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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 269-944-0 | CAS number: 68391-32-2
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 July 2004 - 19 July 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: EC Commission Directive 92/69/EEC, B.5, "Acute Eye Irritation/Corrosion" (1992)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF guidelines (2000).
- Principles of method if other than guideline:
- The purpose of this acute eye irritation/corrosion study was to assess the possible irritation or corrosion potential when a single dose of the test substance was placed in the conjunctival sac of the rabbit eye.
The absence of eye pigmentation in the albino rabbit facilitates the evaluation of induced eye reactions. The ocular route was selected because the test substance may accidentally come into contact with the eyes during manufacture, handling and/or use. - GLP compliance:
- yes
Test material
- Reference substance name:
- [8-[(4-amino-3-nitrophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride
- EC Number:
- 269-944-0
- EC Name:
- [8-[(4-amino-3-nitrophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride
- Cas Number:
- 68391-32-2
- Molecular formula:
- ClN5O3
- IUPAC Name:
- 8-[(4-amino-3-nitrophenyl)diazenyl]-7-hydroxy-N,N,N-trimethylnaphthalen-2-aminium chloride
- Reference substance name:
- (8-((4-Amino-3-nitrophenyl)azo)-7-hydroxy-2-naphthyl)trimethylammonium chloride
- IUPAC Name:
- (8-((4-Amino-3-nitrophenyl)azo)-7-hydroxy-2-naphthyl)trimethylammonium chloride
- Test material form:
- other: Dark brown powder
- Details on test material:
- - Name of test material (as cited in study report): Basic brown 17
- Molecular formula (if other than submission substance): C19H20N5O3.Cl
- Molecular weight (if other than submission substance): 401.852 g/mol
- Smiles notation (if other than submission substance):[N+](c1cc(\N=N\c2c3cc([N+](C)(C)C)ccc3ccc2O)ccc1N)([O])=O.[ClH]
- InChl (if other than submission substance): 1S/C19H19N5O3.ClH/c1-24(2,3)14-7-4-12-5-9-18(25)19(15(12)11-14)22-21-13-6-8-16(20)17(10-13)23(26)27;/h4-11H,1-3H3,(H2-,20,21,22,25);1H
- Structural formula attached as image file (if other than submission substance): No data available
- Substance type: Organic
- Physical state: Solid
- Analytical purity: No data available
- Impurities (identity and concentrations): No data available
- Composition of test material, percentage of components: No data available
- Isomers composition: No data available
- Purity test date: No data available
- Lot/batch No.: No data available
- Expiration date of the lot/batch: No data available
- Radiochemical purity (if radiolabelling): No data available
- Specific activity (if radiolabelling): No data available
- Locations of the label (if radiolabelling): No data available
- Expiration date of radiochemical substance (if radiolabelling): No data available
- Stability under test conditions: No data available
- Storage condition of test material: No data available
- Other: No data available
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Test Item Identification: B 007 ([8-[(4-amino-3-nitrophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride)
- Batch No.of test material: NDKS 1944
- Expiration date of the lot/batch: 31 December 2013
- Purity: 96.3% (HPLC)
RADIOLABELLING INFORMATION (Not applicable)
- Radiochemical purity: N/A
- Specific activity: N/A
- Locations of the label: N/A
- Expiration date of radiochemical substance: N/A
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In refrigerator in the dark.
- Stability under test conditions: Stable
- Solubility and stability of the test substance in the solvent/vehicle: No data
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: No data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The powdery test substance was instilled as delivered by the sponsor.
- Preliminary purification step (if any): No data
- Final dilution of a dissolved solid, stock liquid or gel: No data
- Final preparation of a solid: No data
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- (SPF-Quality)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: Animals used within the study were at least 6 weeks old
- Weight at study initiation: Body weights were at least 1.0 kg.
- Identification: Earmark.
- Housing: Individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56x44x37.5 cm).
- Diet (e.g. ad libitum):Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits,Altromin, Lage, Germany) approx. 100 g. per day. In addition, hay was provided at least three times a week.
