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EC number: 500-276-7 | CAS number: 89800-10-2
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 July 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
- Report date:
- 2017
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 in 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
Test material
- Reference substance name:
- ε-Caprolactone, oligomers, esters with acrylic acid and 2,2,2',2'-tetrakis (hydroxymethyl)-3,3'-oxydipropan-1-ol
- EC Number:
- 500-276-7
- EC Name:
- ε-Caprolactone, oligomers, esters with acrylic acid and 2,2,2',2'-tetrakis (hydroxymethyl)-3,3'-oxydipropan-1-ol
- Cas Number:
- 89800-10-2
- Molecular formula:
- {(C10H16O7).(C3H3O)b.[(C6H10O2)m.(C3H3O)a]} (i.e., UVCB substance)
- IUPAC Name:
- ε-Caprolactone, oligomers, esters with acrylic acid and 2,2,2',2'-tetrakis (hydroxymethyl)-3,3'-oxydipropan-1-ol
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: AB Schlachthof GmbH & Co. KG, 63739 Aschaffenburg, Germany
- Characteristics of donor animals: at least 9 month old donor cattle
- Storage, temperature and transport conditions of ocular tissue: The isolated eyes were transported in HBSS (with streptomycin / penicillin).
- Time interval prior to initiating testing: The comea were isolated on the same day after delivery of the eyes and were directly used in the BCOP test.
- Indication of any existing defects or lesions in ocular tissue samples: no
- Indication of any antibiotics used: streptomycin / penicillin
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 750 µL
- Concentration: undiluted - Duration of treatment / exposure:
- 10 min at 32 ± 1 °C
- Observation period (in vivo):
- not applicable
- Duration of post- treatment incubation (in vitro):
- 2 h at 32 ± 1 °C
- Number of animals or in vitro replicates:
- Number of eyes for the test item/ negative control/ positive control: 3 of each
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS: A careful macroscopic examination was performed on all eyes to detect the presence of any defects (opacity, scratches, pigmentation, vascularization). Eyes with defects were discarded. The cornea was carefully removed from the eye using a scalpel and rounded scissors. A rim of about 2 mm of tissue (sclera) was left for stability and handling of the isolated cornea. The cornea were directly used in the BCOP test on the same day.
QUALITY CHECK OF THE ISOLATED CORNEAS: yes, eyes were free of defects
TREATMENT METHOD: corneas were incubated horizontally, in a water-bath
REMOVAL OF TEST SUBSTANCE
After incubation the test item or control item, respectively, was rinsed off from the application side with saline.
- POST-EXPOSURE INCUBATION: The incubation medium consisted of MEM (supplemented with 1.1 g / 500 mL sodium bicarbonate, 5 mL / 500 mL L-glutamine, 100 units/mL penicillin, and 100 μg/mL streptomycin). Immediately before starting the test, MEM was supplemented with 1% fetal calf serum (FCS)). The OECD foresees the use of EMEM which is in composition and osmolarity equivalent to the MEM, thus MEM can be used without restriction.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Corneal opacity was determined by the amount of light transmission through the cornea using an opacitometer (OP_KiT opacitometer, Electro Design, 63-Riom France). After exposure of the corneae to the test groups, after rinsing and further incubation of the corneae for two hours, the opacity value was determined again (t130)
- Corneal permeability: After the final opacity measurement was performed, the complete medium was removed from the anterior compartment and replaced by 1 mL of a 0.4% (w/v) sodium fluorescein solution in HBSS. Corneae were incubated again in a horizontal position for 90 minutes in a water-bath at 32 ± 1 °C. Complete medium from the posterior compartment was removed, well mixed and transferred into a 96 well plate. Passage of sodium fluorescein dye an thus the optical density was measured with a microplate reader (Versamax® Molecular Devices) at 490 nm. The absorbance values were determined using the software SoftMax Pro Enterprise (version 4.7.1).
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
The following formula is used to determine the IVIS of the positive control and the test item:
IVIS = (opacity value - corrected opacity value mean negative control) + (15 x corrected OD490 value)
Depending on the score obtained, the test item is classified into one of the categories according to OECD 437.
DECISION CRITERIA: The decision criteria as indicated in the TG (OECD 437) was used.
VALIDATION CRITERIA: The test will be acceptable if
- the positive control gives an IVIS that falls within two standard deviations of the current historical mean (updated every three months), and if
- the negative control responses result in opacity and permeability values that are less than the established upper limits for background opacity and permeability values for bovine corneae treated with the respective negative control
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- test item - mean out of all 3 eyes
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: value is corrected
- Irritation parameter:
- fluorescein leakage
- Remarks:
- permeability
- Run / experiment:
- test item - mean out of all 3 eyes
- Value:
- 0.005
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: value is corrected
- Irritation parameter:
- in vitro irritation score
- Remarks:
- (IVIS)
- Run / experiment:
- test item - mean out of all 3 eyes
- Value:
- 0.08
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- in vitro irritation score
- Remarks:
- (IVIS)
- Run / experiment:
- positive control - mean out of all 3 eyes
- Value:
- 92.17
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, as the values of opacity and permeability (0 and 0.059, respectively) are lower than the upper limit of the historical values (0.33 and 0.08, respectively)
- Acceptance criteria met for positive control: yes, as the IVIS (92.17) falls within two standard deviations of the current historical mean (88.20 ± 21.48)
Any other information on results incl. tables
Table 1: Opacity and Permeability and In-Vitro Irritancy Score (IVIS) values
Test Group |
Opacity value = Difference (t130-t0) of Opacity |
Permeability at 490 nm (OD490) |
IVIS |
|||
|
|
Mean |
|
Mean |
|
Mean |
Negative Control |
0 |
0.00 |
0.055 |
0.059 |
0.83 |
0.88 |
0 |
0.064 |
0.96 |
||||
0 |
0.057 |
0.86 |
||||
Positive Control |
78.00* |
79.33 |
0.894* |
0.856 |
91.42 |
92.17 |
75.00* |
0.849* |
87.74 |
||||
85.00* |
0.824* |
97.37 |
||||
Test substance |
0.00* |
0.00 |
0.004* |
0.005 |
0.07 |
0.08 |
0.00* |
0.012* |
0.19 |
||||
0.00* |
-0.002* |
-0.03 |
* = corrected values
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
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