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Diss Factsheets
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EC number: 201-280-9 | CAS number: 80-46-6
- 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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Peer review publication describing two acute inhalation studies that were performed following the basic principles of OECD guideline 433, but neither adherence to the guidelines nor GLP status is claimed.
1) Five male and five female rats were exposed to a saturated vapour of p-tert butyl phenol for 6 hours
2) Five male and five female rats were exposed to a dynamically generated dust aerosol for 4 hours. - GLP compliance:
- no
- Test type:
- fixed concentration procedure
Test material
- Reference substance name:
- 4-tert-butylphenol
- EC Number:
- 202-679-0
- EC Name:
- 4-tert-butylphenol
- Cas Number:
- 98-54-4
- Molecular formula:
- C10H14O
- IUPAC Name:
- 4-tert-butylphenol
- Test material form:
- solid: flakes
- Details on test material:
- - Name of test material (as cited in study report): p-tertiary butylphenol
- Molecular formula (if other than submission substance): C10H14O
- Molecular weight (if other than submission substance): 150.21 g/mol
- Physical state: solid white flakes
- Analytical purity: 99.9%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Zivic Miller Laboratories inc, Zelionople, PA, USA and Harlan Sprague Dawley inc, Indianapolis, IN, USA.
- Weight at study initiation: 200-300 g
- Acclimation period: 5 days
- Photoperiod (hrs dark / hrs light): 12hr light and dark cycle
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: plexiglass chamber
- Exposure chamber volume: 120 litre
- Source and rate of air: filter compressed air carried dust into chamber
- System of generating particulates/aerosols: dust aerosols were generated by melting flakes in a flask at 110 degreesC
- Method of particle size determination: determined with a TSI model APS 3300 aerodynamic particle sizer
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): calculated by probit analysis. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5600 mg/m^3 of PTBP dust aerosol
- No. of animals per sex per dose:
- 5 males, 5 females.
- Control animals:
- not specified
- Statistics:
- None
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 600 mg/m³ air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- 1 male and 1 female rat died within 1 to 2 days, a mortality rate of 20%.
- Clinical signs:
- other: Clinical signs observed in this group of animals on the day of exposure and up to 7 days post-exposure included signs of mucosal irritation (perinasal, perioral, and periocular encrustation) and signs of respiratory distress (audible respiration, gasping
- Body weight:
- A loss of mean body weight was observed for both sexes on day 7, but body weight gains were exhibited by day 14.
- Gross pathology:
- Upon necropsy, dark red or purple discoloration of the lungs and/or kidneys was observed in the two rats that died, but no macroscopic lesions
were observed in rats that survived until study end.
Applicant's summary and conclusion
- Interpretation of results:
- sligthly toxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the high exposure conditions for 4hours, and despite the observed clinical signs, the material is not considered irritating to the respiratory tract (Decision based on RAC meeting, RAC/M/21/2012).
LC50 >5600 mg/m^3 - Executive summary:
Under the high exposure conditions for 4 hours, the test item was not acutely toxic; LC50 >5600 mg/m^3.
Clinical signs of mucosal irritation (perinasal, perioral, and periocular encrustation) and signs of respiratory distress (audible respiration, gasping, and a decreased respiration rate) were observed, but could not be confirmed during histopathology. These findings are considered to reflect physical or mechanical effects triggered by the high dosage. Despite these findings p-tert-butylphenol is not classified as respiratory irritant based on the decision made by the Committee for Risk Assessment (2012, RAC/M/21/2012).
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