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Diss Factsheets
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EC number: 203-398-6 | CAS number: 106-44-5
- 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://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Following single oral doses to rats the LD50 was determined 207 mg/kg bw. The LD50(dermal, rabbit) was calculated to be 301 mg/kg bw.
The data base on acute inhaltion toxicity of p-cresol is very limited and does not allow a final conclusion.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No information about strain used, GLP
- Principles of method if other than guideline:
- 5 rats/dose group, observed for symptoms for up to 14 d, afterwards gross autopsy.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- no further data
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- no flurther data
- Doses:
- 100, 147, 215, 316 mg/kg bw
- No. of animals per sex per dose:
- 5 male rat/dose
- Control animals:
- no
- Details on study design:
- no further details
- Statistics:
- yes, but method not mentioned
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 207 mg/kg bw
- 95% CL:
- >= 172 - <= 250
- Remarks on result:
- other: hypoactivity, tremor, lacrimation, dyspnea, hemorrhagic rhinitis, conculsion, prostration
- Mortality:
- Mortality occurred within 4 hours post dosing
100 mg/kg bw: 0/5; 147 mg/kg bw: 0/5; 215 mg/kg bw: 3/5; 316 mg/kg bw: 5/5. - Clinical signs:
- other: Onset in all animals within the first 4 hours post dosing: hypoactivity, tremors, lacrimation, dyspnea, hemorrhagic rhinitis, convulsions, prostration, recovery occurred in all survivors.
- Gross pathology:
- Necropsy of the rats that died revealed gastrointestinal inflammation and haemorrhage and hyperaemia of the lungs, liver and kidney.
Survivors showed only gastrointestinal tract inflammation.
- Other findings:
- no further data
- Executive summary:
Following single oral doses to rats the LD50 was determined 207 mg/kg bw. The observed signs of intoxication included hypoactivity, tremors, lacrimation, dyspnea, hemorrhagic rhinitis, convulsions and prostration.
Reference
Doses and mortality:
100 mg/kg bw: 0/5; 147 mg/kg bw: 0/5; 215 mg/kg bw: 3/5; 316 mg/kg bw: 5/5
Signs of intoxication: hypoactivity, tremors, lacrimation, dyspnea, hemorrhagic rhinitis, convulsions, prostration, death.
Necropsy of the rats that died revealed gastrointestinal inflammation and haemorrhage and hyperaemia of the lungs, liver and kidney.
Survivors showed only gastrointestinal tract inflammation.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 207 mg/kg bw
- Quality of whole database:
- The materials/methods and results are described sufficient for evaluation.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: no information about strain used and no information on GLP.
- Principles of method if other than guideline:
- 5 rabbits/dose, 4 doses, exposure time not mentioned, up to 14 d observation time, gross autopsy.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no further data
- Vehicle:
- other: none
- Details on dermal exposure:
- no further data
- Duration of exposure:
- no data
- Doses:
- 215, 316, 464, 681 mg/kg bw
- No. of animals per sex per dose:
- 5 rabbits per dose
- Control animals:
- no
- Details on study design:
- no further data
- Statistics:
- yes, but method not mentioned
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- ca. 301 mg/kg bw
- 95% CL:
- >= 213 - <= 426
- Remarks on result:
- other: tremor, salivation, sedation , severe subdermal hemorrhaging, severe erythema
- Mortality:
- : 215 mg/kg bw: 1/5; 316 mg/kg bw: 3/5; 464 mg/Kg bw: 4/5; 681 mg/kg bw: 5/5
- Clinical signs:
- other: signs of intoxication from 4-12 hrs post appl.: tremor, salivation sedation , recovery occurred within 3 days post application
- Gross pathology:
- gross autopsy: survivors: no significant findings; decedents: inflammation of kidneys
- Other findings:
- dermal irritation: severe subdermal hemorrhaging, severe erythema
- Executive summary:
To determine LD-50 value, rabbits received dermal application of 215 -681 mg/kg bw undiluted p-cresol and were observed for clinical signs of toxicity and mortality for up to 14 days: LD50 was determined 301 mg/kg bw. As signs of intoxication tremor, salivation, sedation was noted ; the treated skin showed severe erythema and severe subdermal hemorrhaging.
Reference
Doses and mortality:
215 mg/kg bw: 1/5; 316 mg/kg bw: 3/5; 464 mg/Kg bw: 4/5; 681 mg/kg bw: 5/5 signs of intoxication from 4-12 hrs post appl.: tremor, salivation sedation, death dermal irritation: severe subdermal hemorrhaging, severe erythema
gross autopsy: survivors: no significant findings;
decedents: inflammation of kidneys
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 301 mg/kg bw
- Quality of whole database:
- The materials/methods and results are described sufficient for evaluation.
Additional information
ORAL TOXICITY
There is no acute study according to the current OECD test guidelines, but the given information is sufficient to evaluate this endpoint
Following single oral doses to rats the LD50 was determined 207 mg/kg bw. The observed signs of intoxication included hypoactivity, tremors, lacrimation, dyspnea, hemorrhagic rhinitis, convulsions and prostration (Ind Bio-test Lab Inc 1969).INHALATION TOXICITY
Following exposure of rats against 710 mg/m³ p-cresol for 1 hour, no rat died and no clinical findings were reported (Ind Bio-test Lab Inc 1969). In Pereima 1975 (cited in WHO1995) the LC50 in rats is reported to be 29 mg/m³ for p-cresol, but exposure time and other relevant data were not available. Clinical signs of toxicity included irritation of mucous membranes, neuromuscular excitation and convulsions; hematuria is reported at very high concentrations.
Overall, the data base on acute inhalation toxicity of p-cresol is very limited and does not allow final conclusion. Nevertheless further testing is not required because p-cresol is evaluated as corrosive and is classified /labelled accordingly. This is in accordance with the specific rules (Column 2) of ANNEX VIII No. 8.5 of Regulation (EC) No. 1907/2006 (REACH): acute toxicity studies do not generally need to be conducted if the substance is classified as corrosive to the skin.
DERMAL TOXICITY
There is no acute study according to the current OECD test guidelines, but the given information is sufficient to evaluate this endpoint
To determine LD50 (dermal) value, rabbits received dermal application of 215 -681 mg/kg bw undiluted p-cresol and were observed for clinical signs of toxicity and mortality for up to 14 days: LD50 was calculated to be 301 mg/kg bw. As signs of intoxication tremor, salivation, sedation was noted ; the treated skin showed severe erythema and severe subdermal hemorrhaging (Ind. Bio-test Lab Inc 1969).Justification for selection of acute toxicity – oral endpoint
The most reliable study was used as key study and for classification.
Justification for selection of acute toxicity – dermal endpoint
The most reliable study was used as key study and for classification.
Justification for classification or non-classification
According to Regulation (EC) No. 1272/2008 the substance is allocated to Category 3 for acute toxicity by oral and dermal route; Hazard Communication H301 and H311.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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