Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 200-456-2 | CAS number: 60-12-8
- 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: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- A 90-day study of phenylethyl alcohol in the rat
- Author:
- Owston, E., Lough, R., Opdyke, D.L.,
- Year:
- 1 981
- Bibliographic source:
- Food and Cosmetics Toxicology 19 (6), 713–715
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-phenylethanol
- EC Number:
- 200-456-2
- EC Name:
- 2-phenylethanol
- Cas Number:
- 60-12-8
- Molecular formula:
- C8H10O
- IUPAC Name:
- 2-phenylethanol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Phenylethyl alcohol - 99.9% purity, supplied by the Research Institute for Fragrance Materials, Inc
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals - The animals used were Charles River CD albino rats purchased from Charles River Breeding Laboratories, Wilmington, MA. On day one of treatment, the rats were 7-9 weeks old and weighed 185-316g (males) and 158-257g (females).
Environmental conditions - The animals were housed in wire-mesh-bottomed stainless-steel cages in rooms maintained at 21 +/- 2°C and 50 +/- 5% relative humidity with a 12-hour light/dark cycle.
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- The test material was applied by inunction to the shaved dorsa of the rats. The animals were treated with 0.25, 0.50, 1.00 and 2.00 ml/kg body weight.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Dose concentrations: 0.25, 0.50, 1.00 and 2.00 ml/kg body weight.
Equivalent to: 255, 510, 1020, 2040 mg/kg bw based on density of 1.0202
- No. of animals per sex per dose:
- 15 males and 15 females
- Control animals:
- yes
- Details on study design:
- The test material was applied by inunction to the shaved dorsa of the rats. The four treatment groups each consisted of 15 males and 15 females and were treated with 0.25, 0.50, 1.00 and 2.00 ml/kg body weight respectively. A fifth group of 30 males and 30 females (cage control) was maintained unshaven and untreated as a reference.
Examinations
- Observations and examinations performed and frequency:
- Animals were observed daily for change in appearance and behaviour. Body weights and food consumption were measured weekly. Funduscopic and biomicroscopic examinations were performed on the eyes of all animals before treatment and at week 13. Blood samples were collected at weeks 6 and 13 from 5 animals of each sex from each group and the following determinations made: haemoglobin, haematocrit, erythrocyte count and total and differential leucocyte counts. Biochemical analysis on the same samples included: fasting serum glucose, blood urea nitrogen, alkaline phosphates, glucose, blood urea nitrogen, alkaline phosphatase, glutamic-oxalacetic transaminase and glutamic-pyruvic transaminase. Urine samples were collected at week 6 and 13 and volume, colour, transparency, odour, specific gravity, pH, bilirubin, protein, glucose, ketones and occult blood and for a microscopic examination of the urinary sediment.
- Sacrifice and pathology:
- The rats were asphyxiated by carbon dioxide after 90 days. Autopsies were carried out on and the brain, kidneys, liver and gonads were dissected free of fat and weighed. Microscopic examination was carried out on the adrenals, brain, heart, kidneys, liver, lung and bronchi, mesenteric lymph node, pituitary, sternum, spinal cord, testes with epididymides, ovaries, spleen, urinary bladder and nerve with muscle from all control rats and those exposed to the highest dose. Sternal bone-marrow smears from the same groups were also examined.
- Statistics:
- Differences between the control group and each of the treated groups were tested for statistical significance using Student's t test (P < 0.05).
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- The body weight among animals treated with 1.00 or 2.00 ml/kg bw were significantly decreased after 1 week of treatment and remained so for the duration of the experiment.
The mean body-weight gains of both sexes were depressed among the treated animals in a dose-dependent fashion and the decreases were statistically significant at 1.00 and 2.00 ml/kg. - Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- There was a significant decrease in haemoglobin concentration and white blood cell count among male rats dosed with 2.00 ml/kg.
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant increases in the relative weights of the brain, kidneys and gonads occurred among rats of both sexes given the dose 2.00 ml/kg.
Relative liver weights were increased at all doses among the females and both absolute and relative liver weights were decreased among the males given 1.00 ml/kg. This was not confirmed at 2.00 ml/kg and thus was not considered to be toxicologically significant. - Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Gross pathological changes in the lungs and stomach of animals killed after 90 days of treatment were seen in all groups including the controls. Petechiae on the gastric mucosa were frequently observed in all groups. The incidence of these findings was not related to dosage.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 510 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: decreased body weight and organ effects at higher treatment levels.
Applicant's summary and conclusion
- Conclusions:
- The no-effect level for 2-phenylethanol is 0.5 ml/kg/day (or 510 mg/kg bw/day).
- Executive summary:
2 -phenylethanol was applied by inunction to the shaved dorsa of groups of 15 male and 15 female rats. The doses were 0.25, 0.50, 1.00 and 2.00 ml/kg body weight daily for 90 days. There were no abnormalities or mortalities during the treatment period. The body weights of the rats treated with 1.00 and 2.00 ml/kg bw decreased significantly. There was a significant decrease in haemoglobin concentration and white blood cell count among male rats dosed with 2.00 ml/kg. Significant increases in the relative weights of the brain, kidneys and gonads occurred among rats of both sexes given the dose 2.00 ml/kg.
Relative liver weights were increased at all doses among the females and both absolute and relative liver weights were decreased among the males given 1.00 ml/kg. This was not confirmed at 2.00 ml/kg and thus was not considered to be toxicologically significant. Gross pathological changes in the lungs and stomach of animals killed after 90 days of treatment were seen in all groups including the controls. Petechiae on the gastric mucosa were frequently observed in all groups, the incidence of these findings was not related to dosage.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.