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EC number: 211-219-8 | CAS number: 634-93-5
- 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:
- disregarded due to major methodological deficiencies
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was not conducted according to guidelines, nor under a quality assurance system. Furthermore, the method description lacks key details regarding the testing conditions (test material purity/impurities, no information on vehicle identity or purity, no information on housing and handling of the test animals) and the number of test animals used is non-standard.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The aim of the experiment was studying cumulative properties of the substance and selecting the method for chronic study.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 2,4,6-trichloroaniline
- EC Number:
- 211-219-8
- EC Name:
- 2,4,6-trichloroaniline
- Cas Number:
- 634-93-5
- Molecular formula:
- C6H4Cl3N
- IUPAC Name:
- 2,4,6-trichloroaniline
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Substance type: White crystalline powder
- Physical state: Solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: white
- Sex:
- male/female
Administration / exposure
- Route of administration:
- other: introduced intra-peritoneally
- Vehicle:
- other: oil solution
- Details on oral exposure:
- VEHICLE
- Justification for use and choice of vehicle (if other than water): solubility in distilled water at 20°C is 26 mg/l and at 30°C – 40 mg/l
- Concentration in vehicle: 8 % oil solution - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 45 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
80 mg/kg bw, 8% in oil solution
Basis:
other: introduced intra-peritoneally
- Remarks:
- Doses / Concentrations:
160 mg/kg bw, 8% in oil solution
Basis:
other: introduced intra-peritoneally
- Remarks:
- Doses / Concentrations:
800 mg/kg bw, 8% in oil solution
Basis:
other: introduced intra-peritoneally
- No. of animals per sex per dose:
- 128 white rats of both genders.
- Control animals:
- yes, concurrent no treatment
Examinations
- Observations and examinations performed and frequency:
- Before the start, on day 10, 20, 30 and 45 of the treatment blood assay was conducted to detect content of forming elements and hemoglobin quantity, nitrogen residues, pyruvic acid, catalase activity, alanine-amino-transferase (ALT) and aspartame-amino-transferase (AST) in blood serum, electrocardiogram in the second compartment, oxygen intake and bodyweight dynamic.
At the end of the experiment absolute and relative mass of internal body organs was measured as well as activity of lactate- and succinate-dehydrogenase in them (LDH and SDH respectively), histological study of testicles and ovary was also conducted.
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Slower.
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- Hematuria.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- effects observed, treatment-related
- Description (incidence and severity):
- Lethargy.
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Increase of relative mass of heart, liver, kidneys and spleen
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Cyanosis, hair fall.
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Clinical signs for dosage of 800 mg/kg bw/day:
BODY WEIGHT AND WEIGHT GAIN
The recorded bodyweight gain slowed down in the experimental rats compare to the control group.
HAEMATOLOGY
Hematuria was observed along with significant decrease of the hemoglobin content (on the 45th day: 12,08 ± 2,08 g% in the experimental group compare to 15,88 ± 0,82 g% in the control group, P<0,02) and of the erythrocytes (4,63 ± 0,79 million and 6,38 ± 0,25 million respectively, P<0,001). On the other hand was reported an increase of the quantity of hypochromic and polychromatophyllic erythrocytes, anyzocytosis, poykilocytosis and reticulocytosis, first leukocytosis with a later trend to leukopenia.
CLINICAL CHEMISTRY
A significant activity increase of ALT (4,69 ± 0,5 mmole in the experimental group compare to 2,57 ± 0,37 mmole in the control group, P<0,001) and of AST (3,74 ± 0,45 mmole and 2,95 ± 0,27 mmole respectively, P<0,001) was observed with a decrease ratio of activity of AST and ALT, which proves the dominating position of the liver. There was an increase of residue nitrogen (45,5 ± 6 mg% in the experimental group and 34 ± 2,4 mg% in the control group, P<0,001) and of pyruvic acid (2,36 ± 0,32 and 1,67 ± 0,1 mg% respectively, P<0,001). The activity of catalase was reduced (catalase index 0,18 ± 0,13 in experimental group and 1,04 ± 0,11 in control, P<0,001) as well as oxygen intake (42,2 ± 6,3 and 56,4 ± 7,2 ml/100 g for 15 min, P<0,01). SDH and LDH activity was inhibited in the liver and kidneys.
NEUROBEHAVIOUR
Lethargy.
ORGAN WEIGHTS
Increase of relative mass of heart, liver, kidneys and spleen.
GROSS PATHOLOGY
Cyanosis, hair fall, dystrophic changes and patchy hemorrhages in myocardium, liver, kidneys, brain and spleen.
OTHER FINDINGS
Similar but weaker symptoms were recorded in rats with Trichloroaniline dosage of 160 mg/kg. Dosage of 80 mg/kg was considered to be threshold as it showed non-significant deviations of some of the above mentioned parameters.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 80 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Introduction in sub-chronic studies of the test item at dosage of 800 mg/kg bw/day led to decrease of coefficients of mass and volume of testicles, increase of numbers of tubuleswithdesquamatedspermatogenic epithelium, which may be resulted by general not specific toxic impact. Lower dosages did not cause changes of the tubule structure. All the tested dosages did not demonstrate structural and functional changes of ovaries.
Applicant's summary and conclusion
- Conclusions:
- The NOEL is 80 mg/kg bw per day.
- Executive summary:
To assess the toxicity potentialThe test item in a solution within an oil vehicle was administered intra-peritoneally. Three doses were chosen to conduct the experiment (80, 160 and 800 mg/Kg bw/day) over 45 days. The test animals were examined before the beginning of the experiment, then on day 10, 20, 30 and 45. The NOEL is 80 mg/kg bw per day.
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