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Reaction mass of disodium 4-amino-6-[[4-[(2,4-diaminophenyl)diazenyl]phenyl]]-3-((E)-[4-((E)-(2,4-diaminophenyl)diazenyl]phenyl )diazenyl)-5-hydroxynaphthalene-2,7-disulphonate and disodium 4-amino-6-((E)-(4-aminophenyl)diazenyl)-3-((E)-(4-((E)-(2,4-diaminophenyl)diazenyl)phenyl)diazenyl)-5-hydroxynaphthalene-2,7-disulfonate
EC number: 951-695-0 | 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: experimental study on similar substance
- Adequacy of study:
- key study
- Study period:
- March 9,1994 - May 20,1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, test procedure in accordance with OECD 406 methods, meets generally accepted scientific principles, acceptable for assessment. Not GLP compliant.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was performed before the validation of LLNA OECD method and is considered to be valid and acceptable for the assessment.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Company distributed by Anlab s.r.o. Praha
- Weight at study initiation: 390-472 g
- Housing: Guinea pigs were housed in separate plastic cages type T4.
- Diet : Experimental animals were fed with a standard granulated feed mixture with a composition which provided full biological and nutritional diet for experimental animals. The mixture contains oats, barley, soy flour extracted, protein, wheat bran, sodium chloride etc.
- Water: guinea pigs were supplied with safe drinking water, according to CSN 757111 and each animal additionaly received 20 mg of ascorbic acid per day.
- Acclimation period: at least 5 days
Regular cleaning and disinfection of cages was performed to prevent contamination of pathogens according to standard operating
procedure.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22° C ± 3°C
- Humidity (%): 50% ± 15%
- Photoperiod: 12-hour light cycle - Route:
- intradermal and epicutaneous
- Vehicle:
- other: water for injections and vaseline alba for topic application
- Concentration / amount:
- For injections: 0,5 % of the tested substance in water solution
For topic application: 25 % for tested substance in vaseline alba - Route:
- epicutaneous, occlusive
- Vehicle:
- other: water for injections and vaseline alba for topic application
- Concentration / amount:
- For injections: 0,5 % of the tested substance in water solution
For topic application: 25 % for tested substance in vaseline alba - No. of animals per dose:
- Experimental group: 20 females x dose
Control group: 10 females x dose - Details on study design:
- A. INDUCTION: INTRADERMAL INJECTION
Day 0- treated group:
Three paires of intradermal injections of 0,1 ml volume were applied to the shaved area:
injection 1: a 1:1 mixture Freunds Complete Adjuvant (FCA)/water
injection 2: 0,5 % of the test substance in water solution
injection 3: 0,5 % of the test substance in water solution formulated in a 1:1 mixture FCA/water
Day 0- control group:
Three paires of intradermal injections of 0,1 ml volume were applied to the shaved area.
injection 1: a 1:1 mixture FCA/water
injection 2: water for injection
injection 3: a 50 % w/v formulation of the vehicle in a 1:1 mixture (v/v) FCA/water
INDUCTION: TOPICAL APPLICATION
Day 7- treated group:
Tested area was again shaved. On the identical site of intradermal injection was applied a filter paper (2x4cm)
which was loaded with 10% of tested substance in white vaseline and held in contact by an occlusive dressing for 48 hours.
The gauze pad was kept in contact with the skin by an adhesive hypoallergenic patch under an occlusive aluminum foil sheet of 5x5 cm.
Day 7- control group:
Tested area was again shaved. White vaseline was applied to an identical area of intradermal injection on filter
paper (2x4 cm) in occlusive dressing for 48 hours. The gauze pad was kept in contact with the skin by an adhesive hypoalle
rgenic patch under an occlusive aluminum foil sheet of 5x5 cm.
B. CHALLENGE: TOPICAL APPLICATION
Day 21- treated and control group:
On the right side of the animals was applied a filter paper (2x2 cm) impregnated with 0.5% solution of the tested substan ce in water for injections, occlusive dressing covered a period of 24hrs.
After 1,24,48 and 72 hours was removed the patch and the challenge area was cleaned with water and was carried out cl inical trials, focusing on the intensity of erythema and edema. - Reading:
- 1st reading
- Hours after challenge:
- 1
- Group:
- test chemical
- Dose level:
- 0,5 % of the tested substance in water
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- Edema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 1.0. Group: test group. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: Edema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0,5 % of the tested substance in water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0,5 % of the tested substance in water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0,5 % of the tested substance in water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 1
- Group:
- negative control
- Dose level:
- 0,5 % of the tested substance in water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 1.0. Group: negative control. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0,5 % of the tested substance in water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0,5 % of the tested substance in water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0,5 % of the tested substance in water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 1
- Group:
- test chemical
- Dose level:
- 0,5 % of the tested substance in water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 1.0. Group: test group. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0,5 % of the tested substance in water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0,5 % of the tested substance in water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0,5 % of the tested substance in water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 1
- Group:
- negative control
- Dose level:
- 0,5 % of the tested substance in water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 1.0. Group: negative control. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0,5 % of the tested substance in water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0,5 % of the tested substance in water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0,5 % of the tested substance in water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0,5 % of the tested substance in water. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: all
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No positive skin reaction was observed in the experiment.
- Executive summary:
- Skin was exposed to maximal concentration of the tested substance.The number of sensitized animals determine the potency of contact allergens. No positive skin reaction was observed in the first or in repeated experiments and it can be concluded that the tested substance is not an allergenThere were no differences in growth and development of animals between experimental and control group. The tested substance is not an allergen.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A guinea pig maximisation test is available for Direct Black 19 following official guidelines of OECD 406.
The result shows no sensitising effects after 1, 24, 48 and 72 hours.
Migrated from Short description of key information:
Not sensitising
Justification for selection of skin sensitisation endpoint:
Study well documented, test procedure in accordance with OECD 406 methods, meets generally accepted scientific principles, acceptable for assessment. Not GLP compliant.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
Migrated from Short description of key information:
No data
Justification for classification or non-classification
No classification for sensitisation is warrented under Regulation CE 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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