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EC number: 696-271-3 | 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 Start Date 06 Mar 2013 Experimental completion Date: 06 Mar 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- hydrogenation products of (esterification products of 2-ethylhexan-1-ol with (Estolide formation products of oleic acid and Fatty acids, C8-18 and C18-unsatd. (branched or linear)).
- EC Number:
- 696-271-3
- Molecular formula:
- n/a as UVCB
- IUPAC Name:
- hydrogenation products of (esterification products of 2-ethylhexan-1-ol with (Estolide formation products of oleic acid and Fatty acids, C8-18 and C18-unsatd. (branched or linear)).
Constituent 1
Test animals / tissue source
- Species:
- other: not applicable as this is an in vitro study
- Strain:
- other: not applicable as this is an in vitro study
- Details on test animals or tissues and environmental conditions:
- Not applicable as this is an in vitro study. However the bovine eyes were received from JW. Treuth & Sons, Inc. on 06 Mar 2013 and transported overnight to MB Research in Hank's Balanced Salt Solution with Pennstrep in a refrigerated container.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Liquids were tested undiluted. Following the pretest observations, the MEM solution was removed from the anterior chamber. A volume of 0.75 ml of the ethanol, MEM or liquid test article was applied to the epithelium of each of the three (3) positive controls, three (3) negative controls, or three (3) test articletreated corneas in a manner, which ensured the entire cornea was covered.
- Duration of treatment / exposure:
- 10 minutes
- Observation period (in vivo):
- 2 hours
- Number of animals or in vitro replicates:
- Not applicable as an in vitro study was conducted
- Details on study design:
- All holders and corneas were placed in a horizontal position (anterior side up) in the 32°C (± 1°C) incubator. After 10.:!:. 1 minute, the test article, ethanol or MEM solution in the controls were removed from the epithelium of the cornea and anterior chamber of the holder by washing with MEM solution containing phenol red. The anterior and posterior chambers of the holders were refilled with fresh MEM solution. Opacity measurements were made following the 10-minute exposure and MEM solution refill.
All corneas were incubated at 32°C (± 1°C) 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. A measurement of opacity was taken with each treated cornea compared to the blank supplied with the OPKIT. This is the reading that was used in the final in-vitro calculations.
Immediately following the 2-hour opacity measurement, the MEM solution was removed from the anterior chamber and replaced with 1.0 ml of 0.4% sodium fluorescein solution (in Dulbecco's Phosphate Buffered Saline) for liquid test articles and corresponding controls. Each holder was returned to the 32°C (± 1°C) incubator in a horizontal position (anterior side up) ensuring contact of the fluorescein with the cornea.
After 90 minutes, the fluid from the posterior chamber was removed and the amount of dye, which passed through the cornea, was measured as the optical density at 490 nm by a plate reader or spectrophotometer.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: calculated in vitro score
- Basis:
- mean
- Time point:
- other: 2 to 4 hours
- Score:
- 1.43
- Reversibility:
- fully reversible
- Remarks on result:
- other: As the scpre is < 55.1 the test substance does not need to be classified
- Irritant / corrosive response data:
- Test material - In vitro Score: 1.43
Negative Control (MEM) - In vitro score: 0.71
Positive control (ethanol) - In vitro score: 43.27 - Other effects:
- The corrected mean opacity score was 1.34. The corrected mean optical density (permeability) score was 0.006.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Conclusion: The in vitro score was calculated as 1.43.
- Executive summary:
Objective: To determine the potential for ocular irritation using an alternative to the Draize methodology. This protocol is based on the methodology described in the OECD Guideline for the Testing of Chemicals #437, adopted September 7,2009.
Method Synopsis: Three corneas were dosed with 0.75 ml of CAS# 1365345-64-7 (SE7B Batch 2137-0). Opacity measurements and sodium fluorescein permeability were determined.
Summary: The corrected mean opacity score was 1.34. Controls were within normal limits. The corrected mean optical density (permeability) score was 0.006.
Conclusion: The in vitro score was calculated as 1.43.
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