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EC number: 235-628-6 | CAS number: 12392-64-2
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- in vivo test. At the time of testing in-vitro test were not available
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study following official guidelines, GLP compliant, performed on a similar substance
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 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonato(3-)]chromate(3-)
- EC Number:
- 278-127-8
- EC Name:
- Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonato(3-)]chromate(3-)
- Molecular formula:
- C40H22CrN4O10S2.H.2Na
- IUPAC Name:
- Trisodium bis[(E)-3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonate]chromate(3-)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- The substance is the trisodium form of the target substance (disodium form)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Interfauna UK Ltd Wyton, Huntingdon, England- Age at study initiation: adult- Weight at study initiation: the animals were weighed immediately before application of the test substance- Housing: the rabbits were individually housed in stainless steel cages with flat rod bases or plastica cages with perforated bases, under standardised conventional conditions.- Diet (e.g. ad libitum): Standard diet "Ssniff K4" approx. 100-120g per animal/day; once a day in the morning- Water (e.g. ad libitum): tap water ad libitum- Acclimation period: prior to use the animals were acclimated for approx. one week in the animal room-Identification of the animals: the rabbits were identified by individual ear marks (tattoos) and cage cardsENVIRONMENTAL CONDITIONS- Temperature (°C): 21+/-1.5°C- Humidity (%): 60-80%- Air changes (per hr):12-15 times per hour- Photoperiod (hrs dark / hrs light):from 6 am to 6 pm, 12 hours artifical illumination
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: the controlateral skin area not treated with test substance served as control
- Amount / concentration applied:
- 500mg
- Duration of treatment / exposure:
- 4h
- Observation period:
- 1, 24, 48 and 72h, 7d, 14d
- Number of animals:
- 3
- Details on study design:
- Approx. 24hours before the test fur was shaved from the dorso-lateral area of the trunk (6x6 cm) of each of the rabbits. Care was taken to avoid abrading the skin. Only animals with healty and intact skin were used. 500 mg of the pulverised test substance were moistened with deionised water and subsequently applied to a hypoallergenic Hansamed patch. A further patch was moistened with water. The patches prepared in this way were placed in the opposite dorso-lateral areas of the trunk of each animal and were held in place with semiocclusive dressing for the duration of the exposure period. After the exposure time the dressing was removed and the exposed skin areas were carefully washed with water withou altering the existing response or the integrity of the epidermis.SCORING SYSTEM: for each animal the Draize scores recorded at 24, 48 and 72 h were added up. The total was divided by 3 to give the irritation index. This index was separately calculated for erythema/eschar formation and for oedema formation.TOOL USED TO ASSESS SCORE:fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: average 24,48 and 72h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: average 24,48 and 72h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: average 24,48 and 72h
- Score:
- ca. 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The substance was tested for skin irritation following OECD 404 and resulted not to have irritant potential to the skin.
- Executive summary:
The irritant/corrosive potential of the test substance was studied on the skin of rabbit in accordance with the OECD Guideline 404 for Testing of Chemicals.
Evaluation of erythema was not possible in all three animals due to the intense colouration by the test substance. Neverthless no other inflammatory signs (oedema or eschar formation) became apparent within the obervation period of 7 days. Signs of toxicity were not observed. This evidence indicates no hazard potential to the skin and the test substance may therefore be regarded as "not irritating" to the skin
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