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EC number: 940-267-9 | CAS number: 1185314-63-9
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: read across from supporting substance
- Adequacy of study:
- key study
- Study period:
- 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The test has been performed following official guidelines, that completely assesses the end point, on a similar substance differing only by the counter ion potassium instead of sodium cation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-amino-6-[[4-[[[4-[(2,4-diaminophenyl)azo]phenyl]amino]sulphonyl]phenyl]azo]-5-hydroxy-3-[(4-nitrophenyl)azo]naphthalene-2,7-disulphonic acid, potassium salt
- EC Number:
- 286-384-2
- EC Name:
- 4-amino-6-[[4-[[[4-[(2,4-diaminophenyl)azo]phenyl]amino]sulphonyl]phenyl]azo]-5-hydroxy-3-[(4-nitrophenyl)azo]naphthalene-2,7-disulphonic acid, potassium salt
- IUPAC Name:
- 286-384-2
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- A total of 3 New Zeland White male rabbits were supplied by B&K Universal GJsl. On arrival at Centro de Investigacion Aplicado SAL the animals weighed 2.0-2.1 kg and were aged approxiamtely 9-10 weeks.
Before administration they were subjected to a prelimianry observation and acclimtization period of at least 7 days. At the start of the study the animals were in perfect health codnitions and weighed 2.2-2.3 kg.
Identification
The rabbits were individually identified using numbered ear tags. The number assigned to each rabbit was stated on the identification card on the cage.
Group size
The substance was tested on one group of three animals. The numbers assigned to the animals were 167, 184 and 195.
Housing
The rabbits were housed individually in stainless steel cages (48x59x37 cm) with a grille floor, placed on racks.
Each cage was identified by a card stating the study code number, administration route, animal number and sex, name or code of the test substance , animal delivery and administration date and study director's name..
Temperature in the animal room was maintained at 17-21°C. Relavtive humidity was between 45-70%.
Lighting was controlled to provide 12 hours light (7:00 to 19:00 hiours) and 12 hours dark per 24 hour period.
The animals were allowed free access to s standard rabbit diet UAR 112 which had been analysed by the manufacturer.
Water was supplied ad libitum by an automatic drinking system. The water, supplied by "Compania de Aguas de Sabadell SA" is periodically checked for the possble presence of contaminants.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: dampened with water
- Controls:
- other: the untreated skin areas of the test animal serve as the control
- Amount / concentration applied:
- 0.5g placed on a 2.5 x 2.5 cm squares of surgical gauze and applied to the corresponding test area
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- The reaction of the test zone was evaluated approximately 60 minutes, 24, 48 and 72 hours after the end if the exposure period.
- Number of animals:
- 3 male rabbits
- Details on study design:
- The animals were shaved approximately 24 hours before administration usign an electric razor, leaving the back and sides exposed from the scapula to the pelvis. One square test zone measuring approximately 6.2 cm squares was delimited on the shaved intatc skin of one side of the animals. The substance was placed on 2.5 x 2.5 cm squares of srugical gauze and applied to the patches in place. The resulting patches were held close to the body using strips of adhesive tape. Finally, a strip of gauze was fixed to the body using hypoallergenic adhesive tape to maintain the semi-occlòusive bandage in place. The aim of this semi-occlusive bandage was to allow good skin absorption of the test substance. Following administration, the animals were observed for a few moments before being returned to their cages. Four hours later, the bandage and patches were removed and the remains of the product were removed with distilled water.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 60 min
- Score:
- ca. 1
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 60min, 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 60 min
- Score:
- ca. 1
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 60 min
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 60min, 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 60min, 24h, 48h, 72h
- Score:
- 0
- Other effects:
- The behaviour and physical condition of the rabbits were normal throughout the study
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritant
- Conclusions:
- The substance was administered for the study of primary skin irritation in rabbits. After assessment of the alterations caused according to OECD 404 and EU B4, it is considered NON IRRITANT to the skin.
- Executive summary:
The degree of skin irritation caused by substance was determined after it was applied to shaved rabbit skin, under semi-occlusive patch and left for 4 hours. After assessment and evaluation of the alterations which it induced according to OECD 404 and EU B4 it is considered NON IRRITANT. In the examinations carried out in the first 60 minutes after removing the semi-occlusive patch, two animals presented very slight erythema (grade 1). In the examinations carried out 24, 48 and 72 hours after treatment, no dermal lesions were recorded in any of the animals. The mean erythem and edema scores for the substance at 24, 48 and 72 hours in the three animals, were both 0.
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