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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

Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 478 (Genetic Toxicology: Rodent Dominant Lethal Test)
- Principles of method if other than guideline:
- The objective of this dominant lethal assay in mice was to determine the level of fetal death in untreated females following mating to males acutely treated with p-cresol. All stages of male germ cell development were evaluated (six mating periods).
- GLP compliance:
- yes
- Type of assay:
- rodent dominant lethal assay
Test material
- Reference substance name:
- p-cresol
- EC Number:
- 203-398-6
- EC Name:
- p-cresol
- Cas Number:
- 106-44-5
- Molecular formula:
- C7H8O
- IUPAC Name:
- p-cresol
- Details on test material:
- Test substance: p-cresol, 99.8% pure
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: males: 9.5 weeks
- Weight at study initiation: 26.7 - 36.7 g
- Assigned to test groups randomly: [no/yes, under following basis: ]
- Fasting period before study:
- Housing: males individually and females in groups
- Diet ad libitum
- Water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25
- Humidity (%): 50
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
all dosing solutions were prepared immediately prior to dosing
- Duration of treatment / exposure:
- Single dose
- Frequency of treatment:
- once
- Post exposure period:
- 6 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 275, 550 (650) mg/kg bw diluted in corn oil
Basis:
actual ingested
- No. of animals per sex per dose:
- 25 males/group were treated; 50 females /group
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- triethylenemelamine
- Route of administration: i.p.
- Doses / concentrations: 0.3 mg/kg
Examinations
- Tissues and cell types examined:
- All females were examined for the number of live and dead implants within the uterine horn and whether the dead implants had occurred early or late in gestation. Live fetuses were identified as those which appeared to have a functional circulatory capacity
- Evaluation criteria:
- statistically sognificant dose-related increase in the number of dominant lethals is considered as mutagenic in this testsystem.
- Statistics:
- Chi-square test, ANOVA, Dunnett's one-tailed t-test
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- see section " remarks on results"
Any other information on results incl. tables
650 mg/kg bw: 10/25 males within the first week; as signs of toxicity mice exhibited rapid breathing, several became languid with mild clonic convulsions and squinted eyes and were prostrate and had scruffy coats; 550 mg/kg bw: 6/25 males died during the test
body weight:
No significant reduction in body weight were observed in any of the males in any of the dose groups. The statistical evaluation of the parameters indicated that no significant effects of p-cresol were induced at any dose levels.
The treatment had no adverse effects with respect to number of early and late resorptions, and live implants, indicating that the test compound did not induce dominant lethal mutations in male germ cells of mice under the conditions of this assay.
The concurrent positive control substance TEM induced a significant increase in :
the number of dead implantations, in the portion of females with either one or more dead implantations, the frequency of dead implants relative to the total number of implants in each female during mating weeks 1 through 3 TEM induced a significant reduction in total implants relative to the vehicle control group.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
- Executive summary:
p-Cresol did not induce dominant lethal mutations in male germ cells of mice under the conditions of this assay when tested according to OECD TG 478 (Rodent Dominant Lethal Assay).
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