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reaction mass of: trisodium 3-(5-(2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-(4-fluoro-6-morpholin-4-yl-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-naphthalenedisulfonate; trisodium 3-(5-(4,6-difluoropyrimidin-2-ylamino)-2-sulfonatophenylazo)-5-(4-fluoro-6-morpholin-4-yl-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-naphthalenedisulfonate
EC number: 436-890-6 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998-03-10 to 1998-04-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study was conducted when the LLNA has not already been the standard method for in vivo testing.
Test material
- Reference substance name:
- -
- EC Number:
- 436-890-6
- EC Name:
- -
- Molecular formula:
- C27H18F3N10Na3O11S3
- IUPAC Name:
- hexasodium 3-(2-{5-[(2,6-difluoropyrimidin-4-yl)amino]-2-sulfophenyl}diazen-1-yl)-5-{[4-fluoro-6-(morpholin-4-yl)-1,3,5-triazin-2-yl]amino}-4-hydroxynaphthalene-2,7-disulfonate 3-(2-{5-[(4,6-difluoropyrimidin-2-yl)amino]-2-sulfophenyl}diazen-1-yl)-5-{[4-fluoro-6-(morpholin-4-yl)-1,3,5-triazin-2-yl]amino}-4-hydroxynaphthalene-2,7-disulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- see below
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- Pirbright-White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: HARLAN WINKELMANN Gartenstr. 27 D-33178 Borchen SPF breeding colony
- Strain: HsdPoc:DH
- Weight at study initiation: mean 356g (n=15)
- Housing: fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet (e.g. ad libitum): ssniff Ms-H (V2233), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 degrees C
- Humidity (%): 50± 20%
- Photoperiod (hrs dark / hrs light): 12 hrs lighting time daily
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 5% / 2 * 0.1 mL in water
5% / 2 * 0.1 mL in 50% Freund Adjuvant - Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25% / 0.5 mL
- Day(s)/duration:
- Day 8 / 48 h
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25%
An amount of 0.5 ml of the test substance preparation was administered to a 2 x 2 cm cellulose patch. The administration area was then kept for 24 hours under an occlusive bandage with an impermeable film and an elastic bandage. - Day(s)/duration:
- Day 22 / 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Test Groups:
- Number of animals in test group: 10
- Number of animals in negative control group: 5
- Number of animals to determine the primary non-irritant concentration: 3
- Number of animals to determine the tolerance of the intradermal injections: 2
10 animals in the treatment group and 5 animals in the control group were used. In case of a questionable result additional animals will be tested to give a total of 20 test and 10 control animals. - Details on study design:
- RANGE FINDING TESTS:
- Determination of the primary non-irritant concentration:
Prior to the determination of the primary non-irritation concentration in a dermal occlusive test the animals received 4 intradermal injections of a 50% Freund's
Complete Adjuvant emulsion (4 x 0.1 ml) into the dorsal area. Two guinea pigs then received either 25%, 5%, or 1% test substance in dionized water. Flank hair was mechanically removed and 0.5 ml of the test substance preparation was administered to a 2 x 2 cm cellulose patch covered occlusive for 24 hours. 24 hours after removal of the patches, the treated skin areas were examined for erythema and edema.
- Determination of the tolerance of the intradermal injections:
To determine the tolerance of intradermal injections, 5%, 1%, or 0.2% of the test substance was administered twice by intradermal injection to 2 guinea pigs. 24, 48, 72 and 96 hours after administration the injection sites were examined for local tolerance.
MAIN STUDY
A1. INTRADERMAL INDUCTION EXPOSURE
- No. of exposures: 2 intradermal injections per animal
- Test groups: 5% test substance in dionized water or in 50% Freund's Adjuvant
- Control group: 50% Freund's Adjuvant
- Site: within a dorsal area of 2 x 4 cm
- Concentrations: 5% test substance
A2. DERMAL INDUCTION EXPOSURE
- Exposure period: 48 h
- Test groups: 25.0 % test substance in deionized water
- Control group: deionized water
- Site: The cellulose patch including the test substance covered the area where the intradermal injection had been placed
- Concentrations: 25.0 % test substance
B. CHALLENGE EXPOSURE
- Exposure period: 24h
- Test groups: 25.0 % test substance
- Site: One area of approx. 5 x 5 cm on the left flank, shaved mechanically
- Concentrations: 25.0 % test substance
- Evaluation (hr after challenge): 24h and 48h; visual skin reaction, fold thickness and histophathology after 48 h - Positive control substance(s):
- yes
- Remarks:
- benzocain
Results and discussion
- Positive control results:
- Benzocain caused sensitization by skin contact.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- body weight not impaired, no clinical signs of intoxication throughout study
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- based on skin fold measurement; see below
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- body weight not impaired, no clinical signs of intoxication throughout study
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- based on skin fold measurement; see below
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 25 %
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 25 %
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25 %
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Due to the red color of the test substance the treated skin of the animals could not be assessed for erythema 24 and 48 hours after removal of the occlusive bandage.
No significant difference in the fold thickness of the treated skin was detected between the animals of the control and of the treatment group.
In addition, no significant difference was found between the animals of the control and of the treatment group with respect to the histopathological evaluation of the treated skin area. The findings in both the control and the treatment group reveal a slight
reaction of the skin tissue indicating an irritant response to the occlusion of the skin.
Thus, neither measurement of the fold thickness nor histopathological examination of the treated skin showed any evidence for sensitizing properties of the test substance. No skin reactions were observed in the control group 24 and 48 hours after removal of the occlusive bandage.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Reactive Red FC73270 showed no evidence for sensitizing properties.
- Executive summary:
Testing for sensitizing properties of Reaktiv Rot FC-73270 was performed in female guinea pigs according to the method of MAGNUSSON & KLIGMAN. Intradermal induction was performed using 5 % Reaktiv Rot FC-73270 in deionized water. Dermal induction and challenge treatment were carried out with 25 % Reaktiv Rot FC-73270 in deionized water.
The validity of the test system is confirmed by the periodically conducted positive control test using benzocain for the maximization test.
Due to the red color of the test substance the treated skin of the animals could not be assessed for erythema. Based on both measurement of fold thickness and histopathological examination of the treated skin Reaktiv Rot FC-73270 showed no evidence for sensitizing properties.
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