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Diss Factsheets
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EC number: 201-793-8 | CAS number: 88-04-0
- 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
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Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: LSR Standard Operating Procedure QAU/020 and QAU/040
- Deviations:
- not applicable
- GLP compliance:
- no
- Test type:
- concentration x time method
- Limit test:
- yes
Test material
- Reference substance name:
- 4-chloro-3,5-xylenol
- EC Number:
- 201-793-8
- EC Name:
- 4-chloro-3,5-xylenol
- Cas Number:
- 88-04-0
- Molecular formula:
- C8H9ClO
- IUPAC Name:
- 4-chloro-3,5-dimethylphenol
- Test material form:
- solid: crystalline
- Details on test material:
- Sponsor's identification
Description
Batch number
Date received
Storage conditions
PCMX
cream coloured, crystalline solid
285/13847
27 September 2001
room temperature, in the dark
Constituent 1
- Specific details on test material used for the study:
- The test compound as received was micronised before use.
Test atmospheres were generated using a Wright dust feed mechanism (L, Adams Limited, London, England) mounted on the top of the chamber. Dry oil-free compressed air was passed through the apparatus at a pressure of 10 psi , givi ng an air-flow of ca. 18 L/min
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Young adult albino rats of the CD strain (remote Sprague-Dawley origin) , supplied by Charles River (U.K. ) Limited, were about 6 - 11 weeks old on arrival and were within the bodyweight range 180 - 198 g for males and 198 - 215 g for female rats. The animals had been bred under barriered conditions and travel led from the supplier to the animal-holding room in sealed boxes with filter protected airvents. The albino rat was selected for this study as the standard laboratory species for use in acute toxicity tests, The strain has been used for toxicological purposes since its establishment under S.P.F. conditions in 1955. There is extensive knowledge of the biology of the individual animal .
The animals were housed in high density polypropylene cages, measuring 56 x 38 x 18 cm, with stainless steel grid floors and tops (North Kent Plastics Limited), The grid floor ensured rapid removal of waste material to undertrays which were cleaned as necessary. In the preliminary study each cage contained two animals of the same sex. In the main study, a minimum floor area of 250 cm 2 per rat was provided by housing five animals, of the same sex and dosage group, in each cage. Mobile tubular steel racks each held up to 21 suspended cages.
Each room within the l imited-access building has been assigned to one species alone. Al l rooms were kept at slight positive pressure relative to the outside and each had its own filtered air supply giving approximately 17 complete air changes per hour without recirculation. The maximum and minimum temperatures of the previous 24-hour period and the relative humidity were recorded at the beginning of each working day, The target temperatures and humidity values for the animal room were 2 IC (acceptable limits 18 0 - and 55% R.H. (acceptable l imits 40% - 70% R.H. ) respectively.
Electric time-switches regulated a lighting cycle of 12 hours of artificial light per day. A stand-by generator was available to maintain the electricity supply in the event of a mains power failure. All personnel entering the building changed into clean protective clothing and wore an additional gown, alternative footwear, gloves and face mask to service animal -holding areas.
A commercially-available complete pelleted rodent diet (Spratt's Laboratory Diet No. 1 from K and K Greeff Ltd. , Croydon, London) was fed without restriction, except for the removal of food approximately 18 hours before the test substance was administered.
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- ca. 6.29 other: mg/L
- Geometric standard deviation (GSD):
- >= 2.8 - <= 3.1
- Remark on MMAD/GSD:
- See study
- Details on inhalation exposure:
- Particle size distribution
The particle size distribution was measured twice per hour during the exposure period.
The aerosol was characterised using a cascade impactor (Model MKIIa, from C. F, Casella and Company Limited, London) which was located into a vacant animal exposure. The particle size distribution (from which the median EAD was derived) was detemined using the ECD (Effective Cut-off Diameter) method of bulk estimation, the mass recovered at each stage being detemined by the weight gain of the sampling discs,
All weighing was perfomed using an electronic balance (Model 2006 MP6, Sartorius Instruments Limited, Surrey) and recorded to the nearest 0, 1 milligram.
A clean glass sampling disc was used as a check weight for each series of weighings. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Remarks on duration:
- A single four-hour period. Signs of reaction to treatment were recorded during a subsequent 14day period of observation, All animals were sacrificed on Day 15 and subjected to a detailed necropsy.
- Concentrations:
- The acute inhalation toxicity of 4-chl oro-3.5-xy1en01 , hereafter referred to as PCMX, was investigated i n a group of five male and five female rats exposed by snout only to the maximum practicable concentration of 6.29 mg/L of PCMX, for a single four-hour period. Signs of reaction to treatment were recorded during a subsequent 14day period of observation, All animals were sacrificed on Day 15 and subjected to a detailed necropsy.
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs,organ weights, body weight
Results and discussion
- Preliminary study:
- A dose range-finding test was performed using two males and two female rats.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- other: dose-range finding
- Effect level:
- 7.9 mg/L air
- Based on:
- test mat.
- Remarks on result:
- other: No observed deaths
- Mortality:
- 0
- Clinical signs:
- other: 0
- Body weight:
- n/a
- Gross pathology:
- 0
- Other findings:
- Because no death occurred as a result of treatment, the low toxicity of PCMX was demonstrated by administeri ng the maximum practicable air concentration to a single group of five males and five females.
Applicant's summary and conclusion
- Interpretation of results:
- other: Meets standards of the day, LSR SOP's
- Conclusions:
- Under the conditions of this study, the acute median lethal concentration for four hour exposure (LC four-hour) to PCMX was above 6.29 mg/ z
- Executive summary:
A total PCMX aerosol concentration of 6.29 mg/L was achieved as compared with a nominal value of 9.4 mg/L calculated from materials balance. Measurements of particle size indicated that cae 24% by weight of the suspended PCMX aerosol consisted of particles with equivalent aerodynamic diameters less than 5 um, which could be considered respirable to the rat.
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