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EC number: 947-125-5 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 27th May 1997 to 3rd lune 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction products of diazotized 4'-Amino-4-Nitrodiphenylamine-2-Sulfonic Acid coupled with Resorcinol, sodium salts
- EC Number:
- 947-125-5
- Molecular formula:
- Not applicable for UVCB substance
- IUPAC Name:
- Reaction products of diazotized 4'-Amino-4-Nitrodiphenylamine-2-Sulfonic Acid coupled with Resorcinol, sodium salts
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: B & K UNIVERSAL G.J., S.L. (Sant Vincenç; dels Horts, Barcelona, Spain) on 12th May 1997 (no. 954, 958 and 972)
- Age at study initiation: 9-11 weeks.
- Weight at study initiation: 2.0-2.4 kg
- Housing: housed individually in stainless steel cages (48 x 59 x 37 cm), with a grille floor, placed on racks.
- Diet: The animals were allowed free access to a standard rabbit diet UAR 112
- Water: water was supplied ad libitum by an automatic drinking system.
- Acclimation period: 7 days.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Humidity: 40 - 75 %
- Photoperiod: 12 hours cycle dark/light (7:00 to 19:00)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- - Amount applied: 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- at 1, 24, 48, 72 hours and 7th day
- Number of animals:
- 3 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 6.2 cm^2
- % coverage: 2.5 x 2.5 cm^2
- Type of wrap if used: surgical gauze. The resulting patches were held close to the body using strips of adhesive tape. Finally, a strip of gauze was wrapped around the trunk of the animal in order to hold the patches in place. The gauze was fixed to the body using additional adhesive tape.
EVALUATION
The observations carried out were assessed according to the numerical scale and the degree of enythema and the formation of eschars and edema were quantified, as outlined in the OECD GUIDELINE FOR TESTING OF CHEMICALS, No. 404, of 17th July 1992.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Other effects:
- Clinical signs:
The behaviour and physical condition of the rabbits were normal throughout the Study.
Any other information on results incl. tables
Very slight, practically not noticeable, erythema (grade 1) was observed in all the animals as well as a yellow staining of the administered areas. Similarly, one ofthe animals was observed to present very slight edema (grade 1).
In the readings carried out at 24 -48 hours after removing the patches two of the animals continued to show very slight eiythema (grade 1) while the yellow staining of the administered areas was still observed in all the animals. At 72 hours, this presence of the yellow staining was still noted and only one animal continued to show very slight eiythema (grade 1). In the additional reading carried out 7 days post-treatment, the erythema had disappeared while the yellow staining remained in one ofthe animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC) no. 1272/2008
- Conclusions:
- The test item resulted not be irritating to the rabbit skin.
- Executive summary:
The degree of skin irritation caused by the substance was determined after its application to shaved rabbit skin, according to the OECD Guideline No. 404 (1992) and the method B.4 of the EEC Guidelines of 31st July 1992 (92/69/EEC). The substance was applied using a semi-occlusive patch, left for 4 hours.
The mean values (24/48/72 h) for edema scores were 0 in all animals; for erythema scores were 0.67, 1 and 0 in animals #1, #2 and #3 respectively. All the effects observed were fully reversible within the 7day-study period.
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