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EC number: 306-246-8 | CAS number: 96690-51-6
- 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:
- 13 Jun 2017 - 13 Jun 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
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:
- 2013
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Soybean oil, epoxidized, Me ester, reaction products with propylene glycol
- EC Number:
- 306-246-8
- EC Name:
- Soybean oil, epoxidized, Me ester, reaction products with propylene glycol
- Cas Number:
- 96690-51-6
- IUPAC Name:
- Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol
- Test material form:
- liquid
- Details on test material:
- Identification: Soybean oil, epoxidized, Me ester, reaction products with propylene glycol
Test item 207811/B
Appearance: Yellow liquid (determined by Charles River Den Bosch)
Purity/Composition: UVCB
Test item storage: At room temperature
Stable under storage conditions until: 17 May 2018 (expiry date)
Test item handling: No specific handling conditions required
Chemical name (IUPAC), synonym or trade name: Not indicated
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TISSUE SOURCE
- Source: Vitelco, 's Hertogenbosch, The Netherlands
- Age at study initiation: young cattle
OTHER: the eyes were excised by a slaughterhouse employee as soon as possible after slaughter. Eyes were collected and transported in physiological saline in a suitable container under cooled conditions.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750µL
- Concentration (if solution): Undiluted - Duration of treatment / exposure:
- 10 +/- 1 minutes
- Duration of post- treatment incubation (in vitro):
- 120 +/- 10 minutes
- Number of animals or in vitro replicates:
- triplicate
- Details on study design:
- SELECTION AND PREPARATION OF 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. Those exhibiting defects were discarded.
The isolated corneas were stored in a petri dish with cMEM (Earle’s Minimum Essential Medium) 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 32C. The corneas were incubated for the minimum of 1 hour at 32 C.
QUALITY CHECK OF THE ISOLATED CORNEAS
After the incubation period, the medium was removed from both compartments and replaced with fresh cMEM. Opacity determinations were performed on each of the corneas using an opacitometer. The opacity of each cornea was read against a cMEM filled chamber, and the initial opacity reading thus determined was recorded. Corneas that had an initial opacity reading higher than 7 were not used.
NUMBER OF REPLICATES
Three corneas were selected at random for each treatment group.
NEGATIVE CONTROL USED
Unexposed
POSITIVE CONTROL USED
Ethanol
APPLICATION DOSE AND EXPOSURE TIME
Undiluted 10 min exposure time
TREATMENT METHOD: closed chamber
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: at least 2
- POST-EXPOSURE INCUBATION: yes 120 +/- 10 minutes
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: measured by the diminution of light passing through the cornea using an opacitometer
- Corneal permeability: microtiter plate reader (OD490) TECAN Infinite® M200 Pro Plate Reader
- Others (e.g, pertinent visual observations, histopathology): (please specify)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: according to guideline
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Main experiment (mean of triplicate)
- Value:
- -0.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: not reported
DEMONSTRATION OF TECHNICAL PROFICIENCY:
The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (Ethanol) was 53 and was within two standard deviations of the current historical positive control mean. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Range of historical values:
Negative control
Opacity: -2.9 - 3.0, Mean=0.10, SD=1.04, n=78
Permeability: -0,016 - 0,042, Mean=0,01, SD=0,01, n=71
In vitro Irritancy Score: -2.8 - 3.0, Mean=0.20, SD=1.14, n=53
Positive control
In vitro Irritancy Score: 34.7-78.2, Mean=56.47, SD=12.48, n=53
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Remarks:
- Based on CLP (1272/2008/EC).
- Conclusions:
- Soybean oil, epoxidized, Me ester, reaction products with propylene glycol does not need to be classified for Eye irritation in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
- Executive summary:
The eye irritation hazard potential of Soybean oil, epoxidized, Me ester, reaction products with propylene glycol was as measured Acoording to OECDTG437 (BCOP test). The eye damage of
"Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol" was tested through topical application for 10 minutes. The test item was applied as it is (750 µl) directly on top of the corneas. The negative and positive were considered valid. It was therefore concluded that the test conditions were adequate and that the test system functioned properly. The test item did not induce ocular irritation through both endpoints (no corneal opacity or permeability), resulting in a mean in vitro irritancy score of -0.3 after 10 minutes of treatment. In conclusion, since the test item induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage, in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
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