Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 26th May 1997 to 9th June 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 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues 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: 9-10 weeks.
- Weight at study initiation: 2.1-2.6 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: 18 - 23 °C
- Humidity: 40 - 85 %
- Photoperiod: 12 hours cycle dark/light (7:00 to 19:00)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- - Amount applied: 100 mg
- Observation period (in vivo):
- at 1, 24, 48 and 72 hours and 7, 14 days
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: yes, washing the area with a 0.9% physiological saline solution.
ASSESSMENT OF EYE INJURIES
The ocular reactions observed in the cornea, iris and conjunctivae were assessed according to the classification, as outlined in the OECD GUIDELINE FOR TESTING OF CHEMICALS, No. 405, of 24th February 1997
TOOL USED TO ASSESS SCORE: 2% aqueous sodium fluorescein solution
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: rinsed eye
- Irritation parameter:
- iris score
- Basis:
- animal: #1, 2#, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: rinsed eye
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: #1, 2#, #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Reversibility:
- fully reversible within: 7 d (#2) and 14 d (#1, #3)
- Remarks on result:
- other: rinsed eye
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: rinsed eye
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: rinsed eye
- Other effects:
- Clinical signs:
the behaviour and physical condition of the rabbits were normal throughout the study.
Any other information on results incl. tables
In the course of the first hour after administration, the test substance induced in the palpebral and bulbar conjunctivae of all the animals, diffuse crimson redness with individual vessels difficult to discern (grade 2) accompanied by swelling with lids nearly or completely closed (grade 4) in two animals and swelling with lids approximately half closed (grade 3) in the remaining animal. All the animals also presented lacrimation, with wetness of the eyelids and nearby hair in one animal and wetness ofthe eyelids and nearby hair, affecting a considerable area in the remaining animals.
One of the animals presented corneal opacity (grade 1). In the readings performed at 24 hours from treatment, all the animals presented diffiuse crimson redness in the conjuncttvae with individual vessels difficult to discern (grade 2) accompanied by some above-normal swelling (grade 1) in one ofthe animals. In the observations perforned at 2 and 3 days from treatment all the animals presented some clearly hyperaemic blood vessels (injected) (grade 1). In the reading made after 7 days, two of the three animals continued to show some clearly hyperaemic blood vessels (injected) (grade 1). In the observations performed 14 days after treatment, the said alterations had totally disappeared.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC) no. 1272/2008
- Conclusions:
- The substance was found not to be irritant to the rabbit eye.
- Executive summary:
The test substance was tested in order to evaluate the primary eye irritation, according to the OECD Guideline No. 405 (1987) and to the method B.5 of the EEC Directive of 31st July 1992 (92/69/EEC).
The mean values (24/48/72 h) for corneal opacity and iris scores were 0 in all animals; for conjunctivae redness were 1.33 all animals. The mean scores for conjunctivae edema were 0.33 in one animal (#1) and 0 the other two animals (#2 and #3). In the observations performed at 14 days after treatment, the said alterations were observed to be reversible.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.