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EC number: 816-845-0 | CAS number: 1818326-42-9
- 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:
- From 6 January 2016 to 20 January 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)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 1818326-42-9
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: supplied by the sponsor
- Expiration date of the lot/batch:August 2017
- Purity test date: August 2015
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature and protected from light
- Stability under test conditions: not applicable, the test condition period was only 10 minutes
- Solubility and stability of the test substance in the solvent/vehicle: no vehicle was used
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test article was used as received
- Preliminary purification step (if any): not applicable
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: Not applicable
FORM AS APPLIED IN THE TEST (if different from that of starting material) Neat, as supplied
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Spear Products
- Number of animals: 9 corneas were used
- Characteristics of donor animals (e.g. age, sex, weight): not detailed
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): transported in HBSS medium with penicillin-streptomycin on the 7 January 2016 at the test facility
- Time interval prior to initiating testing: immediately after receipt
- indication of any existing defects or lesions in ocular tissue samples: no
- Indication of any antibiotics used: streptomycin and penicillin were used in medium
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL
- Concentration (if solution): neat
VEHICLE
No vehicle was used - Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 2 hours
- Number of animals or in vitro replicates:
- 3 replicates per condition
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
The eyes were examined prior to use on the day of dosing. Any eye with a cornea exhibiting evidence of vascularization, pigmentation, opacity or scratches was discarded. Corneas from eyes that were free of defects were dissected from the surrounding tissues. A 2-3 mm rim of sclera was left attached to each cornea. The corneas were then placed in a container of fresh HBSS. The dissected corneas were mounted in specially designed holders that were separated into anterior and
posterior chambers and filled separately. Each cornea was mounted allowing the epithelium of the cornea to project into the anterior chamber. The posterior chamber was filled with MEM solution ensuring contact with the endothelium. The anterior chamber was filled with MEM solution, ensuring contact with the epithelium. Each cornea was visually inspected again to ensure there were no defects.
The entire holder was incubated at 32ºC (± 1º) and allowed to equilibrate for at least one hour but not longer than two hours.
QUALITY CHECK OF THE ISOLATED CORNEAS
A pre-exposure determination of opacity was made for each cornea by measuring each against the blank supplied with the opacitometer. Any cornea with a value greater than 7 units was discarded.
NUMBER OF REPLICATES
3 replicates were used per condition
NEGATIVE CONTROL USED
MEM Minimal Essential Medium
POSITIVE CONTROL USED
Ethanol
APPLICATION DOSE AND EXPOSURE TIME
750 µL for 10 minutes
TREATMENT METHOD: Close Chamber
POST-INCUBATION PERIOD: Yes 2 hours
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: he test article, ethanol or MEM solution was removed from the epithelium of the cornea and anterior chamber of the holder by washing with MEM solution containing phenol red. A final rinse was made with MEM without phenol red. The anterior and posterior chambers of the holders were refilled with fresh MEM solution.
- POST-EXPOSURE INCUBATION: All corneas were incubated at 32ºC (± 1º) for an additional two hours at which time the MEM solution in the anterior and posterior chambers was removed and the holders refilled with fresh MEM solution.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: using OP-KIT
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD490)
- Others (e.g, pertinent visual observations, histopathology): (please specify)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
In Vitro Irritancy Score (IVIS) = Corrected Mean Opacity Score + (15 x Corrected Mean Optical Density Score)
DECISION CRITERIA: Criteria from OECD TG 437 was used
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Test Article - Calculated in vitro irritation score
- Value:
- 1.03
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No damage
DEMONSTRATION OF TECHNICAL PROFICIENCY: The positive control showed technical proficiency to measure a positive result
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Conform
- Acceptance criteria met for positive control: Conform; The ethanol positive control In Vitro Irritancy Score was 22.56, which fell within the acceptance range of 20.43 – 34.27 (± 2 standard deviations of the historical mean).
Any other information on results incl. tables
Table 1 :Results
Cornea ID |
Pretest Opacity Score |
10-minute Opacity Score |
2-Hour Opacity Score |
Corrected Opacity Scores1 |
OD490 nm (Permeability) |
Corrected Optical Density2 |
|
10-minute |
2-hour |
||||||
10 |
0 |
1 |
2 |
1 |
2 |
0.018 |
0.001 |
11 |
0 |
2 |
1 |
2 |
1 |
0.015 |
-0.002 |
12 |
4 |
3 |
3 |
-1 |
-1 |
0.023 |
0.006 |
Corrected Mean Optical Density3= |
0.002 |
||||||
2-Hour Corrected Mean Opacity Score4= |
1.00 |
Table 2 Calculated In Vitro Irritation Scores
Test Article |
Negative Control |
Positive Control |
HydraSynolIDL; IsosorbideDilinoleate |
|
|
(INCI name proposed); |
MEM |
100% Ethanol |
CAS# 1818326-42-9, Lot# CB 15026 |
|
|
1.00 + (15 x 0.002) |
-0.33 + (15 x 0.017) |
15.33 + (15 x 0.482) |
1.00 + 0.03 |
-0.33 + 0.255 |
15.33 + 7.23 |
IVIS = 1.03 |
IVIS = -0.07 |
IVIS = 22.56 |
Positive Control Historical Data |
|
Mean IVIS |
27.35 |
Standard Deviation |
3.46 |
n |
28 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of the study, the test item HydraSynol IDL; Isosorbide Dilinoleate induced an IVIS of 1.03. Hence, according to CLP criteria, no classification was required for the test substance for eye irritation.
- Executive summary:
This GLP compliant In Vitro study was performed in order to determine the potential for ocular irritation of the test substance HydraSynol IDL; Isosorbide Dilinoleate according to OECD 437 method (BCOP Assay)
Three bovine corneas per group were dosed with 0.75 ml of HydraSynol IDL; Isosorbide Dilinoleate, Minimal Essential Medium as negative control and Ethanol as positive control condition. Following a 10-minute exposure for each group of dosed corneas, opacity measurements and sodium fluorescein permeability were determined.
2 hours of post incubation period was performed and measurements of opacity was taken with each treated cornea compared to the blank. After 90 minutes, the fluid from the posterior chamber was removed and the amount of dye, which passed through the cornea (permeability), was measured as the optical density at 490 nm by a spectrophotometer.
Calculated IVIS values are 1.0, -0.07 and 22.56 respectively for test substance, negative and positive control.
Under the experimental conditions of the study, the test item HydraSynol IDL; Isosorbide Dilinoleate induced an IVIS of 1.03. Hence, according to CLP criteria, no classification was required for the test substance for eye irritation.
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