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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Reference
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.

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