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A mixture of: trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-(4-nitro-2-sulfonatoanilino)phenylazo)phenolato)ferrate(1-); trisodium bis(2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-nitro-2-sulfonatophenylazo)phenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(3-sulfonatophenylazo)phenolato)ferrate(1-); disodium 3,3'-(2,4-dihydroxy-1,3(or 1,5 or 3,5)-phenylenediazo)dibenzenesulfonate
EC number: 406-870-1 | CAS number: 115100-55-5
- 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:
- From February 14, 1990 to March 23, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1984
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study (different from LLNA test) is available.
Test material
- Reference substance name:
- A mixture of: trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-(4-nitro-2-sulfonatoanilino)phenylazo)phenolato)ferrate(1-); trisodium bis(2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-nitro-2-sulfonatophenylazo)phenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(3-sulfonatophenylazo)phenolato)ferrate(1-); disodium 3,3'-(2,4-dihydroxy-1,3(or 1,5 or 3,5)-phenylenediazo)dibenzenesulfonate
- EC Number:
- 406-870-1
- EC Name:
- A mixture of: trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-(4-nitro-2-sulfonatoanilino)phenylazo)phenolato)ferrate(1-); trisodium bis(2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-nitro-2-sulfonatophenylazo)phenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(3-sulfonatophenylazo)phenolato)ferrate(1-); disodium 3,3'-(2,4-dihydroxy-1,3(or 1,5 or 3,5)-phenylenediazo)dibenzenesulfonate
- Cas Number:
- 115100-55-5
- Molecular formula:
- not applicable
- IUPAC Name:
- triiron(3+) nonasodium 2-(2-{4-hydroxy-2-oxido-5-[2-(3-sulfophenyl)diazen-1-yl]phenyl}diazen-1-yl)-4,6-dinitrobenzen-1-olate 2-(2-{5-[2-(3,5-dinitro-2-oxidophenyl)diazen-1-yl]-2-hydroxy-4-oxidophenyl}diazen-1-yl)-4,6-dinitrobenzen-1-olate tris(2-(2-{5-[2-(3,5-dinitro-2-oxidophenyl)diazen-1-yl]-4-hydroxy-2-oxidophenyl}diazen-1-yl)-4,6-dinitrobenzen-1-olate) 2-{2-[4-hydroxy-5-(2-{4-[(4-nitro-2-sulfophenyl)amino]phenyl}diazen-1-yl)-2-oxidophenyl]diazen-1-yl}-4,6-dinitrobenzen-1-olate
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: ~ 11 weeks
- Weight at study initiation: 331 - 451 gram
- Housing: Group housing of 2 animals per cage with wire-mesh floors (ITL, Bergen, The Netherlands).
- Diet (e.g. ad libitum): Free access to standard guinea pig diet, including ascorbic acid (1600 mg/kg); LC 23-8, pellet diameter 4mm. (Hope Farms, Woerden, The Netherlands). In addition, once a week hay was provided (Broekman Institute, Someren, The Netherlands).
- Water (e.g. ad libitum): Free access to tap-water, diluted with decalcified water.
- Acclimation period: five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 5 °C
- Humidity (%): 40-70 %
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): Lighting was 12 hours artificial fluorescent light and 12 hours dark per day.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal:
A) The test substance dissolved to 5% (w/w) with physiological saline.
B) Freunds' Complete Adjuvant (FCA, Oifco, Detroit, U.S.A.)f 50:50 with distilled water for injection. (pyrogen free, Ferensius AG, Bad Homburg, FRG).
C) The test substance, at twice the concentration usad in (A), emulsified in a 50:50 mixture of Freunds' Complete Adjuvant.
Epidermal:
0.5 ml of the test substance (50 % (w/w) in milli-RO water) - Day(s)/duration:
- Intradermal injections: On day 1; Epicutaneous: Seven days after the intradermal injections,
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.05 ml of substance:
a = 25 % in milli-RO water.
b = 10 % in milli-RO water.
c = 5 % in milli-RO water.
d = milli-RO water. - Day(s)/duration:
- two weeks after the epidermal induction application/24 hours
- No. of animals per dose:
- RANGE FINDING TESTS:
Induction
1 per sex per dose
Challenge
4 per sex per doses
MAIN TEST:
Test groups:
20 per sex per dose
Control group:
10 per sex per dose - Details on study design:
- RANGE FINDING TESTS:
-INDUCTION EXPOSURE: intradermal
- No. of exposures: Four intradermal injections (0.1 ml/site)
- Test groups: 1 females guinea pigs
- Site: clipped shoulder region
- Frequency of applications: four injections
- Duration: single injection
- Concentrations:
Test group: 5 % (w/w) of the test substance in milli-RO water.
- Evaluation (hr after challenge): 24 and 48 hours later
The following parameters were recorded:
Erythema, Necrosis, Diameter:
-INDUCTION EXPOSURE: epicutaneous
-CHALLENGE EXPOSURE
- No. of exposures: one
- Exposure period: 24 hours.
- Test groups: 1 females guinea pigs
- Site: shaved left flank
- Concentrations:
Test group: 0.5 ml of a 50 % (w/w) concentration of the test substance in milli-RO water
- Evaluation (hr after challenge): 24 and 48 hours after removal of the dressings
-CHALLENGE EXPOSURE
- No. of exposures: one
- Exposure period: 24 hours.
