[4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate

Repeated dose toxicity: oral

Administrative data

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.

Data source

Reference

Reference Type:

secondary source

Title:

Sub acute study for Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2- yl)amino]stilbene-2,2'-disulfonate

Author:

OECD SIDS, SIAM 21

Year:

2005

Bibliographic source:

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

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate

EC Number:

240-245-2

EC Name:

Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate

Cas Number:

16090-02-1

Molecular formula:

C40H40N12O8S2.2Na

IUPAC Name:

disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate

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

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

Not specified

Administration / exposure

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

Doses / concentrations

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

Examinations

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

Results and discussion

Results of examinations

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

Effect levels

1

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

2

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

Target system / organ toxicity

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

Applicant's summary and conclusion

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.