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EC number: 203-397-0 | CAS number: 106-43-4
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well documented and scientifically acceptable
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Subacute and subchronic oral toxicity of p-chlorotoluene in rats
- Author:
- Terrill JB, Robinson M, Wolfe GW, Billups LH
- Year:
- 1 990
- Bibliographic source:
- J Am Coll Toxicol 9, 487-495, also in EPA-PB91-233379.
- Reference Type:
- publication
- Title:
- Subacute and subchronic oral toxicity of p-chlorotoluene in the rat
- Author:
- Terrill JB, Robinson M, Wolfe GW, Billups LH
- Year:
- 1 990
- Bibliographic source:
- Toxicologist 10(1), 61 (abstr.)
Materials and methods
- Principles of method if other than guideline:
- p-Chlorotoluene was administered by gavage for 14 and 90 days to Sprague-Dawley-derived rats at dose levels of 200, 600 and 1800 mg/kg/day and 50, 200 and 800 mg/kg/day, respectively.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 4-chlorotoluene
- EC Number:
- 203-397-0
- EC Name:
- 4-chlorotoluene
- Cas Number:
- 106-43-4
- Molecular formula:
- C7H7Cl
- IUPAC Name:
- 4-chlorotoluene
- Details on test material:
- the purity was determined to be greater than 98 %; 1-Chloro(4-chloromethyl)benzene at 0.5 % was identified as the only impurity
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 d
- Frequency of treatment:
- daily, 7 d/w
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 200 or 800 mg/kg bw/d in corn oil
Basis:
- No. of animals per sex per dose:
- 10 males and 10 females per group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Post-exposure period: no
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day (nominal)
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
RS-Freetext:
800 mg/kg bw/d:
-----ANIMAL OBSERVATIONS
mortality: death of 4/10 males and 2/10 females
signs of intoxication: languid behabior, prostration, sensitivity to touch, tremors, epistaxis, wheezing, dyspnea and/or polypnea, death
food consumption comparable to controls
body weight:
males: initiation to week 13: statistically significant decreased body weight gain, shown in a figure, mean terminal body weight was not significantly decreased: 489 g versus 571 g of control
females: body weight gain: not significnant different to control; mean terminal body weight was significantly decreased: 282 g vers. 321 g of controls
-----TERMINAL EVALUATIONS
ophthalmoscopic evaluation: no treatment-related effects observed
--Hematology:
values comparable to control values (data not shown)
--Clinical chemistry:
(significantly changed values vers. controls)
males:
BUN (33 vers. 11 mg/dl), Creatinine (1.0 vers. 0.5 mg/dl),
ALP (136 vers. 87 IU/L), Bilirubin (0.23 vers. 0.16mg/dl)
Sodium (139 vers. 143 mEq/L)
females:
female values comparable to respective control values
--Urinalysis:
pH-values:
significantly decreased in males (6.42 vers. 7.50 in controls) and in females (6.50 vers. 7.25 in controls)
all other parameteres were comparable to the respective control parameters (data not shown)
-----NECROPSY:
--Organ weights:
absolute organ weights [significant changes in organ-to-body weight ratios(%bw)] versus controls
-males:
brain: 2.18g [0.456 %bw] vers. 2.18g [0.386 %bw],
liver: 15.11g [3.134 %bw] vers. 14.97g [2.616 %bw]
kidneys: 4.12g [0.878 %bw] vers. 3.57g [0.628 %bw]
adrenal: 0.076g(sign.)[0.0164 %bw] vers. 0.059g[0.0104 %bw]
testes: no relevant changes:
control-high dose (rel weights): 5.26g (0.931 %bw) - 4.96g (1.016 %bw)
-females:
brain: 2.09g [0.742 %bw] vers. 2.05g [0.643 %bw]
liver: 9.82g [3.481 %bw] vers. 8.83g [2.748 %bw]
lungs: 1.24g(sign.)[0.439 %bw(not sign.)] vers. 1.41g [0.441 %bw] relative weights were unaffected
kidneys: 2.35g [0.835 %bw] vers. 2.22g [0.694 %bw]
heart: 1.05g [0.370 %bw] vers. 1.08g [0.377 %bw]
ovaries: no relevant changes:
control-high dose (rel weights): 0.163g (0.0512 %bw) - 0.0547g (0.0745 %bw)
----gross- and histopathology:
--kidneys:
males:
depressed areas, pale areas, mottled appearance, dilated renal pelvis, and/or granular/pitted/rough texture,
males and females:
chronic progressive nephropathy (degeneration and regeneration of the tubular epithelial cells, interstititial fibrosis, mononuclear cell infiltrates) in 10/10 treated and in 2/10 control males and in 9/10 treated females but not in control females
--liver:
males and females:
centrilobular hypertrophy of hepatocytes
--adrenal gland:
males and females:
hyperplasia of the zona fasciculata
--stomach:
males and females:
dark areas in the glandular portion, minimal mucosal erosion in the glandular portion in 2/10 males and 3/10 females
--testes and ovaries:
no pathological findings.
