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Reaction mass of lithium sodium 5-amino-3-{[4-(2-{4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)diazenyl]-2-sulfophenyl}vinyl)-3-sulfophenyl]diazenyl}-4-hydroxynaphthalene-2,7-disulfonate 2,2'-(methylimino)diethanol (1:1) and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[6-amino-4-hydroxynaphthalene-2-sulphonic] acid, lithium sodium salt, compound with 2,2'-(methylimino)diethanol and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, lithium sodium salt, compound with 2,2'-(methylimino)diethanol
EC number: 916-916-7 | CAS number: -
- 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

Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study and GLP
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD TG 407
- GLP compliance:
- yes
- Type of method:
- in vivo
Test material
- Reference substance name:
- Reaction mass of lithium sodium 5-amino-3-{[4-(2-{4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)diazenyl]-2-sulfophenyl}vinyl)-3-sulfophenyl]diazenyl}-4-hydroxynaphthalene-2,7-disulfonate 2,2'-(methylimino)diethanol (1:1) and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[6-amino-4-hydroxynaphthalene-2-sulphonic] acid, lithium sodium salt, compound with 2,2'-(methylimino)diethanol and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, lithium sodium salt, compound with 2,2'-(methylimino)diethanol
- EC Number:
- 916-916-7
- Molecular formula:
- not available
- IUPAC Name:
- Reaction mass of lithium sodium 5-amino-3-{[4-(2-{4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)diazenyl]-2-sulfophenyl}vinyl)-3-sulfophenyl]diazenyl}-4-hydroxynaphthalene-2,7-disulfonate 2,2'-(methylimino)diethanol (1:1) and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[6-amino-4-hydroxynaphthalene-2-sulphonic] acid, lithium sodium salt, compound with 2,2'-(methylimino)diethanol and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, lithium sodium salt, compound with 2,2'-(methylimino)diethanol
- Test material form:
- other: liquid
- Details on test material:
- Dye content: 41.2 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 6-7 weeks
- Weight at study initiation (mean): males 193g , females 154 g
- Housing: in groups of 2 or 3 animals
- Diet ad libitum
- Water . ad libitum:
- Acclimation period: approximately 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Air changes (per hr): >10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- Bayscript Blaukomponente (konserviert) was adminestered orally by gavage to 5 male and 5 female Wistar rats per dose group using tap water as vehicle in daily doses of 0, 100, 300, 1000 mg/kg bw/day for aperiod of four weeks
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Before the start of the treatment the suitabilits of the proposed formulations was confirmed by the analyses of condentration and stabilits
Stability: the dosage forms prepared were analysed 4 hoursm 1,4,and 7 days after preparation
Concentration: the concenntration of samples of control and each tes substance dosage form prepared were determined twice during the study - Duration of treatment / exposure:
- males 28 days, females 29 days
- Frequency of treatment:
- once daily
- Duration of test:
- 30 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300, 1000 mg/kg bw/day
Basis:
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Bayscript Blaukomponente (konserviert) was adminestered orally by gavage to 5 male and 5 female Wistar rats per dose group using tap water as vehicle in daily doses of 0, 100, 300, 1000 mg/kg bw/day for aperiod of four weeks.The animals were regularely observed, weighed and food and water intakes were determined. O addition, clinical laboratory investigations of blood samples was performed. Organs and tissues wre subjected to gross and histopathological investigation.
- Statistics:
- Dunnett, U-test, Het-Dunn ( Dunnett exact test heterogeneous test)
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- other: NOAEL (general toxicity)
- Effect level:
- 300 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Dose descriptor:
- other: NOAEL (reproductive organs)
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: no relevant adverse effects observed
Observed effects
Treatment with Bayscript Blaukomponente resulted in several findings which were related to the color of the test substance. The whole body and several organs of animals treated with 1000 mg/kg bw/day appeared discolored. The kidneys were also discolored in the lower dose groups.
In the kidneys, beneath findings associated with the color of the test substance (starting at 300 mg/kg b.w./day), corticotubular degeneration and increased incidence and/or severity of cortical basophilic (regenerative) tubules were noted at 1000 mg/kg b.w./day. Furthermore, demyelinated fibers in nerve roots at the spinal cord were seen in both sexes at 1000 mg/kg b.w./day.
At 1000 mg/kg b.w./day, histopathological findings in the mesenteric lymph node, the interstitium of the testis, and in the Peyer's patch were related to the colored test item and not accompanied by other structural changes of the organs.
Minor changes in red blood cell parameters observed for males and females at 1000 mg/kg b.w./day were associated with appearing of golden-brown pigment deposition in the spleen in females. In males, the thrombocyte count was increased at 1000 mg/kg b.w./day.
Despite this general toxic effects no pathological changes were observed at the reproductive organs in amle and female rats
Under the conditions described the no adverse observed effect level (NOAEL) for administration of BAYSCRIPT Blaukomponente (konserviert) to male and female Wistar rats was 300 mg/kg b.w./day mainly due to degenerative effects on kidneys and nerve roots. With respect to reproductive organ toxitcity a NOAEL of 1000 mg/kgbw/day is established for male and female rats
Applicant's summary and conclusion
- Executive summary:
Bayscript Blaukomponente (konserviert) was administered orally by gavage to 5 male and 5 female Wistar rats per dose group using tap water as vehicle, in daily doses of 0, 100, 300, 1000 mg/kg bw/day for a period of four weeks. This GLP study was performed according to OECD guideline 407.
Treatment with Bayscript Blaukomponente resulted in several findings which were related to the color of the test substance. The whole body and several organs of animals treated with 1000 mg/kg bw/day appeared discolored. The kidneys were also discolored in the lower dose groups.
In the kidneys, beneath findings associated with the color of the test substance (starting at 300 mg/kg b.w./day), corticotubular degeneration and increased incidence and/or severity of cortical basophilic (regenerative) tubules were noted at 1000 mg/kg b.w./day. Furthermore, demyelinated fibers in nerve roots at the spinal cord were seen in both sexes at 1000 mg/kg b.w./day.
At 1000 mg/kg b.w./day, histopathological findings in the mesenteric lymph node, the interstitium of the testis, and in the Peyer's patch were related to the colored test item and not accompanied by other structural changes of the organs.
Minor changes in red blood cell parameters observed for males and females at 1000 mg/kg b.w./day were associated with appearing of golden-brown pigment deposition in the spleen in females. In males, the thrombocyte count was increased at 1000 mg/kg b.w./day.
Despite this general toxic effects no pathological changes were observed at the reproductive organs in amle and female rats
Under the conditions described the no adverse observed effect level (NOAEL) for administration of BAYSCRIPT Blaukomponente (konserviert) to male and female Wistar rats was 300 mg/kg b.w./day mainly due to degenerative effects on kidneys and nerve roots. With respect to reproductive organ toxitcity a NOAEL of 1000 mg/kgbw/day is established for male and female rats
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