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EC number: 203-139-7 | CAS number: 103-73-1
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Hemolytic Activity of Ethylene Glycol Phenyl Ether (EGPE) in Rabbits
- Author:
- Breslin WJ, Phillips JE, Lomax LG, Bartels MJ, Dittenber DA, Calhoun LL, Miller RR.
- Year:
- 1 991
- Bibliographic source:
- FUNDAMENTAL AND APPLIED TOXICOLOGY 17, 466-48 1 (1991)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Subchronic dermal toxicity of 2-phenoxy ethanol was assessed in New Zealand White Rabbit in 90 days study period
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 2-phenoxyethanol
- EC Number:
- 204-589-7
- EC Name:
- 2-phenoxyethanol
- Cas Number:
- 122-99-6
- Molecular formula:
- C8H10O2
- IUPAC Name:
- 1-hydroxy-2-phenoxyethane
- Reference substance name:
- 2-phenoxy ethanol
- IUPAC Name:
- 2-phenoxy ethanol
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material : 2-phenoxyethanol
- Molecular formula : C8H10O2
- Molecular weight : 138.17
- Substance type : Organic
- Physical state : Liquid
- Impurities :1% (no data available regarding identity of impurities)
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Details on test animal
TEST ANIMALS
- Source: Hazleton-Dutchland, Denver, PA
- Age at study initiation: 5 months of age
- Housing: individually (in cages with wire floors)
- Diet (e.g. ad libitum): Certified Laboratory Rabbit Chow
- Water (e.g. ad libitum): Tap water (ad libitum)
- Acclimation period: 3 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 deg C
- Humidity (%): relative humidity at 50%
- Photoperiod (hrs dark / hrs light): 12 hr light: 12 hr dark photocycle
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Details on Dermal exposure
Dosing volume: approximately 0.05 to 0.50 ml/kg/day
2-phenoxyethanol was uniformly spread over a clipped area (approximately 10 X 15 cm) using a syringe and Hunt-tipped needle. The application site was reclipped as required during the study to keep it free of hair. An occlusive wrap of absorbent gauze and nonabsorbent cotton was placed over the application area and was held in place using an elastic jacket. The wraps and jackets were removed approximately 6 hr after each dose was applied. The backs of the rabbits were not wiped since no appreciable amount of test material was apparent at the site of application after the 6-hr exposure period. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days (13 weeks)
- Frequency of treatment:
- 5 days/week (6 hr/day)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0,50, 150,or 500 mg/kg/day
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 10 animals per sex per dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Ten New Zealand White rabbits/sex/group were treated with 0, 50, 150, or 500 mg/kg/day of undiluted 2-phenoxyethanol for 6 hr/day, 5 days/week, for 13 weeks by dermal route. Dosing volume was approximately 0.05 to 0.50 ml/kg/day and was adjusted weekly based upon body weight Control rabbits received 0.5 ml/kg/day distilled water.
Examinations
- Observations and examinations performed and frequency:
- Observations and examinations performed & frequency
BODY WEIGHT: Yes
Body weight observed
HAEMATOLOGY: Yes
Blood samples (approximately 7 ml) for hematology determinations were obtained from the auricular artery of all rabbits approximately 1 week prior to dosing and after 4 and 13 weeks of treatment. Samples for hematologic determinations were collected using vacuum tubes, and mixed with potassium EDTA anticoagulant. RBC, WBC, and PLAT counts, HGB concentration, PCV, and RBC indices (MCV, MCH, MCHQ were determined on all samples. Differential leukocyte and reticulocytes (RETICS) counts and RBC morphologic determinations were conducted on samples from all control and high dose group rabbits by direct microscopic examination of stained smears after 13 weeks of treatment only.
CLINICAL CHEMISTRY: Yes
Blood samples (approximately 7 ml) for clinical chemistry determinations were obtained from the auricular artery of all rabbits approximately 1 week prior to dosing and after 4 and 13 weeks of treatment.
Blood samples for clinical chemistry determinations were allowed to clot at 0-5 °C and serum was harvested by centrifugation. Alanine aminotransferase activity, aspartate aminotransferase activity, urea nitrogen, alkaline phosphatase activity, glucose, total protein, albumin, globulin, and total bilirubin were determined on all samples.
ORGAN WEIGHT: Yes
On the day following the last dermal application of 2-phenoxyethanol each rabbit was euthanatized with CO2, weighed and examined for gross pathological alterations. Brain, heart, liver, kidneys, and testes were weighed and relative organ weights (g/100 g body weight) were calculated. - Sacrifice and pathology:
- Sacrifice and pathology
HISTOPATHOLOGY: Yes
Sample of all organ systems and tissues were collected from each rabbit at necropsy and preserved in neutral, phosphate-buffered 10% formalin. All tissues collected from control and high dose animals were processed by conventional histological techniques, stained with hematoxylin and eosin and evaluated by light microscopy. - Statistics:
- Descriptive statistics (means and standard deviation) were evaluated for body weight, RBC indices, RBC Met-HGB, RBC GSH, RBC fragility, WBC differential count, serum EGPE, and PAA residue
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No overt signs of systemic toxicity (including hemoglobinuria) or early mortality of treated rabbits were noted over the 13-week dosing period.
- Dermal irritation:
- no effects observed
- Mortality:
- no mortality observed
- Description (incidence):
- No overt signs of systemic toxicity (including hemoglobinuria) or early mortality of treated rabbits were noted over the 13-week dosing period.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effects observed on Body weight
- 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:
- no effects observed
- Description (incidence and severity):
- No effects observed on Hematology
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No effects observed on clinical chemistry
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No effects observed on organ weights
- Gross pathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No gross or microscopic changes attributable to EGPE exposure were observed in any tissue examined.
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- Other effects:
The only potentially treatment-related effect was the sporadic observation of erythema and very slight-to-slight scaling of the skin at the site of test material application in male and female rabbits exposed to 500 mg EGPE/kg/day. However, as these effects were not associated with gross or histological changes in the skin they were not considered to be of toxicologic significance.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effects observed on Mortality, Body weight, organ weight, Clinical chemistry, hematology, histopathology
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEL of EGPE (i.e. 2-phenoxy ethanol) on New Zealand White rabbits in a 90 days dermal exposure study was considered to be 500 mg/kg/day.
- Executive summary:
In conclusion, dermal exposure of rabbits to high doses (500 mg/kg/day) EGPE(i.e.2-phenoxy ethanol)does not result in systemic toxicity. Other effects observed were not considered to be of toxicological significance.
Therefore, the NOAEL of EGPE was considered to be 500 mg/kg/day when administered dermally.
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