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reaction mass of: tetrasodium 4-amino-6-(5-(2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(sulfatoethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate;tetrasodium 4-amino-6-(5-(4,6-difluoropyrimidin-2-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-sulfatoethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
EC number: 431-830-5 | 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
Endpoint summary
Administrative data
Description of key information
An acute oral and dermal toxicity study were performed according to OECD 401 (oral) and 402 (dermal) and GLP.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998-Jan-29 to 1998-Feb-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstr. 27, D-33178 Borchen
- Age at study initiation: 6-10 weeks
- Weight at study initiation: Male = 170 g; Female = 162 g
- Fasting period before study: from about 16 hours before to 3 - 4 hours after treatment
- Housing: in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet (e.g. ad libitum): ssniff RIM-H (V 1534), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least seven days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 50± 20 %
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: received the compound as a 20 % solution in deionized water
- Amount of vehicle (if gavage): 10 ml/kg body weight
DOSAGE PREPARATION (if unusual):
- Reaktiv Marineblau FC 63805 was dissolved in the stated concentration in deionized water and distributed homogeneously by means of a magnetic stirrer. - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5/sex
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed twice daily and once on weekends and public holidays; weighed once weekly
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: Blue discoloured faeces and diarrhea. Within 2 days all clinical symptoms were reversible.
- Gross pathology:
- No gross pathology changes.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of Reactive Navy FC 63805 in male and female rats is > 2000 mg/kg body weight.
- Executive summary:
In an acute oral toxicity study, groups of 6-10 weeks old Hsd:Sprague Dawley rats, 5/sex were given a single oral dose of Reactive Navy FC 63805 in deionized water at a dose of 2000 mg/kg body weight and observed for 14 days.
Oral LD50:
Male = >2000 mg/kg body weight
Female= >2000 mg/kg body weight
Combined = >2000 mg/kg body weight
Reactive Navy FC 63805 is of low toxicity based on the LD50 > 2000 mg/kg/d in both male and female Hsd:Sprague Dawley rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998-Feb-18 to 1998-Mar-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmlann, Gartenstrasse 27, 33178 Borchen
- Age at study initiation: 6-10 weeks
- Weight at study initiation: M=251g; F=203g
- Housing: in fully air-conditioned rooms in macrocolon cages (type III) on soft wood granulate, 1 animal per cage
- Diet (e.g. ad libitum): ssniff R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottels, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 50 ± 20%
- Photoperiod (hrs dark / hrs light):12 hours dark / 12 hours light - Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approximately 30 cm²
- Type of wrap if used: the test substance was moistened on an aluminum foil (6x8 cm) and distributed as uniformly as possible. The foil was held in place with an elastic plaster bandage fixed around the animal's body.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with warm water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g Reaktiv Marineblau FC 63805 was moistened with 0.45 ml deionized water
- Constant volume or concentration used: yes - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/ kg body weight
- No. of animals per sex per dose:
- 5/sex
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Symptoms were recorded twice every day (in the morning and in the afternoon), on weekend and public holidays only once.
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- Male: 2000 mg/kg body weight; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg body weight; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: No clinical signs
- Gross pathology:
- No gross pathology changes
- Other findings:
- - Other observations: The skin of the animals showed blue discolorations up to day 13 of the study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of Reactive Navy FC 63805 for male and female Sprague Dawley rats is >2000mg/kg body weight.
- Executive summary:
In an acute dermal toxicity study, HSD Sprague Dawley rats, 5/sex, were dermally exposed to Reactive Navy FC 63805 in deionized water for 24 hours to 30 cm² of body surface area at a dose of 2000 mg/kg body weight. Animals then were observed for 14 days.
Dermal LD50:
Males = >2000 mg/kg body weight
Females = >2000 mg/kg body weight
Combined = >2000 mg/kg body weight
Reactive Navy FC 63805 is of LOW Toxicity based on LD50 > 2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
In acute oral and dermal toxicity studies, groups of 5 Sprague Dawley rats per sex were exposed to a single dose of Reactive Navy FC 63805 at 2000 mg/kg body weight. Animals were then observed for 14 days. These experiments were limit tests; no mortalities were observed. For acute dermal toxicity no clinical signs were observed. A blue discoloration of the skin was visible for up to 13 days. For acute oral toxicity reversible blue colored feces and diarrhea were observed.
The oral and dermal LD50 are >2000 mg/kg body weight. Reactive Navy FC 63805 is of low acute toxicity.
Justification for selection of acute toxicity – oral endpoint
An acute oral study was performed according to OECD 401 following
GLP guidelines.
Justification for selection of acute toxicity – dermal endpoint
An acute dermal toxicity study was performed according to OECD 402
following GLP guidelines
Justification for classification or non-classification
No adverse effects were observed in an acute oral and dermal toxicity study, performed according to OECD 401 (oral) and 402 (dermal) GLP guidelines.
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