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EC number: 281-876-3 | CAS number: 84051-87-6
- 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
Repeated dose toxicity: Oral
The No Observed Adverse Effect Level (NOAEL) for the test chemical using male and female rats is considered to be in a dose range of 968- 1200 mg/Kg/day.
Repeated dose toxicity: Inhalation
According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance of 2-({4-[ethyl(2-hydroxyethyl)amino]phenyl}diazenyl)-6-methoxy-3-methyl-1,3-benzothiazol-3-ium acetate(84051-87-6) which is reported as 7.15E-15 mm Hg at 25 C. Thus, exposure to inhalable dust, mist and vapour of the chemical of 2-({4-[ethyl(2-hydroxyethyl)amino]phenyl}diazenyl)-6-methoxy-3-methyl-1,3-benzothiazol-3-ium acetate is highly unlikely. Therefore this study is considered for waiver.
Repeated dose toxicity: Dermal
The acute toxicity value for 2-({4-[ethyl(2-hydroxyethyl)amino]phenyl}diazenyl)-6-methoxy-3-methyl-1,3-benzothiazol-3-ium acetate(84051-87-6) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that 2-({4-[ethyl(2-hydroxyethyl)amino]phenyl}diazenyl)-6-methoxy-3-methyl-1,3-benzothiazol-3-ium acetate shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that 2-({4-[ethyl(2-hydroxyethyl)amino]phenyl}diazenyl)-6-methoxy-3-methyl-1,3-benzothiazol-3-ium acetate shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- chronic toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data from handbook or collection of data
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- WoE preapared from various publication mention below
1,Chronic repeated dose oral toxicity study was performed to evaluate the toxic nature of the test chemical.
2,Subacute repeated dose oral toxicity study was performed to evaluate the toxic nature of the test chemical - GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- other: 1. Albino 2. No data
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 1. No data
2. No data - Route of administration:
- other: 1. Feed 2. No data
- Details on route of administration:
- No data
- Vehicle:
- other: Feed
- Details on oral exposure:
- 1. PREPARATION OF DOSING SOLUTIONS: The test chemical was mixed with diet at dose levels of 0, 0.25, 1.0 or 3.0 % (0, 100, 400, 1200 mg/kg/day)
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): Diet
- Concentration in vehicle: 0, 0.25, 1.0 or 3.0 % (0, 100, 400, 1200 mg/kg/day)
- Amount of vehicle (if gavage): No data
- Lot/batch no. (if required): No data
- Purity: No data
2. No data - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 1. 2 years
2. No data - Frequency of treatment:
- Daily
- Remarks:
- 0, 0.25, 1.0 or 3.0 % (0, 100, 400, 1200 mg/kg/day) / 1
- Remarks:
- No data/ 2
- No. of animals per sex per dose:
- 1. Total: 160 males and 160 females
0 mg/Kg/day: 80 males and 80 females
100 mg/Kg/day: 25 males and 25 females
400 mg/Kg/day: 25 males and 25 females
1200 mg/Kg/day: 25 males and 25 females
2. No data - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- No data
- Observations and examinations performed and frequency:
- 1. CAGE SIDE OBSERVATIONS: Yes
- Time schedule: No data
- Cage side observations checked in table [No.?] were included. Appearance and behavior of test rats, mortality
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: No data
BODY WEIGHT: Yes
- Time schedule for examinations: No data
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- 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: Yes
- 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. Hematocrit and hemoglobin values
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. Bilirubunuria
URINALYSIS: Yes
- 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
2. CAGE SIDE OBSERVATIONS: No data
- Time schedule: No data
- Cage side observations checked in table [No.?] were included. No data
DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule: No data
BODY WEIGHT: No data
- Time schedule for examinations: No data
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: Yes
- 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: Yes
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. Liver function tests were impaired
URINALYSIS: Yes
- 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:
- 1. GROSS PATHOLOGY: Yes, any gross changes in the organs or viscera attributable to the test material were noted
HISTOPATHOLOGY: Yes
2. No data - Other examinations:
- 1. No data
- Statistics:
- 1. No data
2. No data - Clinical signs:
- no effects observed
- Description (incidence and severity):
- 1. Appearance and behavior of the test rats were generally comparable to those of the controls.
