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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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on generations indicated in Effect levels (migrated information)
- 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 source .
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Provisional Peer-Reviewed Toxicity Values for- 2,4,6-Trichloroaniline (CASRN 634-93-5) and 2,4,6-Trichloroaniline Hydrochloride (CASRN 33663-50-2)
- Author:
- SRC, Inc
- Year:
- 2 010
- Bibliographic source:
- Superfund Health Risk Technical Support Center National Center for Environmental Assessment Office of Research and Development U.S. Environmental Protection Agency Cincinnati, OH 45268
- Reference Type:
- publication
- Title:
- Hygienic standardization of 2,4,6-trichloroaniline in water
- Author:
- Sapegin, DI; Fomochkin, IP; Pis’ko, GT; et al.
- Year:
- 1 985
- Bibliographic source:
- Gig Sanit 3:83–84,1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- A chronic reproductive toxicity study of 2, 4, 6-trichloroaniline iwas conducted in white male and female rats by oral gavage.
- GLP compliance:
- not specified
- 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
- Details on test material:
- - Name of test material (as cited in study report): 2,4,6-Trichloroaniline
- Molecular formula (if other than submission substance): C6-H4-Cl3-N
- Molecular weight (if other than submission substance): 196.464
- Substance type: Organic
- Physical state: Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 2,4,6-Trichloroaniline
- Molecular formula (if other than submission substance): C6-H4-Cl3-N
- Molecular weight (if other than submission substance): 196.464
- Substance type: Organic
- Physical state: Solid
Test animals
- Species:
- rat
- Strain:
- not specified
- Details on species / strain selection:
- White rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- other: not applicable
- Vehicle:
- other: Oil solution
- Remarks:
- Not specified
- Details on exposure:
- Details on exposure
PREPARATION OF DOSING SOLUTIONS: 2,4,6-trichloroaniline were mix with oil solution in the concentration of at doses of 0.4, 4, or 40 mg/kg-day, 5 days/week (adjusted to 0.3, 3, or 29 mg/kg-day).
VEHICLE
- Justification for use and choice of vehicle (if other than water): Oil solution were used
- Concentration in vehicle: 0, 0.3, 3 and 29 mg/kg/day - Details on mating procedure:
- The animals were mated at the end of the 6-month treatment period.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 6 months
- Frequency of treatment:
- 5days /week
- Details on study schedule:
- No data available
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.3, 3.0, and 29 mg/kg/day
Basis:
no data
- No. of animals per sex per dose:
- 120 males and 60 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- Observations and examinations performed & frequency
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
- Cage side observations checked in table [No.?] were included: Mortality was observed.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: On every 30 days throughout the treatment period.
BODY WEIGHT: Yes
- Time schedule for examinations: On every 30 days throughout the treatment period.
HAEMATOLOGY: Yes
- Time schedule for collection of blood: On every 30 days of treatment period.
- Anaesthetic used for blood collection: No data available
- Animals fasted: No data available
- How many animals: All 180 animals were examined.
- Parameters checked in table [No.?] were examined: Methemoglobin, conditioned reflexes, Concentration of formed elements and serum hemoglobin, Polychromaphilic and hypochromic RBCs and WBC were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: On every 30 days of treatment period.
- Animals fasted: No data available
- How many animals: All 180 animals were examined.
- Parameters checked in table [No.?] were examined: : Residual nitrogen, pyruvic acid, catalase, alanine aminotransferase [ALT] and aspartate aminotransferase [AST] levels, nitrogen and pyruvic acid in serum and lactate dehydrogenase (LDH), succinic dehydrogenase (SDH) and Chromosomal aberrations activities in the liver and kidney were examined. - Oestrous cyclicity (parental animals):
- Any irregularities in the estrous cycle ovogenesis were investigated.
- Sperm parameters (parental animals):
- Sperm parameters (parent animal)
Parameters examined in [all P] male parental generations : Spermatogenesis were observed - Litter observations:
- Number of live embreyos, Number of dead embreyos and numbers of fetuses/dam were observed
- Postmortem examinations (parental animals):
- Postmortem examinations (Parent Animal)
SACRIFICE
- Male animals: All surviving animals [describe when, e.g. as soon as possible after the last litters in each generation were produced.]: Yes
- Maternal animals: All surviving animals [describe when, e.g. after the last litter of each generation was weaned.]: Number of implantation sites was examined.
GROSS NECROPSY
- Gross necropsy consisted of [external and internal examinations including the cervical, thoracic and abdominal viscera.]: Yes, at the termination of study.
