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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1983
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Effects of various exposure levels of 2-phenylethanol on fetal development and survival in long-Evans Rats
- Author:
- R. F. Mankes , R. LeFevre , H. Bates & R. Abraham
- Year:
- 1 983
- Bibliographic source:
- Journal of Toxicology and Environmental Health, 12, 235-244
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- 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
Test animals
- Species:
- rat
- Strain:
- Long-Evans
- Details on test animals or test system and environmental conditions:
- The test animals were sourceed from Blue Spruce Farm in Altamont, NY. After mating the females were housed in wire-topped plastic cages. Food and water were available ad ibitum.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- Aqueous suspensions of 2-phenyIethanol were freshly prepared, and daily doses of 20 ml/kg were given by gavage to female Long-Evans rats based on their current body weights. The exposure period was from d 6 to 15 of gestation, the so-called "critical
period" of organogenesis in the rat. Distilled water served as the control. - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- The presence of vaginal sperm was defined as d 0 of gestation. Rats that did not mate and those that did not become pregnant were excluded from the analysis.
- Duration of treatment / exposure:
- The exposure period was from day 6 to 15 of gestation.
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Group I - 19 pregnant rats as controls
- Dose / conc.:
- 432 mg/kg bw/day (nominal)
- Remarks:
- Group II - 5 pregnant rats
- Dose / conc.:
- 43 mg/kg bw/day (nominal)
- Remarks:
- Group III - 7 pregnant rats
- Dose / conc.:
- 4.3 mg/kg bw/day (nominal)
- Remarks:
- Group IV - 7 pregnant rats
- No. of animals per sex per dose:
- See above.
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- The exposure levels were chosen as fractional doses (24, 2.4, or 0.24%) of the available LD50 values for phenylethanol, 1 log interval apart (Owston et al., 1981). The large number of pregnant rats were assigned to group 1 controls to account for intralitter variability.
Examinations
- Maternal examinations:
- Dams were observed daily for signs of toxicity and lethality. Maternal body weights were recorded on d 0-15 and 20 of gestation.
- Ovaries and uterine content:
- The following observations and weights were recorded at day 20: total uterine weight, total litter weight, individual pup weights, number of live pups, stillbirths, résorptions, implantation sites, sex distribution, crown-rump length, and number of corpora lutea.
- Fetal examinations:
- All live pups were examined for gross malformations at birth: soft-tissue (internal) defects were evaluated by the method of Wilson (1965), while skeletal variations were detected by the method of McLeod (1980).
- Statistics:
- All data generated in the course of the study were entered, archived, and statistically analyzed on a DEC System 10 computer. Statistical analyses of the data were performed according to the methods of Dixon and Brown (1977), using both the litter and fetus as experimental units. The f-squared (BMDP3D) analysis was used to compare uterine weights, litter weights, pup weights, litter sizes and crown-rump length. The two-way frequency count routine (BMDP1F) was applied to embryonic deaths (résorptions), total of dead and malformed, and incidences of malformations, as described earlier (Mankes et al., 1981, 1982).
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Signs of severe maternal intoxication were observed immediately following ingestion of 2-phenylethanol at 432 mg/kg bw. These signs persisted overnight and were observed after each daily dose. Lower dose levels (43 or 4.3 mg/kg bw) were asymptomatic.
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- One dam (of group II) died from intratracheal intubation.
- Body weight and weight changes:
- not specified
- Food efficiency:
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Maternal developmental toxicity
- Dead fetuses:
- effects observed, treatment-related
- Description (incidence and severity):
- 100% of the Group 2 pups (432 mg/kg bw) were dead or malformated.
- Changes in pregnancy duration:
- not specified
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 43 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- LOAEL
- Effect level:
- 4.3 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Reduction in number of live offspring:
- effects observed, treatment-related
Applicant's summary and conclusion
- Conclusions:
- The highest no observed adverse effect level (NOAEL) for maternal toxicity is 43 mg/kg/bw/day. The NOEAL for development, teratogenecy and fetotoxicity is 4.3 mg/kg/bw/day.
- Executive summary:
Pregnant Long-Evans rats were treated with 4.3, 43, 430 mg/kg/day 2 -phenylethanol from day 6 to day 15 of gestation. Dams were monitored daily for signs of toxicity and lethality and all pups were examined for malformation. The results showed that the highest dosage (430 mg/kg/day) caused maternal toxicity. Examination of the offspring showed that all dosage levels caused malformations. Fetal death rate showed an increase at 43 mg/kg/day at 18% compared to 6% in the control group. The highest no observed adverse effect level (NOAEL) for maternal toxicity is 43 mg/kg/bw/day. The NOEAL for development, teratogenecy and fetotoxicity is 4.3 mg/kg/bw/day.
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