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EC number: 220-028-9 | CAS number: 2610-11-9
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Existing study well reported and performed under GLP.
Test material
- Reference substance name:
- Disodium 7-benzamido-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate
- EC Number:
- 220-028-9
- EC Name:
- Disodium 7-benzamido-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate
- Cas Number:
- 2610-11-9
- Molecular formula:
- C29H21N5O8S2.2Na
- IUPAC Name:
- disodium 7-benzamido-4-hydroxy-3-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]naphthalene-2-sulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS- Source: BRL Biological Research laboratory Ltd- number of animals: 30 males / 6 females- Age at study initiation: 5 weeks- Weight at study initiation: Control and test group: 281-333 g Pretest:286-307 g- Housing: Individually in Makrolon type-3 cages with standard softwood bedding - Diet : Pelleted standard Kliba 342, Batch 63/91 guinea pig breeding/ maintenance diet, ad libitum.- Water: tap water , ad libitum. Once weekly additional supply of ascorbic acid (1 g/l) via the drinking water. - Acclimation period: One week under test conditions after veterinary examination.ENVIRONMENTAL CONDITIONS- Temperature (°C):22 ± 3°C- Humidity (%):40-70 % - Photoperiod : 12 hours artificial fluorescent light/12 hours dark, music/light period.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: for induction: physiological saline; for epidermal: vaselina album
- Concentration / amount:
- 5% for intradermal injenction5, 10, 15 and 25% for epidermal application The highest non-irritating test article concentration used for challenge application was 15%.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: for induction: physiological saline; for epidermal: vaselina album
- Concentration / amount:
- 5% for intradermal injenction5, 10, 15 and 25% for epidermal application The highest non-irritating test article concentration used for challenge application was 15%.
- No. of animals per dose:
- Main study induction: Control 10 females / Test Group: 20 femalesMain study challenge: Control 10 females / Test Group: 20 females
- Details on study design:
- MAIN STUDYA. INDUCTION EXPOSURE: injection- Test groups: 20 females- Control group: 10 females- Site: An area of dorsal skin from the scapular region (approximately 6 x 8 cm) was clipped free of hair. Three pairs of intradermal injections (0.1 ml/site) were made at the border of a 4 x 6 cm area in the clipped region- Concentrations: 5% with physiological saline, 5% by emulsion in a 50:50 mixture of Freund's colplete adjuvant and physiological salineINDUCTION EXPOSURE: epidermal application, one week after the injections- Exposure period: 48 h- Test groups: 20 females- Control group: 10 females- Site: (6 x 8 cm)- Type of coverage: filter paper was saturated with the test article and placed over the injection sites of the test animais. The patch was covered by aluminum foil and firmly secured by an elastic plaster wrapped around the trunk of the animal and secured with impervious adhesive tape.- Concentrations: 25 % in vaseline albumB. CHALLENGE EXPOSURE: The test and control guinea-pigs were challenged two weeks after the epidermal induction application.- Exposure period: approximately 24 hours later- Test groups: 20 females- Control group: 10 females- Site:hair was clipped and shaved from a 5 x 5 cm area on the left and right flank of each guinea-pig.- Type of coverage: Two patches (2 x 2 cm) of filter paper- Concentrations: 15% in vaseline album - Evaluation : 24, 48 hrsOTHER OBSERVATION:Mortality/Viability: dailyBody Weights:At acclimatization start, start of application and end of test.Symptoms (local systemic): dailyNecropsy: noAll animals were killed at the end of the test period with an intraperitoneal injection of pentobarbital (> 800 mg/kg) and discarded.
- Positive control substance(s):
- yes
- Remarks:
- Formaldheyde solution
Results and discussion
- Positive control results:
- 8 guinea pigs in a group of 10 animals showed positive response to the formaldehyde solution.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 28
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No systemic symptoms were observed.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 28.0. Group: test group. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No systemic symptoms were observed..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No systemic symptoms were obseved.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No systemic symptoms were obseved. .
- Reading:
- 1st reading
- Group:
- negative control
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to EEC (European Economie Community) and CLP classification criteria described in guidelines 83/467, September 16, 1983, the tested substance Direct Red 81 is not a sensitizer.
- Executive summary:
The purpose of this skin sensitization study was to assess the allergenic potential of Direct Red 81 when administered to the skin of albino guinea pigs following OECD 406, Maximization-Test of B. Magnusson and A.M. Kligman (1969).
Ten animals (10 females) were treated with the vehicle alone (vaseline album) and 20 animals (20 females) were treated with the test article.
Due to the unequivocal findings observed after the first challenge, no second challenge was performed.
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