Registration Dossier
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EC number: 255-217-5 | CAS number: 41098-56-0
- 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:
- chronic toxicity: oral
- Remarks:
- combined repeated dose and carcinogenicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: comparable to guidelines/standards
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 4,4'-bis[4-[bis(2-hydroxyethyl)amino]-6-anilino-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonic acid
- EC Number:
- 224-548-7
- EC Name:
- 4,4'-bis[4-[bis(2-hydroxyethyl)amino]-6-anilino-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonic acid
- Cas Number:
- 4404-43-7
- IUPAC Name:
- 2,2'-ethene-1,2-diylbis[5-({4-anilino-6-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonic acid]
- Details on test material:
- - Analytical purity: 89.1%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar II
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 28 - 32 days
- Weight at study initiation: mean: males: 54 g, females: 53 g
- Fasting period before study:
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): once weekly
- Mixing appropriate amounts with (Type of food): Altromin R-Pulver feed (Altromin GmbH, Lage, Germany)
- Storage temperature of food: no data - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 24 months
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 1000, 10000 ppm
Basis:
nominal in diet
- No. of animals per sex per dose:
- 50
- Control animals:
- yes, plain diet
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly until 27th week, afterwards every 14 days
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: No
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
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
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: 1, 3, 6, 12 and 24 months after start of feeding study
- Anaesthetic used for blood collection: Yes (identity): ether
- Animals fasted: No data
- How many animals: 5 per sex and group, at the end 10 per sex and group
(number of erythrocytes, thrombocytes and leucocytes, reticulocytes, heamoglobin, haematocrit, MCH, MCV, thromboplastin time)
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: 1, 3, 6, 12 and 24 months after start of feeding study
- Animals fasted: No data
- How many animals: 5 per sex and group, at the end 10 per sex and group
(ALP, GOT, GPT, GlDH, creatinin, urea, blood glucose, cholesterin, bilirubin, protein)
URINALYSIS: Yes
- Time schedule for collection of urine: 1, 3, 6, 12 and 24 months after start of feeding study
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
(glucose, blood, protein, pH, keton, bilirubin, urobilinogen, sediment,)
NEUROBEHAVIOURAL EXAMINATION: No
OTHER FINDINGS: tumors - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
Organ weights: thyroid, heart, lung, liver, spleen, kidney, adrenal, testes, ovaries
HISTOPATHOLOGY: Yes
(aorta, eyes, duodenum, jejunum, ileum, colon), femur, brain, urin bladder, heart, testes, pituitary gland, liver, lung, lymph nodes, stomach, spleen, adrenals, kidney, epididymis, N. ischiadicus, oesophagus, parotid gland, ovaries, pancreas, prostata, seminal vesicle, thyroid, skeletal muscels, sternum, trachea, uterus, as well as all macroscopic changes). - Statistics:
- Mann-Whitney test, Wilcoxon test, Exact Fisher-test
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY were not affected by the test substance in all groups.
BODY WEIGHT AND WEIGHT GAIN: The body weight was transiently reduced in male animals at the dose of 10000 ppm
HAEMATOLOGY: The blood was not affected in all groups.
CLINICAL CHEMISTRY: No abnormal observations were detected.
URINALYSIS: No abnormal observations were detected.
ORGAN WEIGHTS: No abnormal observations were detected.
GROSS PATHOLOGY: No abnormal observations were detected.
HISTOPATHOLOGY: No abnormal observations were detected.
OTHER FINDINGS: Looking at type, localisation and frequency of found tumor there was no evidence of a cancerogenic activity of the test substance.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 10 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects, maximal tested dose
- Dose descriptor:
- NOAEL
- Effect level:
- 542 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: overall effects, maximal tested dose
- Dose descriptor:
- NOAEL
- Effect level:
- 779 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: overall effects, maximal tested dose
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 ppm
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: body weight at 10000ppm transiently reduced
- Dose descriptor:
- NOEL
- Effect level:
- 10 000 ppm
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: maximal tested dose; overall effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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