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reaction mass of: pentasodium 4-amino-5-hydroxy-3-{(E)-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-6-{(E)-2-sulfonato-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}naphthalene-2,7-disulfonate;tetrasodium 4-amino-5-hydroxy-3-{(E)-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate;tetrasodium 4-amino-5-hydroxy-6-[(E)-2-sulfonato-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-3-[(E)-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate;trisodium 4-amino-5-hydroxy-3-[(2-hydroxyethylsulfonyl)-phenylazo]-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate;trisodium 4-amino-5-hydroxy-3-[(E)-4-(vinylsulfonyl)phenylazo]-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate;trisodium 4-amino-5-hydroxy-3-[(E)-4-(vinylsulfonyl)phenylazo]-6-[-2-sulfonato-4-(2-hydroxyethylsulfonyl)phenylazo]naphthalene-2,7-disulfonate
EC number: 445-280-9 | CAS number: 371921-40-3
- 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 April 08 to May 16, 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- April 29, 1993
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A Buehler test was already available and used for assessment
Test material
- Reference substance name:
- -
- EC Number:
- 445-280-9
- EC Name:
- -
- Cas Number:
- 371921-40-3
- Molecular formula:
- No molecular formula possible, it is a reaction mass.
- IUPAC Name:
- docosasodium 4-amino-3-[(1E)-2-[4-(ethenesulfonyl)phenyl]diazen-1-yl]-5-hydroxy-6-[(1E)-2-[4-(2-hydroxyethanesulfonyl)-2-sulfonatophenyl]diazen-1-yl]naphthalene-2,7-disulfonate 4-amino-3-[(1E)-2-[4-(ethenesulfonyl)phenyl]diazen-1-yl]-5-hydroxy-6-[(1E)-2-{2-sulfonato-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl]naphthalene-2,7-disulfonate 4-amino-5-hydroxy-6-[(1E)-2-{2-sulfonato-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl]-3-[(1E)-2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl]naphthalene-2,7-disulfonate 4-amino-6-[(1E)-2-[4-(ethenesulfonyl)-2-sulfonatophenyl]diazen-1-yl]-3-[(1E)-2-[4-(ethenesulfonyl)phenyl]diazen-1-yl]-5-hydroxynaphthalene-2,7-disulfonate 4-amino-6-[(1E)-2-[4-(ethenesulfonyl)-2-sulfonatophenyl]diazen-1-yl]-5-hydroxy-3-[(1E)-2-[2-(2-hydroxyethanesulfonyl)phenyl]diazen-1-yl]naphthalene-2,7-disulfonate 4-amino-6-[(1E)-2-[4-(ethenesulfonyl)-2-sulfonatophenyl]diazen-1-yl]-5-hydroxy-3-[(1E)-2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl]naphthalene-2,7-disulfonate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Himalayan spotted
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services CH-4414 Füllinsdorf / Switzerland
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 374 - 443 g; animals used for irritation screen: 401 - 416 g
- Housing: individually in Makrolon type-4 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418, batch nos. 02103 and 11/03, guinea pig breeding / maintenance diet, containing Vitamin C (Provimi Kliba AG, CH-4303 Kaiseraugst), ad libitum.
- Water (e.g. ad libitum): Community tap water from Füllinsdorf, ad libitum
- Acclimation period: One week for the control and test group. However, contrary to the test group the control group remained untreated during the 3 induction weeks. One day for the animals used in the irritation screen for induction and challenge. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG300
- Concentration / amount:
- 50 %
- Day(s)/duration:
- 3 weeks
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG300
- Concentration / amount:
- 50 %
- Day(s)/duration:
- 6 hours
- No. of animals per dose:
- 20 animals per dose group, 10 animals per control and 4 animals for irritation screen
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- Exposure period: 6 hours
- Test groups: only one test group at 50 % in PEG 300
- Control group: the control animals remained untreated
- Site: left shoulder
- Frequency of applications: one patch per week
- Duration: 3 weeks
- Concentrations: 50 % in PEG 300
B. CHALLENGE EXPOSURE
- Day(s) of challenge: day 29 after beginning of challenge (2 weeks after last application of induction)
- Exposure period: 6 hours
- Test groups: only one test group at 50 % in PEG 300
- Control group: treated with 50 % test item in PEG 300
- Site: left shoulder
- Concentrations: 50 % in PEG 300
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- Challenge control treated with the test item at 50 % in PEG 300
- Positive control substance(s):
- yes
- Remarks:
- ALPHA-HEXYLCINNAMALDEHYDE
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 % in PEG 300
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 % in PEG 300
- No. with + reactions:
- 15
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 5 % in PEG300
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 5 % in PEG300
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- treated with 50 % test item in PEG 300 at challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- treated with 50 % in PEG at challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 1B (indication of skin sensitising potential) based on CLP criteria
- Conclusions:
- Skin sensitizer
- Executive summary:
The purpose of this skin sensitizing study was to assess the possible allergenic potential of Navy MGi 1571 when administered topically to albino guinea pigs according to the OECD 406, "BühlerTest".
Twenty male animals of the test group were treated topically with Navy MGi 1571 at 50 % in pEG 300 once a week for a 3 week induction phase. Two weeks after the final induction application the animals were challenged with the same test item concentration of 50 % in PEG 300 as used for induction.
The ten animals of the control group were not treated during the induction. They were treated once at challenge with Navy MGi 1571 at 50 % in PEG 300.
Eleven (at the 24-hour reading) and fifteen (at the 48-hour reading) out of 20 test animals were observed with discrete/patchy to moderate/confluent erythema after the challenge treatment with the highest tested non-irritating concentration of Navy MGi 1571 at 50 % in PEG300.
No skin reactions were observed in the control group treated in the same conditions during the challenge phase.
Based on the above mentioned findings in a non-adjuvant sensitization test in guinea pigs Navy MGi 1571 applied at a
concentration of 50 % in PEG 300 was found to be as a skin sensitizer.
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