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EC number: 202-804-9 | CAS number: 99-96-7
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study which meets basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
- Principles of method if other than guideline:
- 4 hour inhalation, 5 male, 5 female, Sprague-Dawley rats
- GLP compliance:
- not specified
- Test type:
- fixed concentration procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 4-hydroxybenzoic acid
- EC Number:
- 202-804-9
- EC Name:
- 4-hydroxybenzoic acid
- Cas Number:
- 99-96-7
- Molecular formula:
- C7H6O3
- IUPAC Name:
- 4-hydroxybenzoic acid
- Details on test material:
- - Name of test material (as cited in study report): C-194
- Physical state: solid
- Analytical purity: 100%
Comment by the applicant:
Existing retained samples from batches of C-194 of 1980 were analytically rechecked. The identity was confirmed with a content of 4-HBA of approximately 100% (NMR analysis).
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: Charles River Breeding Laboratories, Wilmington, Massachusetts
- Weight at study initiation: males: 240-297g, females: 218-237g
- Fasting period before study: no
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: plexiglass exposure chamber
- Exposure chamber volume: 100 l
- Source and rate of air: dry air, flow rate 15 l per minute
- Method of conditioning air: Wright Dust Feeder
- Method of particle size determination: Casella Cascade Impactor
TEST ATMOSPHERE (if not tabulated)
- Nominal concentration: 7.91 mg/l
- Particle size distribution: average mass median diameter = 5.8µm +-2.3-3.3
- mean airborne concentration: 0.47 mg/l
- Temperature: 22 °C
- Mean relative humidity: 88% - Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 4 h
- Concentrations:
- 7.91 mg/l
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations (during exposure): before exposure, every 15 minutes during the first hour of exposure and hourly through termination
- Frequency of observations: hourly for 4 hours post-exposure
- Frequency of weighing: day 0 (prior to exposure), 1, 2, 4, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy examination
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- discriminating conc.
- Effect level:
- >= 0.47 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: effects of irritation of the inner surfaces of the respiratory tract observed, nominal concentration: 7.91 mg/L
- Mortality:
- no
- Clinical signs:
- other: Fur contaminated with test material, reduced activity, wet and/or matted fur, excessive salivation, rapid breathing, stained fur, mucoid nasal discharge, dried material around eyes, nose, mouth, walking on toes, body tremors, lack of grip, transient weig
- Body weight:
- weight losses in all male rats, body weight and body weight gain in the second week within the expectations
- Gross pathology:
- 5 male and 3 female showed foci and areas of lung discoloration (no histopathology).
Any other information on results incl. tables
Nominal concentration in the air: 7.91 mg/L.
Mean airborne testmaterial concentration: 0.47 mg/l,
Chamber distribution: at the inlet portal: 0.48 mg/L, at the outlet portal: 0.43 mg/L,
Average aerodynamic mass median diameter: 5.8 µm, standard deviation: 2.3 to 3.3 µm.
Chamber temperature: 22°C
Mean relative humidity: 88%.
Applicant's summary and conclusion
- Executive summary:
A 4 hour inhalation exposure to a dust of 4 -HBA at a nominal concentration of 7.91 mg/l (7910 mg/m³) with an aerodynamic mass median diameter of 5.8 micrometers with a geometric standard deviation range of 2.3 to 3.3 and a mean airborne concentration of 0.47 mg/l (470 mg/m³) did not produce mortality. The following test item related clinical symptoms were observed:
fur contaminated with test material, reduced activity, wet and/or matted fur, excessive salivation, rapid breathing, stained fur, mucoid nasal discharge, dried material around eyes, nose, mouth, walking on toes, body tremors, lack of grip, transient weight loses in male rats. During the 14 -day observation period persistent dry slight rales were observed predominantly in male rats.
At necropsy, 5 male and 3 female rats showed foci and areas of lung discoloration.
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