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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
Carcinogenicity
Administrative data
Description of key information
Carcinogenicity:
Chronic carcinogenicity study was performed to determine the carcinogenic nature of the test chemical. The study was performed using male rats for 24 months. The test chemical was mixed with feed at dose level of0, 3,000, or 6,000 ppm for 5 months followed by 0, 1,500 or 3,000 ppm for 13 months. Doses of 0, 79, or 303 mg/kg-day (based on time-weighted average concentrations of 0, 1,917, or 3,833 ppm) were calculated. Doses were lowered after 5 months of treatment; according to the study protocol, this action was taken either when there were treatment-related deaths or when body-weight gains in exposed animals were lower than corresponding controls by at least 10%. Rats were observed for up to 6 months after the end of the treatment period. Animals were monitored daily for mortality and clinical signs of toxicity. Body weights were recorded periodically. Complete necropsies were conducted on all animals that died after ≥6 months of treatment or at study termination. Histological examinations of grossly abnormal organs, tumor masses, the lung, liver, kidneys, spleen, adrenal, heart, bladder, stomach, intestines, reproductive organs, and pituitaries were performed. No significant increase in tumor incidence was observed in any group of rats. Based on the observations made, No observed adverse effect level (NOAEL) for male rats using 2, 4, 6 trichloroaniline is considered to be 303 mg/Kg/day since no significant increase in tumor incidence was observed in any group of rats.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: 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
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Chronic carcinogenicity study was performed to determine the carcinogenic nature of the test chemical
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- other: Charles River CD
- Details on species / strain selection:
- No data
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- No data
- Route of administration:
- oral: feed
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The test chemical was mixed with feed at dose level of 0, 3,000, or 6,000 ppm for 5 months followed by 0, 1,500 or 3,000 ppm for 13 months
DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data
VEHICLE
- Justification for use and choice of vehicle (if other than water): Feed
- Concentration in vehicle: 0, 79, or 303 mg/kg/day
- Amount of vehicle (if gavage): No data
- Lot/batch no. (if required): No data
- Purity: No data - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 24 months
- Frequency of treatment:
- Daily
- Post exposure period:
- 6 months
- Dose / conc.:
- 0 mg/kg bw (total dose)
- Dose / conc.:
- 79 mg/kg bw (total dose)
- Dose / conc.:
- 303 mg/kg bw (total dose)
- No. of animals per sex per dose:
- 0 mg/Kg/day: 25 males
79 mg/Kg/day: 25 males
303 mg/Kg/day: 25 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- No data
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Daily
- Cage side observations checked in table [No.?] were included. Mortality
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily
DERMAL IRRITATION (if dermal study): No data
- Time schedule for examinations: No data
BODY WEIGHT: Yes
- Time schedule for examinations: Periodically
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: No data
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
HAEMATOLOGY: No data
- Time schedule for collection of blood: No data
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data
CLINICAL CHEMISTRY: No data
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data
URINALYSIS: No data
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked in table [No.?] were examined. No data
NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data
OTHER: No data - Sacrifice and pathology:
- GROSS PATHOLOGY:
Yes, Complete necropsies were conducted on all animals that died after ≥6 months of treatment or at study termination.
HISTOPATHOLOGY:
Yes, Histological examinations of grossly abnormal organs, tumor masses, the lung, liver, kidneys, spleen, adrenal, heart, bladder, stomach, intestines, reproductive organs, and pituitaries were performed. - Other examinations:
- No data
- Statistics:
- No data
- Clinical signs:
- not specified
- Description (incidence and severity):
- No detailed data available
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Description (incidence):
- No detailed data available
- 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
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 303 mg/kg bw (total dose)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No tumor incidence was observed
- Critical effects observed:
- not specified
- Conclusions:
- The No observed adverse effect level (NOAEL) for male rats using 2,4,6 trichloroaniline is considered to be 303 mg/Kg/day since no significant increase in tumor incidence was observed in any group of rats.
