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Diss Factsheets
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EC number: 210-296-5 | CAS number: 612-16-8
- 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:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from collection of data.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Comparison of estimated daily intakes of flavouring substances with no-observed-effect levels
- Author:
- I.C. Munro, B. Danielewska-Nikiel
- Year:
- 2 006
- Bibliographic source:
- Food and Chemical Toxicology 44 (2006) 758–809
Materials and methods
- Principles of method if other than guideline:
- Benzyl alcohol is the parent compound and p-anisyl acetate is its alkoxy derivate and a metabolite. Based on this correlation, benzyl alcohol has been used as a read across.
Two years toxicity study was conducted to evaluate the chronic toxic nature of the test compound Benzyl alcohol. - GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Benzyl alcohol
- EC Number:
- 202-859-9
- EC Name:
- Benzyl alcohol
- Cas Number:
- 100-51-6
- Molecular formula:
- C7H8O
- IUPAC Name:
- Benzenemethanol
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Benzyl alcohol
- Molecular formula (if other than submission substance): C7-H8-O
- Molecular weight (if other than submission substance): 108.139 g/mol
- Substance type: Organic
- Physical state: No data available
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Benzyl alcohol
- Molecular formula (if other than submission substance): C7-H8-O
- Molecular weight (if other than submission substance): 108.139 g/mol
- Substance type: Organic
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data available
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- 0, 200 or 400 mg/Kg bw/day
- No. of animals per sex per dose:
- No data available
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule:
- Cage side observations checked in table [No.?] were included. Mortality was noted
DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule:
BODY WEIGHT: No data
- Time schedule for examinations:
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
FOOD EFFICIENCY: No data
- 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: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data - Time schedule for examinations:
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations:
- Dose groups that were examined:
HAEMATOLOGY: No data
- Time schedule for collection of blood: No data
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data
CLINICAL CHEMISTRY: No data
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data
URINALYSIS: No data
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked in table [No.?] were examined. No data
NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data
OTHER: No data - Sacrifice and pathology:
- No data available
- Other examinations:
- No data available
- Statistics:
- No data available
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- Mortality: In comparison to controls, a 50% reduction was observed in the survival of female rats at both dose levels; deaths were attributed to gavage error rather than to compound- related toxicity.
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 400 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects noted
- Remarks on result:
- other: No toxic effect observed.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The No Observed Effect Level (NOEL) for the test compound Benzyl alcohol (100-51-6)is considered to be 400 mg/Kg bw/day in rats by oral gavage.
- Executive summary:
Two years chronic toxicity study was conducted on rats to evaluate the toxic nature of the test compound Benzyl alcohol. The test substance was exposed to male and female rats at the concentration of 0, 200 or 400 mg/Kg bw/day by oral gavage. The animals were observed for mortality and clinical signs. No significant mortality or clinical sign observed. The No Observed Effect Level (NOEL) for the test compound Benzyl alcohol is considered to be 400 mg/Kg bw/day. Based on the results of the rat study a NOEL of 400 mg/kg body weight/day was selected for the calculation of the margin of safety of Benzyl alcohol
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