- VEHICLE
- Concentration in vehicle: 20 %
- Amount of vehicle (if gavage): 100 mL
- Lot/batch no. (if required): --
- Purity: distilled - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- - Impregnation procedure: [artificial insemination / purchased timed pregnant / cohoused]
- M/F ratio per cage: 4 f / 1 m
- Length of cohabitation: overnight
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of gestation
- Any other deviations from standard protocol: no - Duration of treatment / exposure:
- treatment on 10 consecutive days from the 6th to the 15th day post conception
- Frequency of treatment:
- daily
- Duration of test:
- 20 days
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: on days 0, 3, and 6 p.c., and then daily until the end of the study.
FOOD CONSUMPTION AND COMPOUND INTAKE: Yes
- Food consumption was determined once a week (on days 6, 10, 15, and 20) by weighing the unconsumed food.
WATER CONSUMPTION AND COMPOUND INTAKE: Yes
- Water consumption was determined on days 3, 6, 9, 12, 15, 18, and 20 by weighing the water not consumed.
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day #20
The fetuses were delivered by Cesarean section on the 20th day p.c. and were examined for macroscopic malformations. About 2/3 of them were examined for skeletal and 1/3 for organ malformations. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: 1/3
- Skeletal examinations: Yes: 2/3 - Statistics:
- Standard statistical methods have been applied for data processing.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- 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:
- not examined
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- Water consumption in group 2 was increased during the treatment period and further until day 18 p.c.
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- not examined
- Total litter losses by resorption:
- not examined
- Early or late resorptions:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Complete, early, and late resorptions in group 2 were within the spontaneous range.
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not examined
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not examined - Changes in number of pregnant:
- no effects observed
- Other effects:
- no effects observed
- Details on maternal toxic effects:
- Maternal toxic effects: no effects
Details on maternal toxic effects:
All dams were clinically normal and none of the rats died.
Food consumption was normal, but water consumption in group 2 was increased during the treatment period and further until day 18 p.c.
Body weight was not negatively affected by treatment.
23 rats in group 1 (control) and 24 rats in group 2 (treatment) became pregnant.
The numbers of corpora lutea and live fetuses in group 2 corresponded to those in group 1. The number of implantations was reduced. Since implantation had been completed at the beginning of treatment, this finding is not substance related and, thus, irrelevant.
Complete, early, and late resorptions in group 2 were within the spontaneous range. No dead fetuses were found.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not examined - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- not examined
- Changes in postnatal survival:
- not examined
- External malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- At external examination one fetus with anemia was observed in group 1 (control).
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- not examined
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects: no effects
Details on embryotoxic / teratogenic effects:
Fetal weights were normal.
No runts were seen.
Sex distribution was normal.
At external examination one fetus with anemia was observed in group 1 (control).
No other abnormal findings were seen at external examination, evisceration, skeleton staining and after transverse section.
The skeletal examinations gave no indication of damage.
Effect levels (fetuses)
open allclose all
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- > 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: embryotoxicity
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- > 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Apart from the increased water consumption, Phenylbenzimidazole sulfonic acid (Na-salt) did not reveal maternally toxic effects and was neither embryotoxic nor teratogenic at the limit dose of 1000 mg/kg bw/day.
- Executive summary:
Study design
The teratogenic potential of Phenylbenzimidazole sulfonic acid (Na-salt) was investigated in Wistar rats after oral administration in a limit test. The test item was administered orally by gavage to 25 mated Wistar rats daily from day 6 through to day 15 post coitum at the limit dose level of 1000 mg/kg bw/day. A control group of 25 animals was dosed with the vehicle alone (water). All females were sacrificed on day 20 post coitum and the fetuses were removed by Caesarean section and examined for macroscopic malformations. About 2/3 of them were examined for skeletal and 1/3 for organ malformations.
Results
All females survived until scheduled necropsy. No signs of discomfort or clinical symptoms were observed. Mean food consumption and mean body weight was not affected by treatment with the test item in the dose group. In the dose group water consumption was increased during the treatment period and further until day 18 post coitum. 23 rat in the control group and 24 rats in the dose group became pregnant. The numbers of corpora lutea and live fetuses in the dose group corresponded to those in the control animals. Complete, early and late resorptions in the dose group were within the spontaneous range. No dead fetuses were recognized.
No effects on fetal body weights were noted. No test-item-related effects on fetal sex ratio were noted in the dose group. During the external examination of the fetuses, no test item-related abnormal findings were noted. No test item-related abnormalities were noted during visceral examination of fetuses. No abnormalities, which were considered to be test item-related, were noted during examination of fetal skeleton.
Conclusion
Apart from the increased water consumption, Phenylbenzimidazole sulfonic acid (Na-salt) did not reveal maternally toxic effects and was neither embryotoxic nor teratogenic at the limit dose of 1000 mg/kg bw/day.
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