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EC number: 609-336-8 | CAS number: 371756-75-1
- 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
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
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:
- 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
- IUPAC Name:
- disodium 2,2'-ethene-1,2-diylbis{5-[(4-anilino-6-morpholin-4-yl-1,3,5-triazin-2-yl)amino]benzenesulfonate}
- Details on test material:
- - Analytical purity: 92%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: 28 to 32 days
- Weight at study initiation: males: 53 g; females: 54 g (mean)
- Diet: Altromin R-Pulverfutter ( Altromin GmbH, Lage), ad libitum
- Water: tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23±3 °C
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 24 months
- Frequency of treatment:
- continously in food
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: No data
BODY WEIGHT: Yes
- Time schedule for examinations: weekly until study week 27 and every second week thereafter
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: after 1, 3, 6, 12 and 24 month.
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: 5 male and 5 female rats after 1, 3, 6 and 12 month and from 10 male and 10 female rats after 24 month.
- Parameters examined: Erythrocyte count, Hemoglobin, Leukocyte count, Reticulocyte count, Thrombocyte count, differential counts, Hematocrit
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: after 1, 3, 6, 12 and 24 month.
- Animals fasted: No data
- How many animals: 5 male and 5 female rats after 1, 3, 6 and 12 month and from 10 male and 10 female rats after 24 month.
- Parameters examined: Alkaline Phosphatase, Total Protein, Albumin, Glucose, Urea, Creatinine, Bilirubin, total Cholesterol, Aspartate aminotransferase, Alanine aminotransferase,
URINALYSIS: Yes
- Time schedule for collection of urine: after 1, 3, 6, 12 and 24 month.
- Metabolism cages used for collection of urine: Yes
- Animals fasted: No data
- Parameters examined: Glucose, Blood, total Protein, pH, Bilirubin, Urobilirubin, Sedime
NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, necropsies were performed on all animals
HISTOPATHOLOGY: Yes, adrenals, aorta, brain, epididymides, eyes, femur, heart, ichiatic nerve, intestine, kidneys, liver, lung, lymph nodes, muscle, esophagus, ovaries, pancreas, pituitary gland, prostate seminal vesicle, salivary gland, spleen, sternum, stomach, testes, trachea, thyroids, urinary bladder, uterus, as well as all gross pathological lesion were sampled and subjected to histopathological examination. - Other examinations:
- The organ weights of adrenals, heart, kidneys, liver, lung, ovaries, spleen, testes and thyroid gland were recorded
- Statistics:
- Mann-Whitney and Wilcoxon test
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Treatment with FWA-1 did not affect mortality, appearance or behavior of treated animals.
BODY WEIGHT AND WEIGHT GAIN
Body weight development of treated animals were similar to those of the control group.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
Food consumption of treated animals were similar to those of the control group.
HAEMATOLOGY
The assessment of hematological data did not indicate any adverse effects in treated animals. The significantly and dose dependently increased number of thrombocytes in female rats after one month in all dose groups, was not considered adverse because there was no confirmation of these findings in the further course of the study and all values were within historical control ranges of this Wistar rat strain. The not dose-dependent but statistically significant decrease in the number of reticulocytes in males after 3 months was also considered not to be toxicologically relevant because of the same reasons
CLINICAL CHEMISTRY
The assessment of clinical biochemical data did not indicate treatment related disturbances. Slightly and not dose-dependently but statistically significant increased ALAT (GPT) activities were observed in males after 24 months at the end of the study in all dose groups. Slightly and not dose-dependently but statistically significant increased protein concentrations in blood serum were observed after 6 months in both sexes and all dose groups as well as after 24 months in males in all dose groups. These effects on ALAT and serum protein were considered not to be toxicologically relevant, but due to relative low control values as compared with normal historical data in this Wistar rat strain.
URINALYSIS
The assessment or urine analysis data did not indicate treatment related disturbances.
ORGAN WEIGHTS
Treatment at 10000 ppm slightly increased absolute liver and kidney weights in males to 111% and 106% of control, respectively. Absolute ovary weights were increased to 127% of control at 10000 ppm. The increased organ weights were considered not to be toxicologically relevant by the study authors, because there were no accompanying hematological, biochemical or histopathological changes.
GROSS PATHOLOGY
A number of benign and malignant neoplasms, including thyroid interstitial cell neoplasia, pituitary neoplasia, endometrial neoplasia, phaeochromocytoma, and testicular interstitial cell neoplasia, were noted in all dose groups including controls. However, statistical analysis of tumor incidences revealed no significant differences between control and treated groups. In addition, the tumor incidences were not organ or neoplastic class specific and therefore were regarded not to be biologically significant.
HISTOPATHOLOGY: NON-NEOPLASTIC
Histopathological investigations revealed no evidence for treatment related changes.
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, highest dose tested
- Dose descriptor:
- NOAEL
- Effect level:
- 523.9 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: overall effects, highest dose tested
- Dose descriptor:
- NOAEL
- Effect level:
- 790.6 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: overall effects, hightest dose tested
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Based on the outcomes of this 'Combined Oral Chronic Toxicity/Carcinogenicity' study in Wistar rats, FWA-1 is considered not to be toxic at dietary levels upt to 10000 ppm, corresponding with 524 mg/kg bw/day for males and with 791 mg/kg bw/day for females.
Applicant's summary and conclusion
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