- Test groups: 4 females guinea pigs
- Site: shaved left flank
- Concentrations:
Test group: 50 %, 25 %, 10 % and 5 % (w/w) test substance concentrations in milli-RO water (0.05 ml / concentration)
- Evaluation (hr after challenge): 24 and 48 hours after removal of the dressings
MAIN STUDY
A1. INDUCTION EXPOSURE: epicutaneous
- No. of exposures: Three pairs of intradermal injections (0.1 ml/site)
- Exposure period: day 1
- Test groups: 20 females guinea pig
- Control group: 10 females guinea pig
- Site: shaved left flank 4 X 6 cm
- Frequency of applications:
- Duration:
- Concentrations:
Test group:
A)5% (w/w) with physiological saline
B)Freunds' Complete Adjuvant (FCA, Oifco, Detroit, U.S.A.)f 50:50 with distilled water for injection. (pyrogen free, Ferensius AG, Bad Homburg, FRG).
C)The test substance, at twice the concentration usad in (A), emulsified in a 50:50 mixture of Freunds' Complete Adjuvant.
A2. INDUCTION EXPOSURE: epidermal
- No. of exposures: one
- Day(s) of challenge: Seven days after the intradermal injections
- Exposure period: 48 hours
- Test groups: 20 females guinea pig
- Control group: 10 females guinea pig
- Site: the scapular area (approximately 6 X 8 cm) was again clipped and shaved free of hair.
- Concentrations: A 2 x 4 cm patch of Metalline mounted on Micropore tape was treated with 0.5 ml of the test substance (50 % (w/w) in milli-RO water), the control group only with vehicle.
- Evaluation (hr after challenge): Reaction sites were assessed for erythema and oedema immediately after removal of the dressings.
B. CHALLENGE EXPOSURE
- No. of exposures: 4
- Day(s) of challenge: two weeks after the epidermal induction application.
- Exposure period: after approximately 24 hours.
- Test groups: 20 females guinea pig
- Control group: 10 females guinea pig
- Site: 5 x 5 cm area on the left flank
- Concentrations: A volume of 0.05 ml of each concentration
a = 25 % in railli-RO water.
b = 10 % in milli-RO water.
c = 5 % in milli-RO water.
d = milli-RO water. - Positive control substance(s):
- yes
- Remarks:
- FORMALDEHYDE
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.25 %
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1 %
- No. with + reactions:
- 3
- Total no. in group:
- 20
Any other information on results incl. tables
SIGNS OF TOXICITY
No signs of systemic toxicity were observed during the primary irritation experiments, with exception of body weight loss in three of the five animals.
The choice of milli-RO water as vehicle in this test was based on the following:
- the test article dissolved\suspended well in milli-RO water.
- the test article is stable in milli-RO water.
In accordance with Magnusson and Kligman (1969) and based on the findings in the primary irritation experiments, the following concentrations were selected for the induction and challenge phase:
Intracutaneous induction: 5 % (w/w) in milli-RO water.
Epicutaneous induction: 50 % (w/w) in milli-RO water.
Challenge:
a = 25 % (w/w) in milli-RO water.
b = 10 % (w/w) in milli-RO water.
c = 5 % (w/w) in milli-RO water.
d = milli-RO water.
INDUCTION
Three experimental animals showed skin irritation after the 48 hours occluded epicutaneous induction exposure
CHALLENGE
CONTROL GROUP:
No positive skin reactions were evident after the challenge exposure
EXPERIMENTAL GROUP:
Four animals showed a positive reaction in response to the 25% concentration.
Thirteen other animals showed red spots with or without scaliness in response to one, two or three of the concentrations tested
TOXICITY SYMPTOMS / MORTALITY
No symptoms of systemic toxicity were observed in the animals during the study.
No mortality occurred during the study.
BOOY WEIGHTS
The average body weight gain of experimental and control animals was similar.
Applicant's summary and conclusion
- Interpretation of results:
- other: classified as Skin Sens. 1B according to the CLP regulation (EC) no. 1272/2008
- Conclusions:
- The test article at concentration of 25 % in water is considered to be a skin sensitizer when described under the test conditions.
- Executive summary:
A GPMT was performed in order to obtain information on the potential of the test substance to induce delayed contact hypersensitivity (skin sensitisation) in the guinea pig, according to OECD guideline 406 (1981).
The intracutaneous route of administration (first induction at 5 %) was selected in order to obtain optimal contact between the test substance and elements of the immunosystem. Freunds Complete Adjuvant (FCA) was added to attract circulating immunocompetent cells to the injected area. The dermal route of administration (second induction and challenge) was performed. The test and control guinea pigs were challenged two weeks after the epidermal induction application. The dressings and residual test substance were removed after approximately 24 hours. The sites were assessed for redness and sweiling 24 and 48 hours after removal of the dressings. A positive control was tested in a concurrent study in order to verify the test validity. The following results were obtained:
POSITIVE SKIN REACTIONS TO THE CHALLENGE
Test Substance Concentration 25% 10% 5% 0% EXPERIMENTAL GROUP
Number of animals with positive reaction4 0 0 0 Sensitisation rate 20 0 0 0 CONTROL GROUP
Number of animals with positive reaction0 0 0 0
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