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EC number: 267-097-1 | CAS number: 67786-25-8
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedures cannot be subsumed under a testing guideline, nevertheless they are well documented and scientifically acceptable.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
- Principles of method if other than guideline:
- A subchronic test of 13 weeks was performed in rats. Groups of 15 males and 15 females were administered by oral gavage with 30, 100 and 300 mg/kg bw/day of test substance in water emulsion (Cremophor).
- GLP compliance:
- no
- Remarks:
- pre GLP
- Limit test:
- no
Test material
- Reference substance name:
- Tetrasodium 4,4'-bis[[4-[bis(2-hydroxypropyl)amino]-6-[(4-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-stilbene-2,2'-disulphonate
- EC Number:
- 267-097-1
- EC Name:
- Tetrasodium 4,4'-bis[[4-[bis(2-hydroxypropyl)amino]-6-[(4-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-stilbene-2,2'-disulphonate
- Cas Number:
- 67786-25-8
- Molecular formula:
- C44H48N12Na4O16S4
- IUPAC Name:
- tetrasodium 2,2'-ethene-1,2-diylbis[5-({4-[bis(2-hydroxypropyl)amino]-6-[(4-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: males 114 and females 120 g.
- Housing: in groups of 5 in Macrolon cages (type 3).
- Diet: ad libitum, Altromin-R-Food.
- Water: ad libitum, tap water.
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2 °C.
- Photoperiod: from the 7.00 a.m. to 7.00 p.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- water emulsion (Cremophor).
- Duration of treatment / exposure:
- 91 days.
- Frequency of treatment:
- Daily.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
30, 100 and 300 mg/kg
Basis:
actual ingested
- No. of animals per sex per dose:
- 15 males and 15 females x dose x treated group.
30 males and 30 females in the control group. - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Control group dosed with 5.0 ml/kg of vehicle.
Examinations
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS
The animals were inspected daily.
BODY WEIGHT
The body weight was measured weekly.
HAEMATOLOGY
The following blood tests were performed in 5 rats pre dose after 13 weeks: hemoglobin as cyanmethemoglobin, counting the erythrocytes and leukocytes, platelet count, hematocrit determination, calculation of Färbe-coefficient, calculation of the corpuscular volume, assessment of complete blood count based on smears.
CLINICAL CHEMISTRY
In 5 rats of all groups, the following determinations were carried out after 13 weeks: activity of serum glutamate pyruvate Transeminase (GPT), serum glutamic-oxaloacetic transaminase, serum sorbitol dehydrogenase, glutamate dehydrogenase. In addition, the bilirubin concentrations were determined in serum.
In 5 rats of all groups, the concentration of urea and creatinine were determined after 13 weeks in the serum.
URINALYSIS
The urine were examined for albumin, sugar and blood; bile pigments: Ehrlich's reagent, Schlesinger's reagent; microscopic sediment analysis; specific gravity. - Sacrifice and pathology:
- After 13 weeks, the rats were anesthetized and killed by exsanguination.
The internal organs (thyroid, heart, Lungs, liver, spleen, kidneys, adrenals, testes and Ovarian) were macroscopically evaluated and weighed.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- no difference from the control group
- Mortality:
- no mortality observed
- Description (incidence):
- no difference from the control group
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- compatible with the control group
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- all values found were within the physiological range
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- no pathological findings
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- absolute and relative organ weights did not differ fron control
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- no changes were recorded
- Details on results:
- CLINICAL SIGNS AND MORTALITY
During the three month test period the rats of the treated groups did not differ from those of the control group.
BODY WEIGHT AND WEIGHT GAIN
The body weight increase in the treated groups was compatible with that recorded in the control group.
HAEMATOLOGY
All values found were within the physiological range.
CLINICAL CHEMISTRY
No indication of liver damage. For the kidney functionality evaluation, the values found were all in the normal range.
URINALYSIS
Also in the urine no pathological findings were observed.
ORGAN WEIGHTS
The average values of the absolute and relative organ weights of the groups of rats treated with the drug did not differ significantly from those of the control group.
GROSS PATHOLOGY
The internal organ macroscopically analysis showed no changes.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL ≥ 300 mg/kg bw/day (nominal).
- Executive summary:
Method
A subchronic test of 13 weeks was performed in rats. Groups of 15 males and 15 females were administered by oral gavage with 30, 100 and 300 mg/kg bw/day of test substance in water emulsion (Cremophor).
Results
During the three month test period the rats of the treated groups did not differ from those of the control group. The body weight increase in the treated groups was compatible with that recorded in the control group.
No treatment related findings were recorded in the hematological, clinical chemestry analysis and urinalysis. The internal organ macroscopically analysis showed no changes.
Conclusion
NOAEL ≥ 300 mg/kg bw/day (nominal).
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