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EC number: 203-403-1 | CAS number: 106-49-0
- 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
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Testing of twenty-one environmental aromatic amines or derivatives for long-term toxicity or carcinogenicity
- Author:
- Weisburger EK, Russfield AB, Homburger F, Bogner E, Van Dongen CG, Chu KC
- Year:
- 1 978
- Bibliographic source:
- J Environm Pathol Toxicol 2: 325-356.
- Reference Type:
- publication
- Title:
- Further studies on carcinogenicity of environmental chemicals including simple aromatic amines
- Author:
- Russfield AB, Homburger F, Weisburger EK, Weisburger JH (1973). Further studies on carcinogenicity of environmental chemicals including simple aromatic amines. Toxicol. Appl. Pharmacol. 25, 446-447.
- Year:
- 1 973
- Bibliographic source:
- Toxicol Appl Pharmacol 25: 446-447.
- Reference Type:
- secondary source
- Title:
- p-Toluidine - CAS No: 106-49-0 - SIDS Initial Assessment Report.
- Author:
- OECD
- Year:
- 2 005
- Bibliographic source:
- UNEP Publications
Materials and methods
- Principles of method if other than guideline:
- p-toluidine was tested for long-term toxicity by dietary administration to male mice.
- GLP compliance:
- no
- Remarks:
- GLP compliance was not mandatory at the time of the study
Test material
- Reference substance name:
- p-toluidine
- EC Number:
- 203-403-1
- EC Name:
- p-toluidine
- Cas Number:
- 106-49-0
- Molecular formula:
- C7H9N
- IUPAC Name:
- 4-methylaniline
- Details on test material:
- - Name of test material (as cited in study report): p-toluidine hydrochloride
- Analytical purity: no data
- Other:purified by treatment with charcoal, purity controlled by thin layer chromatography (no further data)
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 6-8 weeks
- Diet (e.g. ad libitum): purina certified rodent diet
- Acclimatization period: 2 weeks
Administration / exposure
- Route of administration:
- oral: feed
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 18 months
- Frequency of treatment:
- daily
- Post exposure period:
- 3 months
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
6 months: 0, 1000, 2000 ppm (approx. 0, 150, 300 mg/kg bw), 12 months: 0, 500, 1000 ppm (approx. 0, 75, 150 ppm)
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
0, 150 and 300 mg/kg bw/day
Basis:
actual ingested
corresponding values as calculated from diet intake
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Doses were chosen based on preliminary 30-day feeding study followed by a 2-week recovery period (no further information).
Initially 1000, 2000 ppm (approximately 150, 300 mg/kg bw/day) over feeding period of 3 months,
Reduction of doses after 3 months because weight gain was by 10 % below that observed in the concurrent controls: 500 and 1000 ppm ppm (approximately 75, 150 mg/kg bw/day)
Examinations
- Observations and examinations performed and frequency:
- BODY WEIGHT: Yes
- Sacrifice and pathology:
- NECROPSY: Animals which died during the first 6 month of treatment were discarded without necropsy. A complete gross necropsy was done on all animals which died after 6 months on test or were killed at the end of the study. Tissues were fixed, sectioned, and stained by hematoxylin and eosin.
HISTOPATHOLOGY: Histopathological examinations were done on all grossly abnormal organs, tumor masses, lung, liver, spleen, kidney, adrenal, heart, bladder, stomach, intestines, reproductive organs. - Statistics:
- Statistical analysis of tumors found was performed using the Fisher exact test with Bonferoni correction.
Results and discussion
Results of examinations
- Details on results:
- Result (carcinogenicity): positive
- Relevance of carcinogenic effects / potential:
- At both dose levels of p-toluidine in the oral feed a increase in hepatomas was observed, indicating a carcinogenic potential of the test substance.
Any other information on results incl. tables
Male mice at both dose levels exhibited a significant increase in hepatomas: concurrent control -- pooled control versus low dose -- high dose:
3/18 (16.7 %) -- 7/99 (7.1 %) versus 8/17 (47 %) -- 9/18 (50 %).
Female mice at high dose level also showed an increase in liver tumors: concurrent control -- pooled control versus low dose --
high dose:
0/20 (0 %) -- 1/102 (0.98 %) versus 2/21 (9.5 %) -- 3/17 (17.6 %)
Applicant's summary and conclusion
- Executive summary:
Weisburger (1978):
In a study over a period of 21 months 25 male and 25 female CD-1 mice were initially fed 0, 1000 and 2000 ppm p-toluidine hydrochloride (corresponding to 150 and 300 mg/kg bw/day) for a period of 6 months. Due to significantly decreased body weights (> 10 %) and increased mortality rate when compared to the concurrent controls doses were reduced to 0, 500 and 1000 ppm (corresponding to 0, 75 and 150 mg/kg bw/day) and given for further 12 months. After a 3 months post exposure observation period mice were killed and examined for gross and histopathological changes.
Male mice at both dose levels exhibited a significant increase in hepatomas: concurrent control -- pooled control versus low dose -- high dose: 3/18 (16.7 %) -- 7/99 (7.1 %) versus 8/17 (47 %) -- 9/18 (50 %). Female mice at high dose level also showed an increase in liver tumors: concurrent control -- pooled control versus low dose -- high dose: 0/20 (0 %) -- 1/102 (0.98 %) versus 2/21 (9.5 %) -- 3/17 (17.6 %)
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