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EC number: 221-761-7 | CAS number: 3228-02-2
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From September 24 to October 23, 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted according to OECD test Guideline No. 403 without any deviation.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP Compliance Programme (inspected on December 02, 2002/ signed on February 13, 2003)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 4-isopropyl-m-cresol
- EC Number:
- 221-761-7
- EC Name:
- 4-isopropyl-m-cresol
- Cas Number:
- 3228-02-2
- Molecular formula:
- C10H14O
- IUPAC Name:
- 4-isopropyl-m-cresol
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): Biosol
- Physical state: White crystalline Solid
- Storage condition of test material: Room temperature in the dark
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 (UK) Ltd, Margate, Kent.
- Age at study initiation: Approximately 8-12 weeks
- Weight at study initiation: 200-350 g
- Housing: Animals were housed in groups of five per sex in solid-floor polypropylene cages with stainless steel lids, furnished with softwood flakes and provided with environmental enrichment items: wooden chew blocks and cardboard "fun tunnels"
- Diet: Food (EU Rodent Diet 5LF2, IPS Limited, Wellingborough, Northants, UK), ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2°C
- Humidity: 55 ± 15%
- Air changes: 15 changes/hour
- Photoperiod: 12 hours dark / 12 hours light
IN-LIFE DATES: From September 24 to October 23, 2003
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: compressed air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Cylindrical exposure chamber; dynamic (continuous flow)
- Exposure chamber volume: Approximately 30 L (dimensions: 28 cm diameter x 50 cm high)
- Method of holding animals in test chamber: Each rat was individually held in a tapered, polycarbonate restraining tube fitted onto a single tier of the exposure chamber and sealed by rubber 'O' ring. Only the nose of each animal was exposed to the test atmosphere.
- Source and rate of air: Compressed air was supplied by an oil free compressor; chamber flow rate was maintained at 40 L/min providing 80 air changes per hour
- Method of conditioning air: Air was passed through a water trap and respiratory quality filters before it was introduced into the SAG 410.
- Atmosphere generation: A dust atmosphere was produced from the test material using a SAG 410 Solid Aerosol Generator (TOPAS GmbH, Dresden, Germany) located adjacent to the exposure chamber. The SAG 410 was connected to a metered compressed air supply.
- Method of particle size determination: The particle size of generated atmosphere inside the exposure chamber was determined three times during the exposure period using a Marple Personal Cascade Impactor (Schaefer Instruments Ltd, Oxon., UK).
- Temperature and relative humidity inside the exposure chamber was measured by an electronic thermometer/humidity meter located in a vacant part in the animal's breathing zone of the chamber and recorded every thirty minutes throughout the 4 hours exposure period.
- Exposure chamber oxygen concentration was measured by an electronic oxygen analyser (Servomex (UK) Ltd, Crowborough, East Sussex) located in a sampling part in the animal's breathing zone during each exposure period.
TEST ATMOSPHERE
- Brief description of analytical method used:
Gravimetric method: Air in the breathing zone was drawn through glass fibre filters (Gelman type A/E 25 mm) and the employed filters weighed before and after sampling. The difference in the two weights, divided by the volume of atmosphere sampled, gave the actual chamber concentration.
- Samples taken from breathing zone: Yes
TEST ATMOSPHERE
- See the table 7.2.2/1 and 7.2.2/1
- Prior to the start of the study, test material atmospheres were generated within the exposure chamber. During this characterisation period, extensive work was performed in an attempt to achieve a sustainable atmosphere at maximum concentration. This included alternative grinding techniques and varying the generation system. No significant improvement could be made to the achieved atmosphere concentrations or particle size distributions and therefore, the concentration achieved is considered the maximum attainable. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Gravimetric method
- Duration of exposure:
- 4 h
- Concentrations:
- Nominal concentration: 77.0 mg/L
Mean maximum attainable atmosphere concentration: 1.41 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: All animals were observed for clinical signs at hourly intervals during exposure, immediately on removal from the restraining tubes at the end of exposure, one hour after termination of exposure and subsequently once daily for fourteen days. All animals were observed for mortality throughout the study period.
- Frequency of weighing: Individual bodyweights were recorded prior to treatment on the day of exposure and on Days 7 and 14.
- Necropsy of survivors performed: Yes, at the end of 14 days observation period the animals were killed by intravenous overdose of sodium pentobarbitone and subjected to complete external and internal examination for macroscopic abnormalities. The respiratory tract was examined macroscopically for signs of irritancy or local toxicity. - Statistics:
- None
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 1.41 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: no mortality was observed
- Mortality:
- No mortality was observed throughout the study period
- Clinical signs:
- other: - Signs of hunched posture, pilo-erection and red/brown staining around the snout and/or eyes are commonly seen in animals for short periods on removal from the chamber following 4-hour inhalation studies. Wet fur is commonly recorded both during and for
- Body weight:
- - Normal bodyweight gain was observed during the study.
- Several females showed reduction in body weight gain or a slight body weight loss during Week 1 and/or 2 but such variations are not uncommon in female rats of this strain and age are considered not to be significant. - Gross pathology:
- No macroscopic abnormalities were detected at necropsy.
- Other findings:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The combined inhalational LC50 was greater than 1.41 mg/L (mean maximum attainable atmosphere concentration). Under the test conditions, test item should not be classified according to the criteria of the Annex VI of the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).
- Executive summary:
In an acute inhalational toxicity study performed in accordance with GLP and OECD guideline 403, groups (5/sex) of Sprague Dawley Crl:CD® (SD) IGS BR rats were exposed to a dust atmosphere of Biosol at the mean maximum attainable atmosphere concentration of 1.41 mg/L air (nominal concentration: 77.0 mg/L) for 4 hours. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and necropsy was performed in all animals for macroscopical examination.
Common abnormalities noted during the study included increased respiratory rate, hunched posture and pilo-erection and there were isolated instance of red/brown staining to the eyes and/or snout. All animals recovered quickly to appear normal from Day 1 or 2 post-exposure. Normal bodyweight gain was observed during the study. Several females showed reduction in body weight gain or a slight body weight loss during Week 1 and/or 2 but such variations are not uncommon in female rats of this strain and age are considered not to be significant. No macroscopic abnormalities were detected at necropsy.
The combined inhalational LC50 was greater than 1.41 mg/L (mean maximum attainable atmosphere concentration).
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