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EC number: 203-266-8 | CAS number: 105-06-6
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Subacute and Subchronic Oral Toxicity of p-Chlorotoluene in the Rat
- Author:
- JAMES B. TERRILL, MERREL ROBINSON, GARY W. WOLFE. And LEONARD H. BILLUPS
- Year:
- 1 990
- Bibliographic source:
- Journal Of The American College Of Toxicology, Volume 9, Number 5, Pg 487-495, 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- 14 days repeated dose oral toxicity study was performed to evaluate the toxic nature of the test compound p-Chlorotoluene
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- p-Chlorotoluene
- IUPAC Name:
- p-Chlorotoluene
- Reference substance name:
- 4-chlorotoluene
- EC Number:
- 203-397-0
- EC Name:
- 4-chlorotoluene
- Cas Number:
- 106-43-4
- Molecular formula:
- C7H7Cl
- IUPAC Name:
- 1-chloro-4-methylbenzene
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material: p-Chlorotoluene- Molecular formula: C7H7Cl- Molecular weight : 126.585 g/mol- Substance type: Organic- Physical state: Clear, colorless liquid- Impurities (identity and concentrations): > 98% pure
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley-derived (Crl:CD@ BR)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Charles River Laboratories, Inc. (Raleigh, NC)- Age at study initiation: 46 days- Weight at study initiation: 227.3-276.1 g males, 153.2-195.8 g females- Fasting period before study: No data- Housing: The rats were housed in stainless-steel wire-bottomed suspended cages, color-coded for dosage level. The rats within any treatment level were caged vertically to minimize light, temperature, and airflow differences between exposure groups- Diet (e.g. ad libitum): Purina Rodent Chow No. 5002 (Ralston Purina Co., St. Louis, MO) ad libitum- Water (e.g. ad libitum): Tap water ad libitum- Acclimation period: 2 weeksENVIRONMENTAL CONDITIONS- Temperature (°C): 22-24°C- Humidity (%):40-60%- Air changes (per hr): No data- Photoperiod (hrs dark / hrs light): 12-h light-dark cycleIN-LIFE DATES: From: To: No data
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: Corn oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: The chemical was dissolved in corn oil at dose levels of 0, 200, 600 or 1800 mg/Kg/dayDIET PREPARATION- Rate of preparation of diet (frequency): No data- Mixing appropriate amounts with (Type of food): No data- Storage temperature of food: No dataVEHICLE- Justification for use and choice of vehicle (if other than water): Corn oil- Concentration in vehicle: 0, 200, 600 or 1800 mg/Kg/day- Amount of vehicle (if gavage): No data- Lot/batch no. (if required): No data- Purity: No data
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The purity was determined to be greater than 98% by gas chromatographic-mass spectral analysis (GC-MS
- Duration of treatment / exposure:
- 14 days
- Frequency of treatment:
- 7 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:0, 200, 600 or 1800 mg/Kg/dayBasis:
- No. of animals per sex per dose:
- Total: 800 mg/Kg/day: 10 males and 10 females200 mg/Kg/day: 10 males and 10 females600 mg/Kg/day: 10 males and 10 females1800 mg/Kg/day: 10 males and 10 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The high-dose level was chosen as one half of the reported LD50 and was expected to produce a toxic effect. The lowest dose was selected to be a no-effect level.- Rationale for animal assignment (if not random): Yes, randomized- Rationale for selecting satellite groups: No data- Post-exposure recovery period in satellite groups: No data- Section schedule rationale (if not random): No data
- Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes- Time schedule: Twice daily for Mortality, Morbidity. All rats were observed daily by careful cageside observation. Physicalexaminations were performed weekly- Cage side observations checked in table [No.?] were included. Mortality, Morbidity, overt signs of toxicity, DETAILED CLINICAL OBSERVATIONS: Yes, any abnormalities in housing. food, water, or clinical signs involving general appearance, behavior, excretion, respiration, skin, pelage. or eyes were recorded- Time schedule: No dataBODY WEIGHT: Yes- Time schedule for examinations: Individual body weights were measured prior to randomization, at initiation of dosing, and weekly thereafteFOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes, Food consumption was measured weekly- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No dataFOOD EFFICIENCY:- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No dataWATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data- Time schedule for examinations: No dataOPHTHALMOSCOPIC EXAMINATION: No data- Time schedule for examinations: No data- Dose groups that were examined: No dataHAEMATOLOGY: Yes- Time schedule for collection of blood: Prior to necropsy- Anaesthetic used for blood collection: Yes, ketamine- Animals fasted: Yes, overnight fasting- How