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Reaction mass of tetrasodium 3-[[4-[[4-[(6-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]-6-sulphonato-1-naphthyl]azo]-1-naphthyl]azo]naphthalene-1,5-disulphonate and tetrasodium 3-[[4-[[4-[(6-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]-7-sulphonato-1-naphthyl]azo]-1-naphthyl]azo]naphthalene-1,5-disulphonate
EC number: 911-640-3 | 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Since March 9,1994 - May 20,1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- not GLP compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- 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.
Test material
- Reference substance name:
- tetrasodium 6-[(1E)-2-{4-[(1E)-2-{4-[(1E)-2-(6-amino-1-hydroxy-3-sulfonatonaphthalen-2-yl)diazen-1-yl]-7-sulfonatonaphthalen-1-yl}diazen-1-yl]naphthalen-1-yl}diazen-1-yl]naphthalene-1,4-disulfonate
- EC Number:
- 911-640-3
- Molecular formula:
- C40H27N7O13S4.4Na
- IUPAC Name:
- tetrasodium 6-[(1E)-2-{4-[(1E)-2-{4-[(1E)-2-(6-amino-1-hydroxy-3-sulfonatonaphthalen-2-yl)diazen-1-yl]-7-sulfonatonaphthalen-1-yl}diazen-1-yl]naphthalen-1-yl}diazen-1-yl]naphthalene-1,4-disulfonate
- Details on test material:
- SMILE notation for Vapour pressure
O=S(=O)(O[Na])c8cccc1c8cc(cc1S(=O)(=O)O[Na])/N=N/c7ccc(/N=N/c5ccc(/N=N/c2c(O)c3ccc(N)cc3cc2S(=O)(=O)O[Na])c4cc(ccc45)S(=O)(=O)O[Na])c6ccccc67
Constituent 1
In vivo test system
Test animals
- 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.
- Weight at study initiation: 302-364 g
- Housing: Guinea pigs were housed in separate cages in plastic cages type T4. The group of 5 animals were housed in one cage.
- Diet : Experimantal animals were fed with a standard granulated feed mixture TM produced commercially in Kocanda. Animals were fed ad libitum. Raw material composition provided full biological and nutritional diet for experimental animals
- Water: guinea pigs were supplied with safe drinking water, according to CSN 757111 and ogni animal additionaly received 20 mg of sorbic acid per day.
- Acclimation period: at least 1 week
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
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 0,5 % of the tested substance in water solution
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0,5 % of the tested substance in water solution
- No. of animals per dose:
- Exterimental group: 20 females x dose (0,5% )
Control group: 10 females x dose - Details on study design:
- A. INDUCTION: INTRADERMAL INJECTION
Day 0- treated group:
Three pairs of intradermal injections of 0,1 ml volume were applied to the shaved area .
injection 1: a 1:1 mixture 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 pairs 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 on the neck was again shaved. On the identical site of intradermal injection was applied a filter paper (2x4cm) which was loaded with 25% of tested substance in white vaseline and held in contact by an occlusive dressing for 48 hours.
Day 7- control group:
Tested area on the neck 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.
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 substance in water for injections, occlusive dressing covered a period of 24hrs. Skin reaction were evaluted on 1, 24, 48 and 72 hours after removal of the patch and cleaning of the challenge area with water. Clinical trials were performed, focusing on the intensity of erythema and edema .
Day 28- treated and control group
second exposure is recommended to avoid false negative results. On the left side of animals was applied a filter paper (2x2 cm) impregnated with 0.5% solution of the tested substance 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 a evaluation of the skin reactions.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 1
- Group:
- test chemical
- Dose level:
- 0,5 % of the tested substance in water
- No. with + reactions:
- 4
- Total no. in group:
- 20
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Reading:
- other: all
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified under Regulation 1272/2008
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance was tested following OECD 406 for skin sensitisation. No positive skin reactions were observed in the first or in repeated experiments.
- Executive summary:
- The substance was tested following OECD 406 for skin sensitisation (GMPT). The skin was exposed to maximal concentration of the tested substance and the allergenic potential was determined using the known factors for confirmed contact allergy, such as penetration, skin irritation, and high concentrations.
Induction was performed by intradermal and topical application. Clinical sign (edhema and erythema) were evaluated and no animal showed any important skin reactions after 1, 24, 48 and 72h and it can be concluded that the substance has no allergenic potential.
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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