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EC number: 202-088-8 | CAS number: 91-66-7
- 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:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary literature
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Repeated dose oral toxicity study of the test chemical
- Author:
- USEPA
- Year:
- 2 018
- Bibliographic source:
- HPVIS
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Subacute repeated dose oral toxicity study was performed to determine the toxic nature of the test chemical.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- N,N-diethylaniline
- EC Number:
- 202-088-8
- EC Name:
- N,N-diethylaniline
- Cas Number:
- 91-66-7
- Molecular formula:
- C10H15N
- IUPAC Name:
- N,N-diethylaniline
- Details on test material:
- - Name of test material: N,N-Diethylaniline
- Molecular formula: C10H15N
- Molecular weight: 149.236 g/mol
- Substance type: organic
- Physical state: solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 10, 50 or 250 mg/kg-bw/day
Basis:
no data
- No. of animals per sex per dose:
- unspecified
- Control animals:
- yes
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Clinical signs of toxicity consisted of increased frequency of respiratory sounds in males at 50 mg/kg-bw/day, and increased frequency of respiratory sounds and salivation in females at 250 mg/kg-bw/day.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- No mortalities observed.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Hematological effects (decreased red cell counts, decreased hemoglobin concentrations, decreased packed cell volume (PCV) in both sexes and increased mean corpuscular volume (MCV) and mean corpuscular hemoglobin (MCH) in females) were reported at all dose
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Histological effects were reported for the liver and spleen.
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not specified
- Details on results:
- HISTOPATHOLOGY:
Histological effects were reported for the liver and spleen. In the liver, hemosiderosis of the Kupffer cells at 10 mg/kg-bw/day and extra medullary hematopoeisis at 50 and 250 mg/kg-bw/day were observed. In the spleen, hemosiderosis, extramedullary hematopoiesis and splenic hyperemia were reported at 10 mg/kg-bw/day. Swollen spleens were observed at 50 and 250 mg/kg-bw/day. Increased absolute and relative weights and black pigmentation of the spleen were also reported at 10mg/kg-bw/day. At 50 and 250 mg/kg-bw/day, hyperbilirubinemia, polychromasia were reported, and at 250 mg/kg-bw/day, decreased potassium levels, histopathological findings in the kidneys of both sexes, black pigmentation in the kidneys of females, and increased albumin levels in males were reported.
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 10 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: based on hematological and histopathological changes in the spleen and liver consistent with hemolytic anemia
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The Low observed adverse effect level (LOAEL) for the test chemical using Wistar rats was considered to be 10 mg/kg-bw/day
- Executive summary:
In a subacute repeated-dose toxicity study, Wistar rats (male and female; number unspecified) were administered the test chemical via gavage at 0, 10, 50 or 250 mg/kg-bw/day, 7 days/week for 28 days. No mortalities were observed. No changes in body weight, food, and water consumption were reported. Clinical signs of toxicity consisted of increased frequency of respiratory sounds in males at 50 mg/kg-bw/day, and increased frequency of respiratory sounds and salivation in females at 250 mg/kg-bw/day. Hematological effects (decreased red cell counts, decreased hemoglobin concentrations, decreased packed cell volume (PCV) in both sexes and increased mean corpuscular volume (MCV) and mean corpuscular hemoglobin (MCH) in females) were reported at all doses (dose-response not specified). Histological effects were reported for the liver and spleen. In the liver, hemosiderosis of the Kupffer cells at 10 mg/kg-bw/day and extra medullary hematopoeisis at 50 and 250 mg/kg-bw/day were observed. In the spleen, hemosiderosis, extramedullary hematopoiesis and splenic hyperemia were reported at 10 mg/kg-bw/day. Swollen spleens were observed at 50 and 250 mg/kg-bw/day. Increased absolute and relative weights and black pigmentation of the spleen were also reported at 10mg/kg-bw/day. At 50 and 250 mg/kg-bw/day, hyperbilirubinemia, polychromasia were reported, and at 250 mg/kg-bw/day, decreased potassium levels, histopathological findings in the kidneys of both sexes, black pigmentation in the kidneys of females, and increased albumin levels in males were reported. Dose-response and statistical significance were not indicated for any of these observed effects. Based on hematological and histopathological changes in the spleen and liver consistent with hemolytic anemia observed the Low observed adverse effect level (LOAEL) for the test chemical using Wistar rats was considered to be 10 mg/kg-bw/day.
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