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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
![](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 treatment of rats LD50 is 242 mg/kg bw. Follwing
dermal application to rabbits the LD50 was 2050 mg/kg bw. Clinical signs
included hypoactivity, salivation, tremors and convulsions. The skin of
dermal treated rabbits show additionally severe erythema and burns.
The databases on acute inhalation toxicity of m-cresol in animals is
very limited and does not allow 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 on strain used , no information on statistical evaluation given
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Method: single application by gavage, 5 rats/dose group, 4 doses, undiluted liquid, time of recovery: up to 14 days, observations for signs of toxicity, necropsy at the end of the observation time.
- GLP compliance:
- not specified
- 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 data
- Route of administration:
- oral: gavage
- Vehicle:
- other: none
- Details on oral exposure:
- no further data
- Doses:
- 147, 215, 316, 464 mg/kg bw.
- No. of animals per sex per dose:
- 5 males/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily; weighing at the beginning and at the end
:
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross autopsy of survivors and decedents - Statistics:
- yes, method not described
- Preliminary study:
- no data
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 242 mg/kg bw
- 95% CL:
- >= 190 - <= 308
- Remarks on result:
- other: Clinical signs included hypoactivity, salivation, tremors and convulsions
- Mortality:
- see section"remarks on results including tables and figures".
- Clinical signs:
- other: onset: 0-4 hours: hypoactivity, tremor, convulsions salivation, prostration death (see section"remarks on results including tables and figures").
- Gross pathology:
- survivors: no significant findings
decedents: inflammation of the gastrointesinal tract, hyperemia of lungs, liver, kidneys
see section"remarks on results including tables and figures" - Other findings:
- no further data
- Interpretation of results:
- Category 3 based on GHS criteria
- Executive summary:
Single oral application of undiluted testsubstance by gavage to 5 rats/dose group and an observation time up to 14 days resulted in an LD50 value of 242 mg/kg bw.
Reference
dosage onset of sympt. mortality mortality
mg/kg bw 0-4 hrs 0-4hrs day3 day6 day7 cumulat.
147 S 0/5
215 S 1/5 1/5 2/5
316 S 3/5 1/5 4/5
464 S 4/5 1/5 5/5
S=signs of intoxication: Hypoactivity, H tremors, convulsions,
salivation, prostration
survivors: recovery within observation time, gross necropsy: no
significant findings
decedents, gross necropsy: inflammation of the gastrointestinal tract,
hyperemia of lungs, liver and kidneys.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 242 mg/kg bw
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, statistical evaluation not given
- Principles of method if other than guideline:
- 5 rabbits/dose, 4 doses, exposure time not mentioned, up to 14 days post exposure observation time.
- GLP compliance:
- not specified
- 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:
- TEST ANIMALS
- Weight at study initiation: 2.29 -2.67 kg - Type of coverage:
- not specified
- Vehicle:
- other: none
- Details on dermal exposure:
- no further data
- Duration of exposure:
- no data
- Doses:
- 1000, 1470, 2150, 3160 mg/kg bw.
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors and decedents performed: yes
- Other examinations performed: clinical signs, - Statistics:
- yes, method not given.
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 2 050 mg/kg bw
- 95% CL:
- >= 1 590 - <= 2 650
- Remarks on result:
- other: Clinical signs included hypoactivity, salivation, tremors and convulsions; the treated skin showed severe erythema and burns.
- Mortality:
- see section "remarks on results"
- Clinical signs:
- other: see section " remarks on results including tables and figures"
- Gross pathology:
- see sedtion " remarks on results including tables and figures"
- Other findings:
- no data
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Dermal application of testsubstance to the skin of rabbits and an exposure observation time for 14 days yielded a LD50 of 2050 mg/kg bw and severe irritational effects.
Reference
Dosage onset of symp. mortality mortality
mg/kg 4-12 hrs 12-24 hrs day3 cumulative
100 0 0/5
147 0 0/5
215 0 S 4/5 4/5
316 0 S 4/5 4/5
S = signs of intoxication from 4 hrs up to 12 hrs p.a.: lacrimation,
salivation,
hypersensitivity, convulsion, hypoactivity:
dermal
irritation: severely burned, severe edema
gross necropsy-survivors: no significant findings
gross necropsy-decedents: hyperemia of lungs and kidneys
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 050 mg/kg bw
Additional information
There is no study according to the current OECD test guideline, but the given information is sufficient to evaluate this endpoint.
ORAL APPLICATION
Single oral application of undiluted test substance by < gavage to 5 rats/dose group and an observation time up to 14 days resulted in an LD50 value of 242 mg/kg bw. Clinical signs included hypoactivity, salivation, tremors and convulsions (Ind Bio-test Lab Inc 1969).
DERMAL APPLICATION
Following dermal application to rabbits of undiluted test substance and an observation time for 14 days the LD50 was 2050 mg/kg bw (Industr. Bio-test Lab Inc 1969). Clinical signs included hypoactivity, salivation, tremors and convulsions; the treated skin showed severe erythema and burns.
INHALATION EXPOSURE
No rat died during the 1 hour exposure against 710 mg/m³ (not further specified, Industr. Bio-tes Lab 1969). In an 8-hour inhalation study with saturated vapor, no ratl died and no signs of intoxication were observed (Mellon Inst Ind Res 1949). In Pereima 1975 cited in WHO 1995 the LC50 in rats was reported to be 58 mg/m³ but exposure period and other relevant data were not available.Clinical signs of intoxication included irritation of mucous membranes, neuromuscular excitation and convulsions.
Overall, the databases on acute inhalation toxicity of m-cresol is very limited and does not allow final conclusion. Nevertheless, further testing is not required because m-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), a study does not generally need to be conducted if the substance is classified as corrosive to the skin.
Justification for classification or non-classification
Based on the cited acute data with oral and dermal exposure a change in classification and labelling could be considered, but the data base is very limited. Therefore the present classification is accepted. Referring to acute inhalation exposure the given information is insufficient to evalutate the need for classification because important experimental details are not given. Therefore a classification is not required.
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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