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EC number: 204-589-7 | CAS number: 122-99-6
- 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

Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- 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-phenoxyethan-1-ol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ORIENT BIO Inc. (322, Galmachi-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea)
- Age at administration: 9 - 10 weeks
- Weight at administration: 221 - 247 g (preliminary test); 231 - 233 g (main test)
- Fasting period before study:
- Housing: single animals in Polycarbonate cage(W 420 x L 270 x H 180 mm)
- Diet: rodent diet 1314 IRR[Altromin Spezialfutter GmbH & Co. KG(Im Seelenkamp 20, D-32791 Lage Postfach 11 20, D-32770 Lage)].
- Water (e.g. ad libitum): Public tap water were filtered and sterilized by ultraviolet light
- Acclimation period: more than 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.9 - 21.9
- Humidity (%): 46.3 - 55.4
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From 11 May 2021 To 04 June 2021
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 4 × 4 cm^2
- % coverage: approx. 10%
- Type of wrap if used: held in contact with the skin with a porous gauze dressing, non-irritating tape (Tegarderm, 3M) and adhesive band (Coban, 3M)
REMOVAL OF TEST SUBSTANCE
- Washing: gently wahsed with sterile distilled water
- Time after start of exposure: after 24h of application.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): based on the body weight measured right before administration - Duration of exposure:
- 24 hours
- Doses:
- Preliminary test: 200, 1000, 2000 mg/kg bw
Main test: 2000 mg/kg bw - No. of animals per sex per dose:
- Preliminary test: 1 animal/dose
Main test: 2 animals/dose - Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs: 0.5, 1, 2, 3, 4, 5 and 6 hours after administration and then once each day for 14 days.
Body weight: Day 0 (just before administration) and on Days 7 and 14 (before necropsy).
- Necropsy of survivors performed: yes
Results and discussion
- Preliminary study:
- No mortality and no clinical signs were observed in the animal treated with 200, 1000, 2000 mg/kg bw. Body weights developed normally an no remarkable necropsy findings were observed at any dose group tested.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality observed.
No. of dead animals/ total animals (preliminary + main test):
0/1 at 200 mg/kg bw
0/1 at 1000 mg/kg bw
0/3 at 2000 mg/kg bw - Gross pathology:
- No abnormal findings were observed during necrospy
Any other information on results incl. tables
- No dead animals were observed during the study period.
- No clinical signs related to test substance administration were observed.
- No abnormal body weight changes were observed.)
- No abnormal findings were observed during necrospy.
Applicant's summary and conclusion
- Executive summary:
The purpose of this study was to assess the toxicity of the test substance, 2-Phenoxyethanol following a single dermal administration to Sprague Dawley rats.
The dose levels of preliminary test were set at 200 mg/kg bw (Step 1), 1000 mg/kg bw (Step 2) and 2000 mg/kg bw (Step 3), and one female animal were used per dose group. The dose levels of the main test was set at 2000 mg/kg bw, based on the preliminary test findings and two female animals were used. The test substance was applied undiluted and uniformly over a clipped area (approx. 10% of total body surface) of the dorsal/flank area under occlusive conditions. All animals were monitored for clinical signs and body weight changes during the 14 days observation period after administration. They were subjected to gross necropsy at the end of the observation period.
No test substance-related dead animals and clinical signs were observed during the study period. No abnormal body weight changes related to the test substance administration were observed. At necropsy, there were no lesions caused by administration of the test substance.Based on the results of the acute dermal toxicity study in Sprague Dawley rats, the test substance was virtually non-toxic after single dermal administration and the LD50 was set at > 2000 mg/kg bw.
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