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EC number: 280-898-0 | CAS number: 83803-79-6
- 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
Prediction done using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound N-(4-((4-(dimethylamino)phenyl)(4-(phenylamino)naphthalen-1-yl)methylene)cyclohexa-2,5-dienylidene)-..(83803-79-6).The study assumed the use of male and female Wistar rats in subacute study of 28 days. No significant alterations were noted at the dose level of 589.33 mg/Kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for N-(4-((4-(dimethylamino)phenyl)(4-(phenylamino)naphthalen-1-yl)methylene)cyclohexa-2,5-dienylidene)-..(83803-79-6) is considered to be 462.0mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation.
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:
- 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.
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- To evaluate the toxic effect of Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2- yl)amino]stilbene-2,2'-disulfonate in rats by oral gavage for 2 years.
- GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report):disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate- Molecular formula ; C40H40N12O8S2.2Na- Molecular weight ; 924.928gm/mol- Substance type:Organic
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Not specified
- Route of administration:
- oral: unspecified
- Details on route of administration:
- Not specified
- Vehicle:
- not specified
- Details on oral exposure:
- Not specified
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- Not specified
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- Not specified
- Remarks:
- 0,51,71 and 524 and 791 mg/kg bw/day for males and females, respectively
- No. of animals per sex per dose:
- Not specified
- Control animals:
- not specified
- Details on study design:
- Not specified
- Positive control:
- Not specified
- Observations and examinations performed and frequency:
- Observations and examinations performed & frequencyCAGE SIDE OBSERVATIONS: Yes DETAILED CLINICAL OBSERVATIONS: Yes BODY WEIGHT: Not specified FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Not specified- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Not specifiedFOOD 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: Not specifiedWATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not specifiedOPHTHALMOSCOPIC EXAMINATION: Not specifiedHAEMATOLOGY: Yes CLINICAL CHEMISTRY: Yes URINALYSIS: Not specifiedNEUROBEHAVIOURAL EXAMINATION: Not specifiedOTHER:
- Sacrifice and pathology:
- Sacrifice and pathologyGROSS PATHOLOGY: Not specifiedHISTOPATHOLOGY: Yes
- Other examinations:
- Not specified
- Statistics:
- Not specified
- Clinical signs:
- not specified
- Mortality:
- not specified
- 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:
- no effects observed
- Description (incidence and severity):
- No significant effect were observed at the at all dose level 0,51,71 and 524 and 791 mg/kg bw/day for males and females, respectively in treated group compare to control
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No significant effect were observed at the at all dose level 0,51,71 and 524 and 791 mg/kg bw/day for males and females, respectively in treated group compare to control
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant effect were observed on the kidney weight of dose level 524 and 791 mg/kg bw/day for males and females, respectively in treated group compare to control.
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No significant effect were observed at the at all dose level 0,51,71 and 524 and 791 mg/kg bw/day for males and females, respectively in treated group compare to control.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 524 other: mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No significant effects were observed at the clinical sign, Hematology, clinical chemistry and histopathology
- Remarks on result:
- other: No toxic effect were observed
- Dose descriptor:
- NOAEL
- Effect level:
- 791 other: mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No significant effects were observed at the clinical sign, Hematology, clinical chemistry and histopathology
- Remarks on result:
- other: No toxic effect were observed
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Conclusions:
- NOAEL was considered to be 524 and 791 mg/kg bw/day for males and females rats , respectively in rats by oral route for Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulfonate for 2 years study.
