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Diss Factsheets
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EC number: 951-985-7 | 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental phase start and completion: 07 July 2020.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-amino-N-{6-[(2-aminophenyl)formamido]-2-{3-[(2-aminophenyl)formamido]propyl}hexyl}benzamide
- EC Number:
- 951-985-7
- Molecular formula:
- C30H38N6O3
- IUPAC Name:
- 2-amino-N-{6-[(2-aminophenyl)formamido]-2-{3-[(2-aminophenyl)formamido]propyl}hexyl}benzamide
- Test material form:
- solid: crystalline
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- Source of Bovine Eyes
Eyes from adult cattle (typically 12 to 60 months old) were obtained from a local abattoir as a by-product from freshly slaughtered animals. The eyes were excised by an abattoir employee after slaughter, and were placed in Hanks’ Balanced Salt Solution (HBSS) supplemented with antibiotics (penicillin at 100 IU/mL and streptomycin at 100 µg/mL). They were transported to the test facility over ice packs on the same day of slaughter. The corneas were prepared immediately on arrival.
Preparation of Corneas
All eyes were macroscopically examined before and after dissection. Only corneas free of damage were used.
The cornea from each selected eye was removed leaving a 2 to 3 mm rim of sclera to facilitate handling. The iris and lens were peeled away from the cornea. The isolated corneas were immersed in a dish containing HBSS until they were mounted in Bovine Corneal Opacity and Permeability (BCOP) holders.
The anterior and posterior chambers of each BCOP holder were filled with complete Eagle’s Minimum Essential Medium (EMEM) without phenol red and plugged. The holders were incubated at 32 ± 1 ºC for 70 minutes. At the end of the incubation period each cornea was examined for defects. Only corneas free of damage were used.
Test system
- Vehicle:
- physiological saline
- Remarks:
- For the purpose of this study the test item was prepared as a 20% w/v solution in sodium chloride 0.9% w/v.
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- .TEST MATERIAL
- Concentration (if solution): 0% w/v solution in sodium chloride 0.9% w/v
NEGATIVE CONTROL
The negative control item, sodium chloride 0.9% w/v, was used as supplied.
POSITIVE CONTROL
The positive control item, Imidazole, was used as a 20% w/v solution in sodium chloride 0.9% w/v. - Duration of treatment / exposure:
- 240 minutes
- Number of animals or in vitro replicates:
- Three replicates (corneas) per treatment (test substance, negative control, positive control).
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
QUALITY CHECK OF THE ISOLATED CORNEAS : Yes
NUMBER OF REPLICATES: Three per treatment
NEGATIVE CONTROL USED : Sodium Chloirde 0.9% w/v
SOLVENT CONTROL USED (if applicable): No
POSITIVE CONTROL USED: Imidiazole
APPLICATION DOSE AND EXPOSURE TIME : 240 minutes
POST-INCUBATION PERIOD: No
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: 3 washings with fresh complete EMEM containing phenol red before a final rinse with complete EMEM without phenol red
- POST-EXPOSURE INCUBATION: No
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Opacitometer (calibrated on the day of the test)
- Corneal permeability: passage of sodium fluorescein dye measured using microtiter plate reader at 492nm (without a reference filter)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: As specified in the test guideline.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Test Substance (mean of three replicates)
- Value:
- 1
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Remarks:
- in vitro irritancy score = 0.3
- Positive controls validity:
- valid
- Remarks:
- in vitro irritancy score = 92.4
Any other information on results incl. tables
The test item is classified according to the following criteria:
IVIS | UN GHS |
≤ 3 | No Category |
>3 ≤ 55 | No prediction can be made |
> 55 | Category 1 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the test, the test item is given No Category classification according to the UN GHS classification scheme.
- Executive summary:
Introduction
The ability of the test item to induce eye damage was assessed using a method designed to meet the requirements of the following guidelines:
- OECD Guideline for the Testing of Chemicals No. 437 (updated 09 October 2017) “Bovine Corneal Opacity and Permeability Assay”
- Method B.47 of Commission Regulation (EC) No. 440/2008
Method
The test item was applied at a concentration of 20% w/v in sodium chloride 0.9% w/v for 240 minutes. Negative and positive control items were tested concurrently. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS). Three corneas were used per treatment group.
Data Interpretation
The test item is classified according to the followign criteria:
IVIS UN GHS ≤ 3 No Category >3 ≤ 55 No prediction can be made > 55 Category 1 Results
The In Vitro irritancy scores are summarised as follows:
Treatment In Vitro Irritancy Score Test Item 1.0 Negative Control 0.3 Positive Control 92.4
Conclusion
Under the conditions of the test, the test item is given No Category classification according to the UN GHS classification scheme.
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