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EC number: 202-423-8 | CAS number: 95-48-7
- 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
Endpoint summary
Administrative data
Description of key information
There is no study according to the current guideline but the given
information is sufficient to evaluate this endpoint.
The oral LD50 of undiluted o-cresol in rats is 121 mg/kg bw and the
dermal LD50 for rabbits is 1380 mg/kg bw (Ind Bio-test Lab Inc 1969).
The data base on acute inhalation toxicity of o-cresol 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: individual animal data not given
- Principles of method if other than guideline:
- 5 male rats/dose, observed for symptoms and mortality up to 10-14 days, 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:
- other: undiluted
- Details on oral exposure:
- no further data
- Doses:
- 68, 100, 147, 215 mg/kg bw
- No. of animals per sex per dose:
- 5 male rats/dose
- Control animals:
- no
- Details on study design:
- no further details
- Statistics:
- yes, but method not mentioned
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 121 mg/kg bw
- Remarks on result:
- other: signs of intoxication included hypoactivity, tremor, convulsions, salivation, dyspnea, prostration within 4 hours post dosing
- Mortality:
- 68 mg/kg bw: no deaths but signs of intoxication; recovery within 2 days
100 mg/kg bw: mortality: 2/5; survivors recovered within 4 days
147 mg/kg bw: mortality: 3/5; surviors recovered within 6 days
215 mg/kg bw: mortality: 5/5 - Clinical signs:
- other: All animals showed signs of intoxication including hypoactivity, tremor, convulsions, salivation, dyspnea, prostration within 4 hours post dosing
- Gross pathology:
- At autopsy , survivors showed no significant findings, decedents showed hemorrhage of gastrointestinal tract, hyperemia of liver , kidneys and lungs
- Other findings:
- no further data
- Interpretation of results:
- Category 3 based on GHS criteria
- Executive summary:
To determine LD50 -value 5 male rats/dose received single oral doses of 68, 100, 147, 215 mg/kg bw by gavage and were observed for symptoms and mortality for up to 10 -14 days. Suvivors and decedents were examined afterwards by gross autopsy.
LD50 was determined 121 mg/kg bw (Industrial Bio-test Laboratories 1969).
Reference
All animals showed signs of intoxication including hypoactivity, tremor,
convulsion, salivation, dyspnea, prostration within 4 hours post dosing
and from 100 mg onwards animals died.
Mortality occurred within 4 hours post dosing;
68 mg/kg bw: no deaths but signs of intoxication; recovery within 2 days
100 mg/kg bw: mortality: 2/5; survivors recovered within 4 days
147 mg/kg bw: mortality: 3/5; surviors recovered within 6 days
215 mg/kg bw: mortality: 5/5
At autopsy, survivors showed no significant findings, decedents showed
hemorrhage of gastrointestinal tract, hyperemia of liver, kidney and
lungs.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 121 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: individual animal not shown
- Principles of method if other than guideline:
- 5 rabbits/dose, exposure period not given, observation up to 14 days, 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
- Type of coverage:
- not specified
- Vehicle:
- other: undiluted
- Details on dermal exposure:
- no further data
- Duration of exposure:
- no data
- Doses:
- 681, 1000, 1470, 2150 mg/kg bw.
- No. of animals per sex per dose:
- 5 rabbits/dose.
- Control animals:
- not specified
- Details on study design:
- no further data
- Statistics:
- yes, but method not mentioned
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 1 380 mg/kg bw
- 95% CL:
- >= 841 - <= 2 260
- Remarks on result:
- other: clinical signs included hypoactivity salivation, tremors ; dermal irritation: severe erythema
- Mortality:
- 681 mg/kg bw: 1/5
1000 mg/kg bw: 2/5
1470 mg/kg bw: 2/5
2150 mg/kg bw: 4/5 - Clinical signs:
- other: Hypoactivity salivation, tremors; dermal irritation: severe erythema.
- Gross pathology:
- Gross autopsy: survivors: no significant findings; decedents: hyperemia of the liver and lungs.
- Other findings:
- no further details
- Interpretation of results:
- Category 4 based on GHS criteria
- Executive summary:
Single dermal application of undiluted o-cresol (681 -2150 mg/kg bw) to the skin of rabbits resulted in an LD50 value of 1380 mg/kg bw. Clinical signs displayed by the animals included hypoactivity, tremors, convulsion, salivation, dyspnea, prostration and additionally severe erythema.(Industrial Biotest Laboratories 1969).
Reference
Signs of intoxication: Hypoactivity, salivation, tremor, severe erythema.
681 mg/kg bw: 1/5 rabbit died between day 8 and day 14, but showed no
signs of intoxication.
1000 mg/kg bw: clinical signs developed between 4-12 hours and 2/5
rabbits died within the first 2 days.
1470 mg/kg bw: clinical clinical signs developed between 4-12 hours, 1/5
rabbit died on day 2 and 1/5 between day 8 and day 14.
2150 mg/kg bw: clinical signs developed between 0-4 hours, death of 4/5
rabbits occurred within 4 days.
Gross autopsy revealed in survivors no significant findings; decedents
showed hyperemia of the liver and lungs.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 380 mg/kg bw
Additional information
There is no study according to the current guideline but the given information is sufficient to evaluate this endpoint.
ORAL APPLICATION
To determine LD50 value 5 male rats/dose received single oral doses of 68, 100, 147, 215 mg/kg bw by gavage and were observed for symptoms and mortality for up to 10 -14 days. Suvivors and decedents were examined afterwards by gross autopsy: LD50 was determined 121 mg/kg bw (Industrial Bio-test Laboratories 1969).
DERMAL APPLICATION
Single dermal application of undiluted o-cresol (681 -2150 mg/kg bw) to the skin of rabbits resulted in an LD50 value of 1380 mg/kg bw . Clinical signs displayed by the animals included hypoactivity, tremor, convulsion, salivation, dyspnea, prostration and additionally severe erythema.(Industrial Biotest Laboratories 1969).
INHALATION EXPOSURE
No rat died during the 1 hour exposure against 1.22 mg/l. (not further specified, Ind Bio-test Lab Inc 1969). Following a 6 hour exposure of rats against o-cresol mist no animal died upto 20 mg/l. (Conoco Inc 1982). Clinical signs displayed by animals included hypoactivity, tremor, convulsion, salivation, dyspnea , prostration .In an early, not adequately documented publication, exposure of mice against o-cresol (mixture of vapour and aerosol) resulted in a LC50 value 0.178 mg/l but neither exposure time nor any other experimental details are given. Thus, the reliability of this information is not assignable (Uzhdanini 1972, 1974).
Overall, the data base on acute inhalation toxicity of o-cresol is very limited and does not allow final conclusion. Nevertheless further testing is not required because o-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.
Justification for classification or non-classification
Under R67/548/EEC (19.ATP) m-and p-cresol as well as o-cresol ared classified as toxic in contact with skin and if swallowed R24/25
Referring to the acute inhalation exposure the given information is insufficient to evaluate the need for classification because important exeperimental datails are not given. Therefore no classification is required.
According to CLP classification criteria (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.
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