- Executive summary:
In a repeated dose toxicity studies forDisodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino] stilbene-2,2'-disulfonate in male and female rats for vwas evaluated for its toxic effect. The test substance was exposed at the concentration of0,51,71 and 524 and 791 mg/kg bw/day for males and females, respectively for 28 days. The animals were observed for clinical sign, Hematology, clinical chemistry, organ weight and histopathology. As though a significant were observed on the kidney weight of dose level 524 and 791 mg/kg bw/day for males and females, respectively in treated group compare to control but no effect observed in the histopathology of kidney. No significant effects were observed at the clinical sign, Hematology, clinical chemistry and histopathology at all dose level. Therefore NOAEL was considered to be 524 and 791 mg/kg bw/day for males and females, respectively for 2 years study for Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino] stilbene-2,2'-disulfonate.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 589.33 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- K2 data form OECD QSAR 3.4.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
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
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose oral toxicity:
Prediction model based estimation and data available for the target chemical was reviewed to determine the toxic nature of N-(4-((4-(dimethylamino)phenyl)(4-(phenylamino)naphthalen-1-yl)methylene)cyclohexa-2,5-dienylidene)-..(83803-79-6) upon repeated exposure by oral, dermal and inhalation route of exposure. The studies are as mentioned below:
Based on the prediction done using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound N-(4-((4-(dimethylamino)phenyl)(4-(phenylamino)naphthalen-1-yl)methylene)cyclohexa-2,5-dienylidene)-..(83803-79-6).The study assumed the use of male and female Wistar rats in subacute study of 28 days. No significant alterations were noted at the dose level of 589.33 mg/Kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for N-(4-((4-(dimethylamino)phenyl)(4-(phenylamino)naphthalen-1-yl)methylene)cyclohexa-2,5-dienylidene)-..(83803-79-6) is considered to be 462.0mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation.
Another Repeated dose toxicity study for structurally and functionally similar read across chemical was performed by OECD SIDS, SIAM 21 (Sub acute study for Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2- yl)amino]stilbene-2,2'-disulfonate, OECD SIDS, SIAM 21, October 2005) to determine the oral toxic nature of disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate(16090-02-1)to determine its toxic nature. The read across substances share high similarity in structure and log kow .Therefore, it is acceptable to derive information on mutation from the analogue substance. In a repeated dose toxicity studies for Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino] stilbene-2,2'-disulfonate in male and female rats for was evaluated for its toxic effect. The test substance was exposed at the concentration of 0, 51, 71 and 524 and 791 mg/kg bw/day for males and females, respectively for 28 days. The animals were observed for clinical sign, Hematology, clinical chemistry, organ weight and histopathology. As though a significant were observed on the kidney weight of dose level 524 and 791 mg/kg bw/day for males and females, respectively in treated group compare to control but no effect observed in the histopathology of kidney. No significant effects were observed at the clinical sign, Haematology, clinical chemistry and histopathology at all dose level. Therefore NOAEL was considered to be 524 and 791 mg/kg bw/day for males and females, respectively for Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino] stilbene-2,2'-disulfonate for 2 years study.
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 N-(4-((4-(dimethylamino)phenyl)(4-(phenylamino)naphthalen-1-yl)methylene)cyclohexa-2,5-dienylidene)-..(83803-79-6), which is reported as 5.76E-018Paat 25 deg C..Therefore this study is considered for waiver.
Repeated dermal study
The acute toxicity value for N-(4-((4-(dimethylamino)phenyl)(4-(phenylamino)naphthalen-1-yl)methylene)cyclohexa-2,5-dienylidene)-..(83803-79-6) (as provided in section 7.2.3) is > 2000 mg/kg bw/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 N-(4-((4-(dimethylamino)phenyl)(4-(phenylamino)naphthalen-1-yl)methylene)cyclohexa-2,5-dienylidene)-..shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that N-(4-((4-(dimethylamino)phenyl)(4-(phenylamino)naphthalen-1-yl)methylene)cyclohexa-2,5-dienylidene)-.shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.
Based on the data available for the target chemical and its prediction,N-(4-((4-(dimethylamino)phenyl)(4-(phenylamino)naphthalen-1-yl)methylene)cyclohexa-2,5-dienylidene)-..(83803-79-6) does not 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 target chemical and its read across, N-(4-((4-(dimethylamino)phenyl)(4-(phenylamino)naphthalen-1-yl) methylene)c yclohexa-2,5-dienylidene) -..(83803-79-6) does not 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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