- Water (e.g. ad libitum): Free access to tap-water.
- Acclimation period: 5 days before start of treatment under laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0°C (actual range: 19.0-20.7°C)
- Humidity (%): 30-70% (actual range: 38 - 80%)
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours darkne ss per day.
IN-LIFE DATES: From:06 July 2004 To:19 July 2004
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 45.4 (43.8 - 47.1) mg of the test substance (a volume of appraximately 0.1 ml).
VEHICLE (No vehicle)
- Amount(s) applied (volume or weight with unit): None - Observation period (in vivo):
- The eyes of each animal were examined approximately 1, 24, 48 and 72 hours and 7 days after instillation of the test substance.
- Duration of post- treatment incubation (in vitro):
- No data
- Number of animals or in vitro replicates:
- 3 Males.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: No data
SCORING SYSTEM:The irritation was assessed according to the numerical scoring system.
TOOL USED TO ASSESS SCORE: No data
Results and discussion
In vitro
- Other effects / acceptance of results:
- All available data relevant to the potential eye irritation/corrosivity of the substance indicated that no severe effects were to be expected. No severe reactions were noted in the skin irritation study. An in-vitro test was considered, but a negative test result was anticipated that still would have to be confirmed in an in-vivo study.
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 39,64,65
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 39,64,65
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 39,64,65
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: 39,64,65
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 39
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 39
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 39
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal: 39
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 64
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 64
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 64
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal: 64
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 65
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 65
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 65
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal: 65
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- not specified
- Irritant / corrosive response data:
- Irritation: Instillation of 45 mg of B 007 (a volume of approximately 0.1 ml) into one eye of each of three rabbits resulted in effects on the iris in two animals and on the conjunc tivae in all animals. Iridial irritation grade 1 was observed and had resolved within 24 or 72 hours.
The irritation of the conjunctivae consisted of redness, chemosis and discharge and had completely resolved within 7 days in all animals.
No corneaI opacity was observed, and treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no corneaI epithelial damage.
Corrosion
There was no evidence of ocular corrosion. - Other effects:
- - clinical observations:Colouration / Remnants
Remnants of the test substance were present in the eye 1 hour after instillation. And remnants were present on the outside of the eyelids 24 and 48 hours after instillation in one animal.Yellow-brown staining of the fur on the head and paws, caused by the test substance, was noted during the observation period.
- Other observations:Toxicity / Mortality
No symptoms of systemic toxicity were observed in the animals during the test period and no
mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Remarks:
- based on CLP criteria
- Conclusions:
- Based on the above study the test item B 007 ([8-[(4-amino-3-nitrophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride) does not have to be classified for eye irritation.
- Executive summary:
Acute eye irritation/corrosion study with B 007 ([8-[(4-amino-3-nitrophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride) in the rabbit. The study was carried out based on the guidelines described in: "Acute Toxicity - Eye irritation",OECD NoA05 (2002); EC Commission Directive 92169/EEC, B.5, "Acute Eye Irritation/Corrosion" (1992); US EPA, OPPTS 870.2400, Acute Eye Irritation, (1998) and JMAFF guidelines (2000). Single samples of approximately 45 mg of B 007 (a volume of approximately 0.1 ml) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours and 7 days after instillation. Instillation of the test substance resulted in effects on the iris in two animals and on the conjunctivae in all animals. Iridial irritation grade 1 was observed and had resolved within 24 or 72 hours. The irritation of the conjunctivae consisted of redness, chemosis and discharge and had completely resolved within 7 days in all animals. Remnants of the test substance were present in the eye 1 hour after instillation. And remnants were present on the outside of the eyelids 24 and 48 hours after instillation in one animal.Yellow-brown staining of the fur on the head and paws, caused by the test substance, was noted during the observation period. Based on these results and according to the CLP classification criteria: B 007 ([8-[(4-amino-3-nitrophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride) does not have to be classified for eye irritation.
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.