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Diss Factsheets
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EC number: 202-859-9 | CAS number: 100-51-6
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study on carcinogenicity (supervised by NTP); no data on hematology, clinical chemistry or urinalysis
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD Guideline 451 (Carcinogenicity Studies)
- GLP compliance:
- yes
- 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:
- phenylmethanol
- Details on test material:
- - Name of test material (as cited in study report): Benzyl alcohol, NF grade (Stauffer Chemical Co., Westport, Connecticut)
- Purity 99 %
- Lot/batch No.: 4T 215P1
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: F344/N rats
- Source: Charles River Breeding Laboratories (Portage, MI)
- Age at study initiation: 8-9 weeks
- Weight at study initiation (mean): males: 211-213 g; females: 145-150 g
- Housing: 5 per cage
- Diet ad libitum
- Water ad libitum
- Acclimation period: 26 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.9-31 (66-88 °F)
- Humidity (%): 20-80
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Administration volume: 5 ml/kg
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- extraction of benzyl alcohol with methanol followed by gas chromatographic analysis
- Duration of treatment / exposure:
- 103 weeks
- Frequency of treatment:
- once daily, 5 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
200, and 400 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 50
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: For dose selection results from previously conducted 2-week and 3-month studies were used. "Because of reductions in relative weight gain, deaths, and lesions of the brain, thymus, skeletal muscle, and kidney, doses selected for rats for the 2-year studies were 200 and 400 mg/kg benzyl alcohol, administered in corn oil by gavage, 5 days per week."
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes, all animals
- Time schedule: observed twice daily; clinical signs were recorded at least once per month.
BODY WEIGHT: Yes, all animals
- Time schedule for examinations: Body weights were recorded initially, once per week for the first 12 weeks of the studies and once per month thereafter.
CLINICAL PATHOLOGY: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, necropsies were performed on all animals
HISTOPATHOLOGY: Yes, complete histopathology was performed on all female rats and on vehicle control and on high dose male rats, on male rats that died before month 22 and male rats with gross lesions.
The following tissues were examined: adrenal glands, brain, cecum, clitoral or preputial gland, colon, costochondral junction, duodenum, esophagus, eyes, gross lesions and tissue masses with regional lymph nodes, heart, ileum, jejunum, kidneys, larynx, liver, lungs and bronchi, mammary gland, mandibular and mesenteric lymph nodes, nasal cavity and turbinates, oral cavity, pancreas, parathyroids, pharynx, pituitary gland, rectum, salivary glands, sciatic nerve, scrotal sac/tunica vaginalis/seminal vesicles/ prostate/epididymis/testes or ovaries/uterus, skin, spinal cord, spleen, sternebrae or vertebrae or femur including marrow, thigh muscle, thymus, thyroid gland, trachea, urinary bladder, and Zymbal gland; pituitary gland and testis examined for low dose male rats. - Other examinations:
- no further data
- Statistics:
- According to Kaplan and Meier, method of Cox (1972) and Tarone's (1975) life table test, indicential tumor analysis, Fisher's exact/Cochrane-Armitage trend analysis
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- BODY WEIGHTS AND CLINICAL SIGNS
Mean body weights of dosed and vehicle control male and female rats were generally comparable throughout the studies. No compound-related clinical signs were observed.
SURVIVAL
Survival in male rats was not affected by treatment (final survival rates: vehicle control 28/50, low dose: 27/50, high dose 24/50) but reduced survival of dosed female rats by half (final survival rates: vehicle control 36/50; low dose 18/50; high dose 17/50). Many of the early deaths were considered to be related to the gavage procedure.
NONNEOPLASTIC AND NEOPLASTIC LESIONS
Cited from NTP report: "No apparent compound-related non-neoplastic responses were observed. Dose-related negative trends in the incidences of anterior pituitary gland neoplasms were seen in female rats (vehicle control, 29/50; low dose, 17/47; high dose, 9/49)"....., which is an incidence of 58, 36, and 18 %, respectively. Historical incidence in NTP studies: 692/1654 (42 %).
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 400 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: based on the fact that body weight gains in male and female mice were not affected and compound-related clinical signs were not observed at this dose level; no apparent compound-related non-neoplastic findings at pathology/histopathology
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Cited from abstact of NTP report: "No apparent compound-related non-neoplastic responses were observed."
Applicant's summary and conclusion
- Executive summary:
In a study equivalent to OECD TG 451 (supervised by NTP) male and female F344/N rats received daily by gavage 0, 200 and 400 mg/kg bw/day benzyl alcohol diluted in corn oil for 104 weeks (5 days/week). No effect on body weight gain and and no compound-related clinical signs were observed throughout the study. Survival was reduce only for female rats, but in many cases deaths were attributed the gavage procedure. Gross necropsy and histopathology revealed no apparent compound-related non-neoplastic responses. Thus, 400 mg/kg can be considered a NOAEL from this study (NTP TR 343, 1989).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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