2. No data - Mortality:
- no mortality observed
- Description (incidence):
- 1. No mortality was observed in the treated rats
2. No data - Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- 1. At the 3% level (1200 mg/Kg/day), food consumption was significant lower than controls for the first six months but comparable to controls during the remainder of the study
2. No data - 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):
- 1. Significantly lower hematocrit and hemoglobin values in comparison with controls were obtained at all time intervals except 24 months for the males fed 3%. No such effect was noted in the females.
2. Normocytic anemia was noted at the highest dose level - Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 1. Bilirubinuria was observed at 24 months in male and female at 1% and females at 3%.
2. Liver function tests impaired - Urinalysis findings:
- not specified
- Description (incidence and severity):
- 2. Proteinuria was observed
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 1. The test animals sacrificed at 52 weeks did not present any gross changes in the organs or viscera attributable to the test material. Autopsies performed on the animals which died during the second year of the study did not reveal any consistent gross changes.
2. No data - Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- 1. Microscopic findings at two years revealed no compound related effects on the kidneys or other tissues in either sex.
2. No data - Histopathological findings: neoplastic:
- not specified
- Dose descriptor:
- NOAEL
- Remarks:
- 1
- Effect level:
- 1 200 other: mg/Kg/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects were noted at the mentioned dose level
- Dose descriptor:
- NOAEL
- Remarks:
- 2
- Effect level:
- 968 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: No adverse effects were noted at the mentioned dose level
- Critical effects observed:
- not specified
- Conclusions:
- The No Observed Adverse Effect Level (NOAEL) for the test chemical using male and female rats is considered to be in a dose range of 968- 1200 mg/Kg/day.
- Executive summary:
Data available for the test chemicals was reviewed to determine the toxic nature of test chemical . The studies are as mentioned below:
Chronic repeated dose oral toxicity study was performed to evaluate the toxic nature of the test chemical. Male and female albino rats were used in the study. The test compound was mixed with diet and used at dose levels of 0, 0.25, 1.0 or 3.0 % (0, 100, 400, 1200 mg/kg/day). The rats were treated for 2 years. The treated animals were noted for clinical signs, mortality, chenges in food consumption, hematology, blood chemistry, gross pathology and histopathology. Appearance and behavior of the test rats were generally comparable to those of the controls. No mortality was observed in the treated rats. At the 3% level (1200 mg/Kg/day), food consumption was significant lower than controls for the first six months but comparable to controls during the remainder of the study. Significantly lower hematocrit and hemoglobin values in comparison with controls were obtained at all time intervals except 24 months for the males fed 3%. No such effect was noted in the females. Bilirubinuria was observed at 24 months in male and female at 1% and females at 3%. The test animals sacrificed at 52 weeks did not present any gross changes in the organs or viscera attributable to the test material. Autopsies performed on the animals which died during the second year of the study did not reveal any consistent gross changes. Microscopic findings at two years revealed no compound related effects on the kidneys or other tissues in either sex. Based on the observations made, the No Observed Adverse Effect Level (NOAEL) for the test chemical using male and female Albino rats is considered to be 1200 mg/Kg/day.
