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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
No relevant skin or eye irritating effects were seen in in-vivo studies in rabbits according to OECD 404 and 405, respectively.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Weight at study initiation: 2.3- 2.8 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet (e.g. ad libitum): ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water (e.g. ad libitum): water from automatic water dispensers, ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3degrees C
- Humidity (%): 50± 20%
- Photoperiod (hrs dark / hrs light): 12 hours daily of light - Type of coverage:
- semiocclusive
- Preparation of test site:
- abraded
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- -500 mg test substance was applied with 0.45 mL deionized water
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 30- 60 minutes, 24, 48 and 72 hours after removal of the patches
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 25 cm2
- Type of wrap if used: surgical plaster
REMOVAL OF TEST SUBSTANCE
- Washing (if done): substance were carefully removed from the skin with warm tap water
- Time after start of exposure: 4 h
SCORING SYSTEM:
- According to the score of DRAIZE - Irritation parameter:
- erythema score
- Basis:
- animal: 1, 2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Max. score:
- 4
- Remarks on result:
- not determinable
- Remarks:
- discolouration of skin did not allow a precise erythema analysis
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of corrosive effects
- Other effects:
- 30-60 min up to 24 h after removing the plaster very slight to well shaped erythem and oedema were found in the animals. The skin surface was discoloured pale blue up to 48 h. 72 h after removing the plaster all signs of skin irritations were reversible.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Slight erythema effects occurred in 2/3 animals but were fully reversible within 48 h. The substance is not classifiable according to CLP criteria.
- Executive summary:
In a primary dermal irritation study, 3 New Zealand albino rabbits obtained from Charles River Deutschland GmbH weighing 2.3-2.8 kg were dermally exposed to Reactive Navy FC63805 in deionized water to an area of 25 cm2 on the dorsal region of the body with hair removed with an electric clipper. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals were then observed for 3 days. Irritation was scored according to DRAIZE.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998-02-10 to 1998-02-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Weight at study initiation: 3.3- 3.7 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet (e.g. ad libitum): ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water (e.g. ad libitum): water from automatic water dispensers, ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3degrees C
- Humidity (%): 50± 20%
- Photoperiod (hrs dark / hrs light): 12 hours daily of light - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24h
- Observation period (in vivo):
- Eyes were examined 1, 24, 48 and 72 hours after administration
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- 24 hours after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37 degrees C.
SCORING SYSTEM:
-Cornea: degree of opacity (0-4), affected area (0-4)
- Iris (0-2)
- Conjunctivae: redness (0-3), chemosis (0-4), discharge (0-3)
- Additional information: S =slight, M =moderate, E =extreme, X = finding present, N = previous finding reversible, ? = not assessable - Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1, 3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of corrosivity observed. All very slight signs of irritation disappeared within 72 h.
- Other effects:
- Additionally a slight swelling of the conjunctiv and a clear substance coloured outflow was observed. 3 days p.a. the symptoms were reversible.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Reactive Navy FC63805 is classified as not irritating as a result from the eye irritation experiment in New Zealand albino rabbits according to CLP criteria.
- Executive summary:
In a primary eye irritation study according to OECD 405, 100 mg of Reactive Navy FC63805 was instilled into the conjunctival sac of the left eye of 3 New Zealand albino rabbits obtained from Charles River Deutschland GmbH weighing 3.3-3.7 kg for 24 hours. Treated eyes were washed with isotonic saline at approx. 37 degrees C 24 hours after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution took place. Animals were then observed for 3 days. Irritation was scored by the method described previously.
In this study, Reactive Navy FC63805 is not considered an eye irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a primary dermal irritation study, 3 New Zealand albino rabbits were dermally exposed to Reaktiv Marineblau FC 63805 in deionized water to an area of 25 cm² on the dorsal region of the body. Animals were then observed for 3 days. Irritation was scored according to DRAIZE. The mean score for erythema was 0.7 (max 3), and mean score for edema was 0 (max 0), therefore, Reaktiv Marineblau FC 63805 is slightly irritating to the skin.
In a primary eye irritation study, 100 mg of Reaktiv Marineblau FC 63805 was instilled into the conjunctival sac of the left eye of 3 New Zealand albino rabbits for 24 hours. Animals were then observed for 3 days. No effects on cornea or iris have been reported. The mean conjunctivae score was 0,44. The conjuctivae and chemosis maximum scores were 1 and 2, respectively. Scores for the iris and cornea were both 0. Therefore, results conclude Reaktiv Marineblau FC 63805 is not considered an eye irritant.
Justification for classification or non-classification
All signs of slight irritation were fully reversible in rabbit eyes and on rabbit skin. No positive indication of skin or eye irritation or any signs of corrosion were found. The substance is not classifiable according to CLP criteria.
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