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EC number: 262-911-1 | CAS number: 61698-32-6
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 06 October 2021 to April 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted according to the OECD TG 423 without any deviation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 December 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspection date (French COFRAC): January 5-7, 2021 / Opinion (GIPC): 26 July 2021
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 4,5-bis(hydroxymethyl)-2-phenyl-1H-imidazole
- EC Number:
- 262-911-1
- EC Name:
- 4,5-bis(hydroxymethyl)-2-phenyl-1H-imidazole
- Cas Number:
- 61698-32-6
- Molecular formula:
- C11H12N2O2
- IUPAC Name:
- [4-(hydroxymethyl)-2-phenyl-1H-imidazol-5-yl]methanol
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: white to light-pink powder
- Storage: Keep away from heat and sources of ignition. Store in tightly closed container. Store in a well-ventilated place. Store in a cool, dark place.
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, in a dry place
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: stable under storage conditions. No analytical monitoring during the study.
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: No analytical monitoring during the study.
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: Olive oil was chosen as it produced the most suitable formulation at the requested concentration for the preparations.
- Reactivity of the test material with the incubation material used (e.g. plastic ware): none reported.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): The preparations were stirred using a vortex to obtain thick yellow solutions just before the administration
- Preliminary purification step (if any): none
- Final concentration of a dissolved solid, stock liquid or gel: 0.3 or 2 g in q.s. 10 mL.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- SPF Caw
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (F-69210 Saint-Germain-Nuelles)
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks old
- Weight at study initiation: 179-216 g on Day 0
- Fasting period before study: Food was removed on day 1 and then redistributed 4 hours after the test item administration.
- Housing: by group of three in solid-bottomed clear polycarbonate cages with a stainless-steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week.
- Historical data: available
- Diet (e.g. ad libitum): ad libitum (ENVIGO – 2014 & 2016)
- Water (e.g. ad libitum): ad libitum (tap-water from public distribution system)
- Acclimation period: at least 5 days
- Microbiological status when known: no contamination. Analysis carried out once every six months by Bureau veritas - Eurofins (FRANCE).
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 12 October 2021 To: 24 November 2021
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.3 or 2 g in vehicle
- Amount of vehicle (if gavage): q.s. 10 mL
- Justification for choice of vehicle: Olive oil was chosen as it produced the most suitable formulation at the requested concentration for the preparations. Distilled water was tested first as vehicle but the test item was immiscible in distilled water.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD
- Rationale for the selection of the starting dose: as per OECD TG 423 recommendation, when there is no information on the substance to be tested, for animal welfare reasons, it is recommended to use the starting dose of 300 mg/kg bw. - Doses:
- 300 (females) and 2000 mg/kg bw (females)
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions 30 minutes, 1 hour ± 6 minutes, 3 hours ± 30 minutes, 4 hours ± 30 minutes, 24 and 48 hours ± 2 hours after administration of the test item and continued daily for 14 days.
The animals were weighed on day D0 (just before administering the test item) then on day 2, day 7, and day 14.
- Necropsy of survivors performed: yes (gross necropsy)
- Clinical signs including body weight: yes
- Other examinations performed: not required - Statistics:
- None
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One mortality was noted in an animal treated at the dose of 2000 mg/kg body weight 6 days after the treatment (1/6). In the absence of clinical signs and the presence of cannibalism clues, this mortality can not be attributable to the test item.
- Clinical signs:
- other:
- Body weight:
- other body weight observations
- Remarks:
- The body weight evolution of the animals remained normal during the study.
- Gross pathology:
- The macroscopic examination of the animals did not reveal treatment related changes.
The macroscopical examination of the animal that died during the study (unrelated to test item administration) revealed a stomach filled with air, a thinned wall with an orange coloration, associated with a cellular lysis of duodenum, jejunum, ileum, caecum and colon. - Other findings:
- None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Oral LD50 Cut-off (Females) = 5000 mg/kg bw.
- Executive summary:
An acute oral toxicity study was conducted according to the OECD TG 423 and in compliance with GLP. The test item in olive oil was administered to a group of 6 8-weeks old female Sprague Dawley rats at the dose of 300 mg/kg body weight, then of 6 female Sprague Dawley rats at the dose of 2000 mg/kg body weight. The animals were observed for 14 days.
At 300 mg/kg bw, no mortality was noted in animals. No clinical signs related to the administration of the test item were observed during the study. The body weight evolution of the animals remained normal during the study. The macroscopic examination of the animals at the end of the study revealed a thinning of proventricular wall (3/6).
At 2000 mg/kg bw, one mortality was noted in an animal treated at the dose of 2000 mg/kg bw 6 days after the treatment (1/6). In the absence of clinical signs and the presence of cannibalism clues, this mortality can not be attributable to the test item. The macroscopical examination of this animal revealed a stomach filled with air, a thinned wall with an orange coloration, associated with a cellular lysis of duodenum, jejunum, ileum, caecum and colon.
No clinical signs related to the administration of the test item were observed during the study. The body weight evolution of the animals remained normal during the study. The macroscopic examination of the other animals did not reveal treatment related changes.
Oral LD50 Cut-off (Females) = 5000 mg/kg bw.
Under the test conditions, the test item does not have to be classified according to the Regulation EC No. 1272/2008 (CLP) and to the Globally Harmonized System of classification and labelling of chemicals (GHS).
This study is acceptable and satisfies the requirements for acute oral toxicity testing (OECD 423) in the rats.
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