Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-577-9 | CAS number: 108-39-4
- 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

Neurotoxicity
Administrative data
Description of key information
To examine probable neuro toxicity of m-cresol male and femaleCD rats received corn oil solutions of 0, 50, 150, 450 mg/kg bw/day by gavage once daily for 13 weeks. Dose related signs of toxicity and in high dosed rats neurobehavioural signs oftoxicity were reported.
A host of clinical observations indicative of neurotoxicity
(including hypoactivity, rapid labored respiration, excessive
salivation, and tremors) was reported at doses of 50 mg/kg/day or higher
for all three isomers. However, the results of a number of
neurobehavioral tests designed to assess demeanor and motor and reflex
activity (testing was done 6 times throughout the 13 weeks prior to
dosing) showed only sporadic differences with controls and/or
alterations were not dose-related. No brain weight changes or
histopathologic lesions in the brain or other nervous tissues were found
for any isomer. Convulsions were reported at 450 mg/kg/day or higher
(TRL 1986).
The NOAEL is 50 mg/kg bw (see TOXICOLOGICAL PROFILE FOR CRESOLS, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, Public Health Service Agency for Toxic Substances and Disease Registry).
Key value for chemical safety assessment
Effect on neurotoxicity: via oral route
Link to relevant study records
- Endpoint:
- neurotoxicity: oral
- Remarks:
- 13 week neurotoxicity study
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: only study summary is available: limited documentation
- Principles of method if other than guideline:
- 10 male and 10 female CD rats/treatment group received corn oil solutions of 50, 175, 450 or 600 mg/kg bw/day by gavage once daily for 13 weeks. 20 male and 20 female CD rats received corn oil alone to serve as control. Rats were observed for body weight gain, food consumption, clinical signs and signs of neurobehavioral toxicity.
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- other: CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no further data
- Route of administration:
- oral: gavage
- Vehicle:
- other: corn oil
- Details on exposure:
- no further data
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- once daily, 13 weeks
- Remarks:
- Doses / Concentrations:
0, 50, 150, or 450 mg/kg bw dissolved in corn oil
Basis: - No. of animals per sex per dose:
- 10 animals /sex/dose, 20 animals per sex/dose served as controls
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Type: other: subchronic study
Observation period: 13 weeks - Observations and clinical examinations performed and frequency:
- only summary available
- Specific biochemical examinations:
- only summary available, see section" any other information on malterials and methods"
- Neurobehavioural examinations performed and frequency:
- only summary available, see section" any other information on malterials and methods"
- Sacrifice and (histo)pathology:
- only summary available, see section" any other information on malterials and methods"
- Other examinations:
- only summary available, see section" any other information on malterials and methods"
- Positive control:
- only summary available, see section" any other information on malterials and methods"
- Statistics:
- only summary available, see section" any other information on malterials and methods"
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Behaviour (functional findings):
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Neuropathological findings:
- not specified
- Other effects:
- not examined
- Description (incidence and severity):
- Migrated information from 'Further observations for developmental neurotoxicity study'
Details on results (for developmental neurotoxicity):see section "Remarks on results";: this is no developmental neurotoxicity study (migrated information) - Details on results:
- see section " Remarks on results"
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 50 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: dose related clinicl signs of toxicity, but only study abstract is available
- Remarks on result:
- other:
- Executive summary:
According to an available stuy report summary:
CD rats/sex and treatment group received corn oil solutions of 0, 50, 150, 450 mg/kg bw/day by gavage once daily for 13 weeks to examine neurotoxicity of m-cresol resulting in dose related clinicl signs of toxicity and neurobehavioral signs of toxicity in high dosed animals. The NOAEL is 50 mg/kg bw/day.
Reference
Mortality: 450 mg/kg bw: 1 female versus 1 female of controls gross and histopathological examination of the treated females revealed as cause of death: aspiration or inhalation of the test material or pulmonary edema.
Mean body weight: no difference to the controls.
Food consumption 450 mg/kg bw/day, males and females: significantly less than control during the initial portion of the study.
Clinical signs: from 50 mg/kg bw/day onwards: dose-related in incidence and included salivation, myotonus, tremors, urine wet abdomen, hypoactivity, rapid respiration, myoclonus, low body posture and labored respiration.
Neurobehavioral toxicity: 450 mg-group, males and females: initial part of the study: incidence of palpebral closure, rales, labored respiration at study termination, females: significantly increased urination Other differences from controls with regared to behavioural tests were evaluated as sporadic in nature by the authors (no further details given) Necropsy: brain weights of treated animals comparable to controls; gross and microscopic examination of tissues revealed no lesions which were attributable to treatment.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 50 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- only abstact available
Effect on neurotoxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Effect on neurotoxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
To examine probable neuro toxicity of m-cresol male and femaleCD rats received corn oil solutions of 0, 50, 150, 450 mg/kg bw/day by gavage once daily for 13 weeks. Dose related signs of toxicity and in high dosed rats neurobehavioural signs oftoxicity were reported. The NOAEL is 50 mg/kg bw/day (abstract only, TRL 1986).
A host of clinical observations indicative of neurotoxicity (including hypoactivity, rapid labored respiration, excessive salivation, and tremors) was reported at doses of 50 mg/kg/day or higher for all three isomers. However, the results of a number of neurobehavioral tests designed to assess demeanor and motor and reflex activity (testing was done 6 times throughout the 13 weeks prior to dosing) showed only sporadic differences with controls and/or alterations were not dose-related. No brain weight changes or histopathologic lesions in the brain or other nervous tissues were found for any isomer. Convulsions were reported at 450 mg/kg/day or higher (TRL 1986).
Justification for selection of effect on neurotoxicity via oral
route endpoint:
only study available
Justification for classification or non-classification
No classification is required.
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.
