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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 947-263-6 | 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:
- 11 July 2016 - 12 July 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- Adopted 26 July 2013
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction products of fatty acids, C16-18, C18 unsatd. with Amines, polyethylenepoly-, triethylenetetramine fraction and 3-(C9–C15, C12 rich, alk-1-enyl)dihydro-2,5-furandione
- EC Number:
- 947-263-6
- Cas Number:
- 68478-81-9
- Molecular formula:
- C36H68N4 - C76H136N4O6
- IUPAC Name:
- Reaction products of fatty acids, C16-18, C18 unsatd. with Amines, polyethylenepoly-, triethylenetetramine fraction and 3-(C9–C15, C12 rich, alk-1-enyl)dihydro-2,5-furandione
- Test material form:
- solid
- Details on test material:
- Appearance: Dark red-brown solid
Storage conditions: At room temperature
1
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: slaughterhouse (Vitelco, 's-Hertogenbosch, The Netherlands)
- Storage, temperature and transport conditions of ocular tissue: Eyes were collected and transported in physiological saline in a suitable container under cooled conditions.
- indication of any existing defects or lesions in ocular tissue samples: Eyes exhibiting defects were discarded.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 751 to 1186 mg per cornea (complete coverage)
NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 µl of physiological saline per cornea
POSITIVE CONTROL
Amount(s) applied (volume or weight with unit): 750 µl per cornea
Concentration (if solution): 20% (w/v) Imidazole - Duration of treatment / exposure:
- 240 +/- 10 minutes
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- TEST SITE
- Isolated bovine cornea
- Preparation: after being checked for unacceptable defects, the isolated corneas were stored in a petri dish with cMEM containing 1% (v/v) L-glutamine and 1% (v/v) Foetal Bovine Serum. The isolated corneas were mounted in a corneal holder (one cornea per holder) of BASF with the endothelial side against the O-ring of the posterior half of the holder. The anterior half of the holder was positioned on top of the cornea and tightened with screws. The compartments of the corneal holder were filled with cMEM of 32 ± 1 °C. The corneas were incubated for the minimum of 1 hour at 32 ± 1 °C
REMOVAL OF TEST SUBSTANCE
- Washing: yes (with MEM with phenol red (Eagle’s Minimum Essential Medium, Invitrogen Corporation) and thereafter with cMEM)
- Time after start of exposure: 240 minutes
ADDITIONAL MEASUREMENTS:
- The opacity of a cornea was measured by the diminution of light passing through the cornea. Following the final opacity measurement, permeability of the cornea to Na-fluorescein (Sigma-Aldrich, Germany) was evaluated by incubating corneas in sodium-fluorescein solution for 90 ± 5 minutes (both incubations at 32 ± 1°C). After the incubation period, the optical density at 490 nm (OD490) of each sampling tube was measured in triplicate using a microplate reader (TECAN Infinite® M200 Pro Plate Reader).
SCORING SYSTEM:
- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score:
In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
TOOL USED TO ASSESS SCORE:
- opacitymeter and microplate reader
QUALITY CHECK OF THE ISOLATED CORNEAS
The eyes were checked for unacceptable defects, such as opacity, scratches, pigmentation and neovascularization by removing them from the physiological saline and holding them in the light.
NUMBER OF REPLICATES
3
NEGATIVE CONTROL USED
yes, 3 replicates
POSITIVE CONTROL USED
yes, 3 replicates
APPLICATION DOSE AND EXPOSURE TIME
Test item was applied directly on the corneas in such a way that the cornea was completely covered. 751-1186 mg of test item was used. Corneas were incubated in a horizaontal position for 240 +/- 10 minutes.
TREATMENT METHOD: holders with corneas were placed in a horizontal position to ensure uniform distribution the solutions over the entire cornea.
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: at least 3 times
- POST-EXPOSURE INCUBATION: following opacity measurments, corneas were incubated with sodium-fluorescein solution in a horizontal position for 90 +/- 5 minutes to determine permeability.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: the opacity of a cornea was measured by the diminution of light passing through the cornea. The light was measured as illuminance by a light meter.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA:
A test substance that induces an IVIS ≤ 3 is not classified for eye irritancy (UN GHS: no category);
A test substance that induces IVIS >55 is defined as a corrosive or severe irritant (UN GHS: category 1);
A test substance that induces an IVIS >3 and ≤55, no prediction on irritant potency can be made.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Single run
- Value:
- 3.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: corneas treated with the positive control were turbid after 240 minutes of treatment and corneas treated with the test item were slightly translucent after 240 minutes of treatment.
DEMONSTRATION OF TECHNICAL PROFICIENCY: Imidazole was used as a positive control and indicated that the test system was accurate and reliable.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, results were within historical range.
- Acceptance criteria met for positive control: yes, results were within historical range.
Applicant's summary and conclusion
- Interpretation of results:
- other: No prediction on the classification can be made.
- Conclusions:
- Based on the outcome of a Bovine Corneal Opacity and Permeability test (BCOP) performed according to OECD guideline and GLP principles, it is concluded that no prediction for the classification of X-19555 for irritancy can be made, under the experimental conditions of this study, based on an IVIS of 3.8 after 240 minutes of treatment.
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.