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EC number: 203-607-0 | CAS number: 108-69-0
- 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
Endpoint summary
Administrative data
Description of key information
OECD 407, GLP, rats,: NOEL 10 mg/kg/day for males and females.
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Qualifier:
- according to guideline
- Guideline:
- other: Guideline for 28-day repeated dose toxicity testing of chemicals (Japan)Japanese
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 1 per day
- Dose / conc.:
- 10 mg/kg bw/day (nominal)
- Remarks:
Basis:
no data- Dose / conc.:
- 60 mg/kg bw/day (nominal)
- Remarks:
- Basis:
no data - Dose / conc.:
- 360 mg/kg bw/day (nominal)
- Remarks:
- Basis:
no data - No. of animals per sex per dose:
- 6 and 12 (0 and 360 mg/kg)
- Control animals:
- yes, concurrent vehicle
- Dose descriptor:
- NOEL
- Effect level:
- 10 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Critical effects observed:
- not specified
- Conclusions:
- The NOEL is considered to be 10 mg/kg/day for males and females.
- Executive summary:
3,5-Dimethylaniline was studied for oral toxicity in rats in a GLP 28-day repeated dose toxicity test according to OECD Guideline 407 at doses of 0, 10, 60 and 360 mg/kg. The NOEL is considered to be 10 mg/kg/day for males and females.
Reference
Abstract from original report from JECDB-Database 2012:
3,5-Dimethylaniline was studied for oral toxicity in rats in a 28-day repeat dose toxicity test at doses of 0, 10, 60 and 360 mg/kg.
Cyanosis, blanching, salivation, exophthalmos and staggering gait were observed in males and/or females of the 360 mg/kg group, along with decreased body weight gain and food consumption. Urinalysis showed increase in urine volume, increases in sodium, potassium and chloride excretion, and decreases in osmotic pressure and specific gravity in males and females of the 360 mg/kg group. Hematological examination showed increases in methemoglobin and reticulocytes, and decreases in erythrocytes, hemoglobin and hematocrit in males and females of the 60 mg/kg and 360 mg/kg groups. Further, increase in leukocytes in males and females of the 360 mg/kg group, increase in segmented neutrophils in males of the 360 mg/kg group, and shortening of activated partial thromboplastin time in females of the 360 mg/kg group were detected. Blood chemical examination showed increases in total bilirubin, GOT, GPT, phospholipids and inorganic phosphorus in males and females of the 360 mg/kg group. Further, decreases in potassium and chloride in males of the 360 mg/kg group, and increases in total cholesterol and calcium in females of the 360 mg/kg group were detected. Spleen weights were increased in males and females of the 60 mg/kg and 360 mg/kg groups, and the thyroid, liver and kidney weights in both sexes of the 360 mg/kg group. In addition, the testis weights were increased in the 360 mg/kg group. Histopathologically, hemosiderin deposits in the liver and spleen, and extramedullary hematopoiesis of the spleen were apparent in males and females of the 60 mg/kg and 360 mg/kg groups. Hemosiderin deposits in the kidney and extramedullary hematopoiesis in the liver were also observed in males and females of the 360 mg/kg group. Hypertrophy of hepatocytes and follicular cells in the thyroid was noted in males of the 60 mg/kg group and males and females of the 360 mg/kg group. In the kidney, papillary necrosis was observed in males and females of the 360 mg/kg group, and hyaline droplets in the tubular epithelium in males of the 360 mg/kg group. In the recovery test, papillary necrosis in the kidney, and hemosiderin deposit in the liver, spleen and kidney persisted in males and females of the 360mg/kg group. However, the other changes observed during the administration period demonstrated recovery. The NOEL is considered to be 10 mg/kg/day for males and females.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Guideline study
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
No classification is warranted according to Regulation (EC) No 1272/2008 based on the findings of an OECD 407 guideline study.
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