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Diss Factsheets
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EC number: 203-632-7 | CAS number: 108-95-2
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study meets scientific standards with acceptable restrictions (partly limited documentation, low number of animals).
Data source
Reference
- Reference Type:
- publication
- Title:
- Local and systemic effects following application of dilute solutions of phenol in water and in Camphor-liquid petrolatum on the skin of animals
- Author:
- Deichmann WB, Miller T, Roberts JB
- Year:
- 1 950
- Bibliographic source:
- Arch Ind Hyg Occ Med 2: 454-461
Materials and methods
- Principles of method if other than guideline:
- Local and systemic effects following repeated dermal application of aqueous solutions of phenol were studied in rabbits.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Phenol
- EC Number:
- 203-632-7
- EC Name:
- Phenol
- Cas Number:
- 108-95-2
- Molecular formula:
- C6H6O
- IUPAC Name:
- phenol
- Details on test material:
- Reagent grade.
No further data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: albino, no further data
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No further details
Administration / exposure
- Type of coverage:
- other: open (n=2) and bandaged (n=2), no further data
- Vehicle:
- water
- Details on exposure:
- See details on study design.
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 18 days
- Frequency of treatment:
- 5 h per day, 5 days per week for totally 18 days
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
1.18, 2.37, 3.56, 4.75, 5.93, and 7.12% phenol
Basis:
other: nominal concentration
- Remarks:
- Doses / Concentrations:
130, 260, 390, 520, 650, and 780 mg/kg bw/day
Basis:
other: based on an assumed body weight of 3 kg
- No. of animals per sex per dose:
- 4 animals (unknown sex) per concentration
- Control animals:
- not specified
- Details on study design:
- Albino rabbits were immobilized in the supine position and the hair was clipped from the abdomen, (repeated once a week throughout the experiment). Four rabbits were treated with each phenol concentration, 2 of which were bandaged (not at the 2 high dose levels); exposed skin area 10-15 cm2; to keep the area of the belly continuously moistened the initial dose (for each concentration) was 5 ml, followed by 2 ml every 20 min. Animals were treated for 5 h (total amount applied was 33 ml) on each of 5 consecutive days of a week for a total of 18 days. After a 5 hour period of skin contact, the bandage (n=2) was removed and materials were washed from the skin of bandaged and unbandaged animals with soap and water.
- Positive control:
- No
Examinations
- Observations and examinations performed and frequency:
- Local and systemic effects were recorded daily during and after each dermal exposure.
- Sacrifice and pathology:
- No data
- Other examinations:
- No data
- Statistics:
- No data
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- The 1.18 and 2.37 per cent phenol in aqueous solutions produced no signs of local irritation, while systemic effects were limited to occasional mild tremors in animals exposed to 2.37%. Eighteen applications of a 3.56% phenol in aqueous solution produced local and systemic effects: mild degree of hyperemia during each of the 5 hours exposures (particularly apparent in the bandaged animals disappeared after washing) and systemic effects like mild tremors noted from time to time during exposure. The 4.75% phenol induced more severe local and systemic effects: tremors became apparent in all rabbits about 1 h after the start of each exposure. Prominent hyperkeratosis was found in 1 out of 4 animals followed by breaking of the skin, with hemorrhages along the cracking edges. At 5.93 and 7.12 per cent phenol the rabbits showed impressive local changes and from moderate to severe signs uf systemic intoxication. One rabbit died after the sixth exposure to the high concentration.
No further data were documented.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 130 mg/kg bw/day
- Sex:
- not specified
- Basis for effect level:
- other: systemic effects
- Dose descriptor:
- LOAEL
- Effect level:
- 260 mg/kg bw/day
- Sex:
- not specified
- Basis for effect level:
- other: systemic effects (e.g. tremor)
- Dose descriptor:
- conc. level: NOAEC
- Effect level:
- 2.37 other: % in vehicle
- Sex:
- not specified
- Basis for effect level:
- other: no local effects
- Dose descriptor:
- conc. level: LOAEC
- Effect level:
- 3.56 other: % in vehicle
- Sex:
- not specified
- Basis for effect level:
- other: local effects (hyperemia)
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Systemic effects: NOAEL 130 mg/kg bw/day (1.18%) and LOAEL 260 mg/kg bw/day (2.37%).
Local effects: NOAEC 2.37% (260 mg/kg bw/day) and LOAEC 3.56% (390 mg/kg bw/day).
Lethal effects at 780 mg/kg bw/day
Applicant's summary and conclusion
- Conclusions:
- In rabbits the repeated dermal application of 260 mg/kg bw/day resulted in systemic effects, the NOAEL was 130 mg/kg bw/day. The LOAEC for local effects was 3.56% aqueous solution and the NOAEC 2.37%.
- Executive summary:
The study meets scientific standards with acceptable restrictions (partly limited documentation, low number of animals).
Four albino rabbits per dose level (n=2 at the 2 highest doses) received repeated dermal application 5 days per week for 18 days. The daily exposure duration was 5 hours. The phenol concentrations of test solutions were 1.18, 2.37, 3.56, 4.75, 5.93, and 7.12% in water corresponding to systemic dose levels of 130, 260, 390, 520, 650, and 780 mg/kg bw/day (totally 33 ml of the test substance applied within 5 h). Systemic effects like tremor were detected at 260 mg/kg bw/day, mild irritant effects at a concentration of 3.56% and severe local effects at 4.75%. Mortality (presumably due to systemic effects) was reported at 780 mg/kg bw/day.
Conclusion: In rabbits the repeated dermal application of 260 mg/kg bw/day resulted in systemic effects, the NOAEL was 130 mg/kg bw/day. The LOAEC for local effects was 3.56% aqueous solution and the NOAEC 2.37%.
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