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Diss Factsheets
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EC number: 204-419-1 | CAS number: 120-71-8
- 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:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Insufficient description of study parameters and study results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Guideline:
- other: guideline not specified
- Deviations:
- not applicable
- Principles of method if other than guideline:
- dose range finding study for carcinogenicity study
- GLP compliance:
- no
- Remarks:
- prior to GLP implementation
- Limit test:
- no
Test material
- Reference substance name:
- 6-methoxy-m-toluidine
- EC Number:
- 204-419-1
- EC Name:
- 6-methoxy-m-toluidine
- Cas Number:
- 120-71-8
- Molecular formula:
- C8H11NO
- IUPAC Name:
- 2-methoxy-5-methylaniline
- Details on test material:
- - Name of test material (as cited in study report): p-Cresidine
- Analytical purity: 98.9 +- 0.1 %
Constituent 1
Test animals
- Species:
- other: rats (F344) and mice (B6C3F1), 5/sex/group
- Strain:
- other: Fischer F 344(rats) and B6C3F1 (mice)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Upon arrival a sample of animals was examined for parasites and other signs of disease. Animals to be used in the chronic study were quarantined by species for 2 weeks prior to initiation of test. All animals were housed by species in rooms having a temperature range of 23 °C to 34°C. Incoming air was filtered through Tri-Dek 15/40 denier Dacron filters providing six changes of room air per hour. Fluorescent light was provided on a 12 hour daily cycle. Food and water were available ad libitum.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: acetone / diet
- Details on oral exposure:
- the p-cresidine was dissolved with an appropriate amount of acetone (0.016 Vol-% of the final mix) with the help of mortar and pestle. This liquid mixture was hand-blended in an aluminium bowl with an aliquaot of the ground feed until all liquid was adsorbed and visual homogeneity was attained. This premix was then placed into a 6 kg capacity Patterson-Kelley standard model twin-shell stainless steel V-blender along with the remainder of the diet. The blender was sealed and operated for 20 minutes. The mixture was then emptied into stainless steel trays and allowed to sit under the exhaust hood for 2.5 hours while being stirred with a glass rod every 0.5 hour, allowing evaporation of a large protion of the acetone. Prrpared diets wre placed in double clear plastic bags and stored in the dark at 4°C. Diets were prepared weekly and any unused protions were discarded after 2 weeks
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 8 weeks
- Frequency of treatment:
- via the diet, available ad libitum
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 1.0, 3.0 % in diet
Basis:
nominal in diet
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, plain diet
- Details on study design:
- In order to establish the maximum tolerated concentrations of p-cresidine for administration to dosed animals in the chronic studies, subchronic tests were conducted with both rats and mice. Animals of each species were distributed amomg 3 groups, each consiting of 5 males and 5 females. p-Cresidine was administered to two of the three groups of each species at dietary concentrations of 1.0 and 3.0 % for 8 weeks. The third group of each species served as control group, receiviung only the basal laboratory diet.
Examinations
- Observations and examinations performed and frequency:
- As deaths occurred among all groups except male rats receiving 3.0 % p-cresidine in the feed, the high concentration chosen for the chronic study was 1.0 % p-cresidine for both rats and mice
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- mortality
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- mortality
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Deaths occurred among all groups except male rats receiving 3.0 % p-cresidine in the feed
Effect levels
open allclose all
- Dose descriptor:
- conc. level: 30000 mg/kg diet
- Effect level:
- 30 000 mg/kg diet
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: mortality
- Dose descriptor:
- conc. level: 30000 mg/kg diet
- Effect level:
- 30 000 mg/kg diet
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: no mortality
- Dose descriptor:
- conc. level: 10000 mg/kg diet
- Effect level:
- 10 000 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: mortality
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Mortality occurred among all groups except male rats receiving 3.0 percent p-cresidine in the feed.
- Executive summary:
Mortality occurred among all groups except male rats receiving 3.0 percent p-cresidine in the feed.
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