Registration Dossier
Registration Dossier
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: 203-227-5 | CAS number: 104-68-7
- 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:
- key study
- Study period:
- 23 Oct 1985 - 08 Oct 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study.
- Justification for type of information:
- Read Across to an analogue based on structural similarity. An analogue justification is attached to section 13 of the dataset.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
- Reference Type:
- publication
- Title:
- Hemolytic activity of ethylene glycol phenyl ether (EGPE) in rabbits
- Author:
- Breslin, W.J. et al.
- Year:
- 1 991
- Bibliographic source:
- Fund Appl Toxicol 17:466-481
Materials and methods
- Principles of method if other than guideline:
- No guideline mentioned in the report.
However, study is equivalent or similar to OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study) with minor deviations regarding weight at study initiation:
Males: about 3250 g; Females: about 3380 g - GLP compliance:
- yes
- Remarks:
- according to FDA and EPA GLP Practice regulation
- 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:
- 2-phenoxyethanol
- Details on test material:
- - Name of test material (as cited in study report): Ethylene glycol phenyl ether
- Physical state: colorless liquid
- Analytical purity: 99.9%
- Lot/batch No.: 53 (C44172)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton-Dutchland, Inc. Denver, Pennsylvania
- Age at study initiation: approx. 5-6 months
- Weight at study initiation: Males: about 3250 g; Females: about 3380 g
- Fasting period before study: none
- Housing: single
- Diet (e.g. ad libitum): 4 oz./day/animal (Certified Laboratory Rabbit Chow #5322, Ralston Purina Co., St. Louis, Missouri)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 21 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 20
- Humidity (%): approx. 50
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- TEST SITE
- Area of exposure: 10 x 15 cm on the back of each test animal.
- Type of wrap if used: Occlusive bandage of absorbent gauze and nonabsorbent cotton held in place using a Lycra/spandex jacket.
- Time intervals for shavings or clipplings: clipping periodically as required during the course of the study.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Dosing volume was approximately 0.05 to 0.50 ml/kg bw/day and was adjusted weekly based on body weight. Control rabbits received 0.5 ml/kg bw/day distilled water - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 6 hours per day, 5 days/week for 13 consecutive weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 150, 500 mg/kg bw/day
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, sham-exposed
- Details on study design:
- - Dose selection rationale: Results from previous studies
Examinations
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: The animals were examined daily for general state of health and clinical symptoms of toxicity.
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: The condition of the skin was assessed and recorded prior to each daily dose for the first two weeks and approx. weekly thereafter using a modified Draize scoring system (see attached background material).
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION: Yes, periodically (data were not presented in the report)
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: At end of study. In-situ examination of the eyes by a glass slide technique with fluorescent illumination
- Dose groups that were examined: All animals
HAEMATOLOGY: Yes
- Time schedule for collection of blood: 1 week prior to exposure (pre-exposure), 4 week interim, and at test termination.
- Anaesthetic used for blood collection: No
- Animals fasted: No
- How many animals: All animals
- Parameters checked in table were examined.
CLINICAL CHEMISTRY: Yes / No / No data
- Time schedule for collection of blood: 1 week prior to exposure (pre-exposure), 4 week interim, and at test termination
- Animals fasted: No
- How many animals: All animals
- Parameters checked in table were examined.
URINALYSIS: No - Sacrifice and pathology:
- GROSS PATHOLOGY: A complete set of organs was collected from each animal and was preserved in neutral phosphate-buffered 10% formalin. The lungs were infused with formalin to their approximate normal inspiratory volume whereas the nasal cavity was flushed with formalin via the pharyngeal duct to ensure rapid fixation of the tissues.
HISTOPATHOLOGY: A complete histopathological examination of tissues was conducted for the rabbits of the control and the high dose groups. For this purpose, tissues were prepared by conventional techniques, stained with Hematoxylin/Eosin and were evaluated by means of light microscopy. - Statistics:
- Body and organ weights, as well as hematological and clinical-chemical data were analyzed using Bartlett's test for equality of variances. Based on the outcome, a parametric or nonparametric analysis of variance was conducted, followed by Dunnett's test or the Wilcoxon rank-sum test with Bonferroni's correction. The critical level of significance was p < 0.05. Statistical outliers were identified by a sequential outlier test but were not excluded from analysis except for body weight.
Level of significance: see attached background material
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No overt signs of systemic toxicity
no mortalities at any dose
BODY WEIGHT AND WEIGHT GAIN
The mean body weights of male and female rabbits were not affected by treatment with 2-phenoxyethanol during the course of the study.
FOOD CONSUMPTION
Results on food consumption were not reported.
OPHTHALMOSCOPIC EXAMINATION
No findings were reported.
HAEMATOLOGY
No treatment-related effects could be evidenced.
CLINICAL CHEMISTRY
No treatment-related effects could be evidenced.
In fact, a statistically significant decrease in AST activity was reported for the females of the 150 mg/kg/d dose group after 4 weeks of treatment, whereas the males of the 50 mg/kg bw /d showed an increased ALT activity at study termination. However, these effects neither showed a dose-response relationship nor were they seen at the other sampling time points. Therefore, these effects were not considered to be treatment-related.
URINALYSIS
Not examined
ORGAN WEIGHTS
No toxicologically significant changes were observed in terminal body weights or absolute and relative organ weights. A statistical decrease in absolute liver weight was identified in female rabbits administered 50 mg/kg bw/day of test substance, but there was no dose-response relationship. Therefore, the statistically identified difference in liver weight was not considered to be treatment-related.
GROSS PATHOLOGY
There were no treatment-related gross pathological changes observed in either male or female rabbits. The few observations in these animals at necropsy were considered spontaneous changes typical of those expected in New Zealand White rabbits of this age. Likewise, there were no treatment-related lesions observed.
HISTOPATHOLOGY: NON-NEOPLASTIC
See attached background material
OTHER FINDINGS
The only potentially treatment-related effects were the sporadic occurrence of erythema (4 males) and the very slight to slight scaling of the skin at the application site (8 males and 9 females at week 7) in animals exposed to 500 mg/kg bw/day. Exfoliation was resolved in all but 2 females during weeks 9-13. As these observations were not associated with any gross or histological changes in the skin, they were not considered to be of toxicological significance.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
- Dose descriptor:
- LOAEL
- Effect level:
- > 500 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
No
overt signs of toxicity were noted in the animals. There were no deaths.
There was no significant effect of treatment on body or organ weights,
clinical chemistries, hematologic variables, or pathology. The only
potentially treatment-related effects was the sporadic observation of
erythema (4 males) and very slight to slight scaling of the skin at the
site of test material application (8 males and 9 females at week 7) in
animals exposed to 500 mg/kg bw/day.
Exfoliation was resolved in all but 2 females during weeks 9-13. As
these observations were not associated with any gross or histological
changes in the skin, they were not considered to be of toxicologic
significance.
For tables of results refer to attached background material
Applicant's summary and conclusion
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.
