Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
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 (1978). Testing of twenty-one environmental aromatic amines or derivatives for long-term toxicity or carcinogenicity. J. Environm. Pathol. Toxicol. 2, 325-356.
- Year:
- 1 978
- Bibliographic source:
- J Environm Pathol Toxicol 2: 325-356.
- 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
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 452 (Chronic Toxicity Studies)
- Deviations:
- yes
- Remarks:
- Analytical purity not reported. Animals housing and enviromental conditons were not reported. Only two doses tested
- GLP compliance:
- no
- Remarks:
- GLP compliance was not mandatory at the time of the study
- Limit test:
- no
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
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles Riveres laboratories, USA
- Diet (e.g. ad libitum): animals were held on basal diet of Purina laboratory chow for two weeks before grouping for the toxicity or feeding studies
- Age at study initiation: 4-6 week-old animals
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23±2°C
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 18 months
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 1000, 2000 ppm (approx. 0,. 75, 150 mg/kg bw)
Basis:
nominal in diet
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Post-exposure period: 6 months
Examinations
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes. A complete gross was done on all animals which died after 6 months on test or were killed at the end of the experimental period of approximately 24 months
HISTOPATHOLOGY: Yes. Histopathological examinations were done on all grossly abnormal organs, tumor masses, lung, liver, spleen, kidney, adrenal, heart, bladder, stomach, intestines, reproductive organs, and pituitaries. - Statistics:
- Statistical analysis of tumors found was performed using the Fisher exact test with Bonferroni correction.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 2 000 ppm
- Sex:
- male
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
no mortality and no signs of toxicity are reported. Body weight development seems to correspond to the respective control group because body weight gain in the treated rats 10 % below that of the respective controls should result in a reduction of the dosage. No gross and no histopathological findings are reported.
Thus, under the condition of this investigation, the NOAEL(systemic toxicity) is 2000 ppm (approximately 150 mg/kg bw/day) Results on carcinogenicity: see endpoint studys 7.7
Applicant's summary and conclusion
- Executive summary:
Weisburger EK (1978):
25 male CD rats per group received doses of 0, 1000 and 2000 ppm p-toluidine in the diet for 18 months (corresponding to 0, 75 and 150 mg/kg bw/day) followed by a 6 months recovery period. A control group of 25 male rats received diet only. Doses were chosen due to preliminary 30-day feeding study followed by a 2-week recovery period (no details given). No mortality and no signs of toxicity are reported.
Body weight development seems to correspond to the respective control group because body weight gain in the treated rats 10 % below that of the respective controls should have resulted in a reduction of the dosage. No gross and no histopathological changes were discovered. Other examined parameters were not reported. Thus, under the conditions of this investigation, the
NOAEL (systemic toxicity) is 2000 ppm (approximately 150 mg/kg bw/day).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.