Subacute repeated dose oral toxicity study was performed to evaluate the toxic nature of the test chemical. The study was performed using rats for 30 days. During the study period,Normocytic anemia was noted at the highest dose level. Liver function tests impaired and proteinuria was observed. Based on the observations made, No Observed Adverse Effect Level (NOAEL) for the test chemical using rats is considered to be 968 mg/Kg/day.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 200 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Data is from K2 source
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Waiver
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Waiver
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The data available for the test chemical was reviewed to determine the toxic nature of 2-({4-[ethyl(2-hydroxyethyl)amino]phenyl}diazenyl) -6-methoxy-3-methyl -1,3-benzothiazol -3-ium acetate(84051-87-6) repeated exposure by oral route. The study is as mentioned below:
Repeated oral study:
Chronic repeated dose oral toxicity study was performed to evaluate the toxic nature of the test chemical. Male and female albino rats were used in the study. The test compound was mixed with diet and used at dose levels of 0, 0.25, 1.0 or 3.0 % (0, 100, 400, 1200 mg/kg/day). The rats were treated for 2 years. The treated animals were noted for clinical signs, mortality, and changes in food consumption, hematology, blood chemistry, gross pathology and histopathology. Appearance and behavior of the test rats were generally comparable to those of the controls. No mortality was observed in the treated rats. At the 3% level (1200 mg/Kg/day), food consumption was significant lower than controls for the first six months but comparable to controls during the remainder of the study. Significantly lower hematocrit and hemoglobin values in comparison with controls were obtained at all time intervals except 24 months for the males fed 3%. No such effect was noted in the females. Bilirubinuria was observed at 24 months in male and female at 1% and females at 3%. The test animals sacrificed at 52 weeks did not present any gross changes in the organs or viscera attributable to the test material. Autopsies performed on the animals which died during the second year of the study did not reveal any consistent gross changes. Microscopic findings at two years revealed no compound related effects on the kidneys or other tissues in either sex. Based on the observations made, the No Observed Adverse Effect Level (NOAEL) for the test chemical using male and female Albino rats is considered to be 1200 mg/Kg/day.
Subacute repeated dose oral toxicity study was performed to evaluate the toxic nature of the test chemical. The study was performed using rats for 30 days. During the study period,Normocytic anemia was noted at the highest dose level. Liver function tests impaired and proteinuria was observed. Based on the observations made, No Observed Adverse Effect Level (NOAEL) for the test chemical using rats is considered to be 968 mg/Kg/day.
Repeated inhalation study:
According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance of 2-({4-[ethyl(2-hydroxyethyl)amino]phenyl}diazenyl)-6-methoxy-3-methyl-1,3-benzothiazol-3-ium acetate(84051-87-6) which is reported as 7.15E-15 mm Hg at 25 C. Thus, exposure to inhalable dust, mist and vapour of the chemical of 2-({4-[ethyl(2-hydroxyethyl)amino]phenyl}diazenyl) -6-methoxy-3- methyl-1,3-benzothiazol-3-ium acetate is highly unlikely. Therefore this study is considered for waiver.
Repeated dermal study;
The acute toxicity value for 2-({4-[ethyl(2-hydroxyethyl)amino]phenyl}diazenyl)-6-methoxy-3-methyl-1,3-benzothiazol-3-ium acetate(84051-87-6) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that 2-({4-[ethyl(2-hydroxyethyl)amino]phenyl}diazenyl)-6-methoxy-3-methyl-1,3-benzothiazol-3-ium acetate shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that 2-({4-[ethyl(2-hydroxyethyl)amino]phenyl}diazenyl)-6-methoxy-3-methyl-1,3-benzothiazol-3-ium acetate shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.
Based on the data available for the test chemical 2-({4-[ethyl(2-hydroxyethyl)amino]phenyl}diazenyl)-6-methoxy-3-methyl-1,3-benzothiazol-3-ium acetate(84051-87-6) not likely to exhibit toxic nature upon repeated exposure by oral, inhalation and dermal route of exposure and hence is not likely to classify as per the criteria mentioned in CLP regulation.
Justification for classification or non-classification
Based on the data available for the test chemical 2-({4-[ethyl(2-hydroxyethyl)amino]phenyl}diazenyl)-6-methoxy-3-methyl-1,3-benzothiazol-3-ium acetate(84051-87-6) not likely to exhibit toxic nature upon repeated exposure by oral, inhalation and dermal route of exposure and hence is not likely to classify as per the criteria mentioned in CLP regulation.
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