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EC number: 200-073-0 | CAS number: 50-97-5
- 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
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- Flash point
- Auto flammability
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- 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
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- Endpoint summary
- Stability
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- 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
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- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
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- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 Oct 2016 - 02 Feb 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted in accordance with international guidelines and in accordance with GLP. All relevant validity criteria were met.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- Used for data analysis where dosing performed in the study is below 5000 mg/kg
- Deviations:
- yes
- Remarks:
- The pre-test body weight of Animal 4 exceeded + 20% of the mean pre-test body weights of the previously dosed animals. No impact on the study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- yes
- Remarks:
- The pre-test body weight of Animal 4 exceeded + 20% of the mean pre-test body weights of the previously dosed animals. No impact on the study.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- The pre-test body weight of Animal 4 exceeded + 20% of the mean pre-test body weights of the previously dosed animals. No impact on the study.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- α-phenyl-1H-benzimidazole-2-methanol
- EC Number:
- 200-073-0
- EC Name:
- α-phenyl-1H-benzimidazole-2-methanol
- Cas Number:
- 50-97-5
- Molecular formula:
- C14H12N2O
- IUPAC Name:
- α-phenyl-1H-benzimidazole-2-methanol
- Test material form:
- solid
- Details on test material:
- Storage Conditions:Stable at ambient temperature (10-30°C). Store in darkness; may be used/formulated in light.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Raleigh NC and Stone Ridge NY
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: body weight variation did not exceed ±20% of the mean body weight at the start of treatment
- Fasting period before study: yes
- Housing: Animals were individually housed in suspended wire-bottom cages that conform to the size recommendations in the Guide for the Care and Use of Laboratory Animals (National Research Council). Absorbent paper bedding, placed beneath the cage, changed at least three times per week.
- Diet (e.g. ad libitum): Fresh PMI Rat Chow (Diet #5012) will be available ad libitum except for 16 to 20 hours prior to dosing.
- Water (e.g. ad libitum): free access to mains drinking water
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Exact temperature was not indicated but both temperature and humidity was continuously recorded using automated recording device.
- Humidity (%): Exact temperature was not indicated but both temperature and humidity was continuously recorded using automated recording device.
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 : 12
IN-LIFE DATES: Not clarified in the study report
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- The test article was administered orally by syringe and a dosing needle on an mg/kg basis.
Initially, a single female Sprague Dawley rat was dosed orally with TX16352 at a dose level of 2000 mg/kg. Since the animal survived, four additional females were dosed at 2000 mg/kg. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Each animal was given single dose of 2.0 mL - 2.5 mL dose volume of 2000 mg/kg of the test item (i.e. animal 1&2: 20.mL, animal 3&5 : 2.2 mL and animal 4 received 2.5 mL)
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0.25, 1, 2 and 4 hours after dosing then daily thereafter for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight - Statistics:
- not required
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No deaths reported
- Clinical signs:
- other: Piloerection, partially chewed food, chromorhinorrhea, few feces, and localized hair loss (side of neck) were observed.
- Gross pathology:
- No abnormalities noted at necropsy.
Any other information on results incl. tables
Table 1: Number of animals dead (and with evident toxicity)
Dose (mg/kg bw
|
Mortality (# dead / total) |
Time range of deaths (hours)
|
Number with evident toxicity (# / total)
|
||||
Male |
Female |
Combined |
Male |
Female |
Combined |
||
|
- |
0/5 |
0/5 |
n/a |
- |
0/5 |
0/5 |
Table 2. Systemic Observation
Dose |
2000 mg/kg |
||||
Animal ID/sex |
1F |
2F |
3F |
4F |
5F |
Time period |
|
|
|
|
|
15 minutes |
|
S |
|
|
|
Hour 1 |
|
F,S |
|
F |
|
Hour 2 |
|
R |
|
F |
F |
Hour 4 |
|
F |
1 |
|
|
Day 1 |
F |
F,S,X |
1 |
|
|
Day 2 |
|
F,S,X |
1 |
|
|
Day 3 |
|
|
1 |
|
|
Day 4 |
|
|
1 |
|
|
Day 5 |
|
|
|
2 |
|
Day 6 |
|
|
|
2 |
|
Day 7 |
|
|
|
|
|
Day 8 |
|
|
|
|
|
Day 9 |
|
|
|
|
|
Day 10 |
2 |
|
|
|
|
Day 11 |
|
|
|
|
|
Day 12 |
|
|
|
|
|
Day 13 |
2 |
|
|
|
|
Day 14 |
|
|
|
|
|
No entry indicates animal appeared normal at that observation period. 1 = Hair loss: left side of the neck 2 = Partially chewed food on pan liner F = Piloerection S = Chromorhinorrhea X = Few feces
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System Unclassified).
- Executive summary:
OECD 425 (2017) - In an acute oral toxicity study, a group of fasted, 8-12 week old female Wistar rats were given a single oral dose of TX16352 at a single dose rate of 2000 mg/kg bw (limit test) and observed for 14 days.
In the absence of mortality during the observation period, the oral LD50 was estimated to be greater than 2000 mg/kg bw.
In addition, there were no treatment related clinical signs, necropsy findings or changes in body weight observed in any of the individuals.
In conclusion, the test item, TX16352 did not meet the criteria for classification according to Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixture.
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