many animals: All animals- Parameters checked in table [No.?] were examined. leukocyte, erythrocyte. hematocrit, and hemoglobin tests; leukocyte differentials and cell morphologyCLINICAL CHEMISTRY: Yes- Time schedule for collection of blood: Prior to necropsy- Animals fasted: Yes, overnight fasting- How many animals: All animals- Parameters checked in table [No.?] were examined. sodium, potassium, total protein, albumin, calcium, total bilirubin, creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), lactate dehydrogenase (LDH). and blood urea nitrogenURINALYSIS: Yes- Time schedule for collection of urine: Prior to necropsy- Metabolism cages used for collection of urine: No data- Animals fasted: No data- Parameters checked in table [No.?] were examined. pH, glucose, protein, bilirubin, occult blood. and urobilinogenNEUROBEHAVIOURAL EXAMINATION: Y No data- Time schedule for examinations: No data- Dose groups that were examined: No data- Battery of functions tested: sensory activity / grip strength / motor activity / other: No dataOTHER: No data
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, Animals were weighed. anesthetized with sodium pentobarbital, exsanguinated and necropsied. Organ weights were obtained for the following organs: liver, kidneys. spleen, adrenal glands. thymus, brain, heart, lung, testes with epididymis and ovaries. Organ-to-terminal body weight ratios were calculated.Additionally, necropsies were performed on all animals that died prior to the terminal sacrifice. A full tissue list was preserved from each animal.HISTOPATHOLOGY: Yes, The following tissues were evaluated from all animals in the 600 mgikg per day animals in the 14-day study as well as from five randomly selected animals per gender in corn oil control animals: adrenals, thyroid, esophagus, trachea, larynx, heart, spleen, liver, kidney, stomach, duodenum, jejunum, colon, pancreas, and gross lesions.
- Other examinations:
- No data
- Statistics:
- All appropriate data were subjected to Levene's test of homogeneity of variance and an analysis of variance. Non-homogeneous data were subjected to a series of transformations in order to achieve homogeneity . When the series of transformations were ineffective in achieving homogeneity, analysis of ranked data were performed. Group comparisons were evaluated using Dunnett's t-test at the 5.0% two-tailed probability Ievel.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Animals at 1800 mg/Kg bw frequently exhibited prostration, salivation, and tremors following dosing
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- At 1800 mg/Kg bw- Males- 8/10 Females- 8/10
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- A statistically significant decrease in body weight was exhibited by both males and females in the high-dose group (1800 mg/kg/day) at Weeks 1 and 2. Body weight gain (Weeks 0-2) for these animals was also significantly decreased. Mid-dose males (600 mg/kp/day) exhibited a significant decrease in body weight gain (Weeks 0-2).
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Total food consumption (Week 1) was significantly decreased for males in the mid- and high-dose groups.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No treatment related effects were noted
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Organ weight comparisons between mid-dose animals with control animals revealed a number of differences: all were considered related to a lower terminal body weight or considered to be a general indication of stress.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No treatment related gross pathology effects were noted
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- No treatment-related lesions were observed
- Other effects:
- not specified
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 600 other: mg/Kg/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No treatment related effects were noted
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The No observed adverse effect level (NOAEL) for the test chemical is considered to be 600 mg/Kg/day when male and female Sprague-Dawley-derived (Crl:CD@ BR) rats were treated for 14 days.
- Executive summary:
14 days repeated dose oral toxicity study was performed to evaluate the toxic nature of the test compoundp-Chlorotoluene. Male and female Sprague Dawley rats were dosed daily at dose levels of 0, 200, 600 or 1800 mg/Kg/day for 14 days. The animals were observed for cage side observations, clinical signs, body weight and food consumtion, hematology, clinical pathology parameters and usinalysis following gross and histopathology. Treatment related severe effects were noted at 1800 mg/Kg/day. Based on the observations made, the No observed adverse effect level (NOAEL) for the test chemical is considered to be 600 mg/Kg/day when male and female Sprague-Dawley-derived (Crl:CD@ BR) rats were treated for 14 days.
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