- Executive summary:
Chronic carcinogenicity study was performed to determine the carcinogenic nature of the test chemical. The study was performed using male rats for 24 months. The test chemical was mixed with feed at dose level of0, 3,000, or 6,000 ppm for 5 months followed by 0, 1,500 or 3,000 ppm for 13 months. Doses of 0, 79, or 303 mg/kg-day (based on time-weighted average concentrations of 0, 1,917, or 3,833 ppm) were calculated. Doses were lowered after 5 months of treatment; according to the study protocol, this action was taken either when there were treatment-related deaths or when body-weight gains in exposed animals were lower than corresponding controls by at least 10%. Rats were observed for up to 6 months after the end of the treatment period. Animals were monitored daily for mortality and clinical signs of toxicity. Body weights were recorded periodically. Complete necropsies were conducted on all animals that died after ≥6 months of treatment or at study termination. Histological examinations of grossly abnormal organs, tumor masses, the lung, liver, kidneys, spleen, adrenal, heart, bladder, stomach, intestines, reproductive organs, and pituitaries were performed. No significant increase in tumor incidence was observed in any group of rats. Based on the observations made, No observed adverse effect level (NOAEL) for male rats using 2, 4, 6 trichloroaniline is considered to be 303 mg/Kg/day since no significant increase in tumor incidence was observed in any group of rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 303 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Data is from secondary source
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the data available for the test chemical. the test chemical 2, 4, 6 trichloroaniline (CAS no 634 -93 -5) is not likely to be carcinogenic as per the criteria mentioned in CLP regulation.
Additional information
Carcinogenicity:
Data available for the test chemical was reviewed to determine the toxic nature of 2, 4, 6 trichloroaniline. The studies are as mentioned below:
Chronic carcinogenicity study was performed to determine the carcinogenic nature of the test chemical. The study was performed using male rats for 24 months. The test chemical was mixed with feed at dose level of0, 3,000, or 6,000 ppm for 5 months followed by 0, 1,500 or 3,000 ppm for 13 months. Doses of 0, 79, or 303 mg/kg-day (based on time-weighted average concentrations of 0, 1,917, or 3,833 ppm) were calculated. Doses were lowered after 5 months of treatment; according to the study protocol, this action was taken either when there were treatment-related deaths or when body-weight gains in exposed animals were lower than corresponding controls by at least 10%. Rats were observed for up to 6 months after the end of the treatment period. Animals were monitored daily for mortality and clinical signs of toxicity. Body weights were recorded periodically. Complete necropsies were conducted on all animals that died after ≥6 months of treatment or at study termination. Histological examinations of grossly abnormal organs, tumor masses, the lung, liver, kidneys, spleen, adrenal, heart, bladder, stomach, intestines, reproductive organs, and pituitaries were performed. No significant increase in tumor incidence was observed in any group of rats. Based on the observations made, No observed adverse effect level (NOAEL) for male rats using 2, 4, 6 trichloroaniline is considered to be 303 mg/Kg/day since no significant increase in tumor incidence was observed in any group of rats.
In another study, Chronic carcinogenicity study was performed to determine the carcinogenic nature of the test chemical. The study was performed using male rats for 18 months. The test chemical was mixed with feed at dose level of 0, 6,000, or 12,000 ppm (0, 1,040, or 2,070 mg/kg-day for female mice and 0, 1,030, or 2,060 mg/kg-day for male mice). Rats were observed for up to 6 months after the end of the treatment period. Animals were monitored daily for mortality and clinical signs of toxicity. Body weights were recorded periodically. Complete necropsies were conducted on all animals that died after ≥6 months of treatment or at study termination. Histological examinations of grossly abnormal organs, tumor masses, the lung, liver, kidneys, spleen, adrenal, heart, bladder, stomach, intestines, reproductive organs, and pituitaries were performed.No significant increase in tumor incidence was observed in either exposed group of female mice. However, a dose-related, statistically significant (p < 0.025 ) increase in the incidence of vascular tumors (not further characterized) was observed in dosed male mice (56 and 75% for the low- and high-dose groups, respectively) compared to concurrent controls (13%) and compared to pooled controls from similarly designed experiments. The incidence of hepatocellular carcinomas in male mice was statistically significantly (p < 0.025 ) increased in the low-dose group—but not the high-dose group—compared to the incidence in pooled, but not concurrent, controls (incidences in the pooled control, concurrent control, low-dose, and high-dose groups were 7/99, 1/16, 5/18, and 1/16, respectively).The lack of a dose-response relationship suggests that the effect was not treatment related.
The data summarized above is however inappropriate to judge the carcinogenic potential of the test chemical due to lack of chemicals.
Based on the data available for the test chemical. the test chemical 2, 4, 6 trichloroaniline is not likely to be carcinogenic as per the criteria mentioned in CLP regulation.
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