HISTOPATHOLOGY / ORGAN WEIGHTS
The tissues indicated in Table [#] were prepared for microscopic examination and weighed, respectively: Yes
Organ weights were examined.
Organ weighted:
Brain, Liver, kidneys and reproductive organs were examined. - Postmortem examinations (offspring):
- Postmortem examinations (offspring)
SACRIFICE
- The F1 offspring not selected as parental animals and all F2 offspring were sacrificed at [#?] days of age: No data available
- These animals were subjected to postmortem examinations (macroscopic and/or microscopic examination) as follows: Yes
GROSS NECROPSY
- Gross necropsy consisted of [external and internal examinations including the cervical, thoracic, and abdominal viscera.]: Embryotoxicity and teratogenicity were examined.
HISTOPATHOLOGY / ORGAN WEIGTHS
The tissues indicated in Table [#] were prepared for microscopic examination and weighed, respectively. : Yes, morphofunctional indices were examined. - Statistics:
- No data available
- Reproductive indices:
- Fertility index, gestation index and implantation index were examined.
- Offspring viability indices:
- No data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Description (incidence and severity):
- Body weight gain: In 29 mg/kg/day treated rat decreased in weight gain were observed as compared to control.
- Food consumption and compound intake (if feeding study):
- not specified
- Description (incidence and severity):
- Body weight gain: In 29 mg/kg/day treated rat decreased in weight gain were observed as compared to control.
- 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
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- effects observed, treatment-related
- Description (incidence and severity):
- Decreased numbers of fetuses/dam were observed in 3 mg/kg/day treated rat.
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- Pre- and postimplantation fetal mortality and decreased numbers of fetuses/dam were reported at the mid-dose
Details on results (P0)
No mortality was observed in treated rat as compared to control.
Effect levels (P0)
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 3 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Effect on weight gain, hematology, clinical chemistry, oxygen consumption, organ weight, gross pathology, histopathology and reproductive performance
- Remarks on result:
- other: Significant effect were observed
- Dose descriptor:
- NOAEL
- Effect level:
- 0.3 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No adverse effect on survival, body weight gain, hematology, clinical, chemistry, gross pathology, histopathology and reproductive performance
- Remarks on result:
- other: No significant effect were observed at this dose.
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
Details on results (F1)
Pre and postimplantation fetal mortality were observed in 3 mg/kg/day treated rat.
Effect levels (F1)
open allclose all
- Dose descriptor:
- LOAEL
- Generation:
- F1
- Effect level:
- 3 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Effect on survival of fetus
- Remarks on result:
- other: Effect were observed
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 0.3 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: No significant effect were observed
- Remarks on result:
- other: No significant effect were observed at this dose
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEL and LOAEL was considered to be 0.3 mg/kg/day and 3 mg/kg/day for F0 generation respectively and LOAEL was considered to be 3 mg/kg/day for F1 generation when rats were treated with 2, 4, 6 trichloroaniline orally for 6 months.
- Executive summary:
In a chronic reproductive toxicity study, white male and female rats were exposed to 2, 4, 6 trichloroaniline in the concentrations of 0, 0.3, 3 and 29 mg/kg/day by oral gavage. The results showed that 2, 4, 6 trichloroaniline is toxic at higher doses. Toxic changes were observed as decreased in weight gain,increased numbers of hypochromic RBCs and doubled levels of methemoglobin, Anisocytosis, poikilocytosis, reticulocytosis, hypochromia and presence of Heinz bodies in the RBCs and decreased in SDH and LDH activities in liver and the kidney of 29 mg/kg/day treated rat. Increased relative weights of brain and decreased liver weight. In addition, Degenerative changes and evidence of hemorrhage in the myocardium, kidneys, liver, spleen and brain in 29 mg/kg/day treated rats. Decreased numbers of fetuses/dam and massive hematomas were observed in abdominal cavities of 3 mg/kg/day treated rat of F0 generation. In F1 generation, Pre and postimplantation fetal mortality were also observed in 3 mg/kg/day treated rat. Therefore, LOAEL was considered to be 3 mg/kg/day for F0 and F1 generation and NOAEL was considered to be 0.3 mg/kg/day for F0 generation when rats were treated with 2, 4, 6 trichloroaniline orally for 6 months. This study is limited by inadequate data reporting, including the strain, size, and sex distribution of the control and treatment groups, the methods utilized,and the endpoints evaluated.
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