200 mg/kg bw/d:
-----ANIMAL OBSERVATIONS
no mortality, no signs of intoxication were reported
food consumption comparable to controls
body weight development comarable to respective controls, including terminal body weights
-----TERMINAL EVALUATIONS
ophthalmoscopic evaluation: no treatment-related effects observed
--Hematology:
values comparable to control values (data not shown)
--Clinical chemistry:
values comparable to control values
--Urinalysis
pH-values:
significantly decreased in males (6.80 vers. 7.50 in controls) and in females (6.35 vers. 7.25 in controls)
all other parameteres were comparable to the respective control parameters (data not shown)
-----NECROPSY:
--Organ weights:
values comparable to respective control values
--gross- and histopathology:
stomach:
males and females:
dark areas in the glandular portion,
female only: 1/10 with minimal mucosal erosion in the glandular portion
50 mg/kg bw/d:
-----ANIMAL OBSERVATIONS
no mortality, no signs of intoxication were reported
food consumption comparable to controls
body weight development comarable to respective controls, including terminal body weights
-----TERMINAL EVALUATIONS
ophthalmoscopic evaluation: no treatment-related effects observed
--Hematology:
values comparable to control values (data not shown)
--Clinical chemistry:
values comparable to control values
--Urinalysis
pH-values:
increased in males (7.75 vers. 7.50 in controls) and decreased in females (6.85 vers. 7.25 in controls)
all other parameteres were comparable to the respective control parameters (data not shown)
-----NECROPSY:
--Organ weights:
female:
lungs abs weight significantly decreased when compared to the respective control:1.28g vers. 1.41g; relative weights were unaffected
all other values of organ weights were comparable to respective control values
--gross- and histopathology:
stomach:
males and females:
dark areas in the glandular portion,
female only: 1/10 with minimal mucosal erosion in the glandular portion
Applicant's summary and conclusion
- Executive summary:
p-chlorotoluene was administered by gavage for 90 days to Sprague-Dawley-derived rats at dose levels of 50, 200 and 800 mg/kg/day. In the 90-day study, 4 of 10 males and 2 of 10 females in the high-dose group died due to treatment; survivors exhibited an adverse effect upon body weight, languid behavior, prostration, tremors, sensitive to touch, epistaxis and respiratory distress. In
the 90-day study, increases in alkaline phospthaase and creatinine (males on1y) , and increases in adrenal (absolute and relative,
females), kidney (relative, both sexes) and liver (relative, both sexes) weights were noted.
Histopathology findings of centrilobular hepatocellular hypertrophy, adrenal cortical hyperplasia and exacerbation of chronic progressive nephropathy confirmed the clinical laboratory and organ weight results. Animals receiving 50 or 200 mg/kg/day (90 days) did not exhibit treatment-related findings.
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