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EC number: 614-947-8 | CAS number: 693217-63-9
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 December 2005 - 2 January 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP/Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Authors reported that they followed a modification of the Draize test and U.S. Federal Hazardous Substances Act Regulations (16 CFR 1500.42).
Reference:
IJ.H. Draize, "Dermal Toxicity", Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, (The Association of Food and Drug Officials of the United States, 1959), pp. 49 - 51. - GLP compliance:
- yes
Test material
- Reference substance name:
- Soybean oil, reaction products with ethaneperoxoic acid
- Cas Number:
- 693217-63-9
- Molecular formula:
- C59 H106 O11
- IUPAC Name:
- Soybean oil, reaction products with ethaneperoxoic acid
- Test material form:
- liquid: viscous
- Details on test material:
- Agrol 4.0 Polyol, Lot # SY-18-106 was used. The viscosity of the test material was 19,160 cP
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Six (6) New Zealand White rabbits, weighing approximately two (2) kilograms and about three (3) months of age, were obtained through a suitably licensed dealer. The animals were checked carefully upon receipt for ocular defects, diarrhea and dehydration, respiratory difficulties, postural deficiencies, and general condition. Any animal exhibiting visible ocular defects or irritation or in poor condition, was not used in this test.
Arlimals were acclimated for at least 19 days prior to test initiation. They were individually housed in stainless steel cages, in a room with a 12 hour light/dark cycle. The room temperature was controlled to comply with Animal Welfare Regulations with an approximate range of 65 to 75 F. The humidity was also monitored. The animals were identified through individual markings on the outer ear of each animal, as well as a cage label. Diet consisted of Lab Diet Certified Rabbit Diet #5322, at 100 grams per day per animal, as well as water, ad libitum.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml applied to one eye of each animal
- Duration of treatment / exposure:
- Any test material remaining in the eye was washed out after the 24-hour reading.
- Observation period (in vivo):
- Seven days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Immediately prior to test initiation, the animals were momentarily restrained. A dose of one-tenth of one milliliter (0.1 ml) of the test article was placed in one (1) eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test article was dropped. The eyelids were gently held together for one (1) second. The contralateral eye, remaining untreated, served as a control. If any of the test article remained in the eye at 24 hours, both eyes were washed out with room temperature distilled water after the 24 hour reading.
Observations of ocular irritation were recorded 24, 48 and 72 hours following instillation of the test article. Additional readings were made at four (4) and seven (7) days after application, if irritation persisted.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritant / corrosive response data:
- Redness of the Conjunctivae was observed in each animal. The value for A in the Draize rating system ranged from 1-2, resulting in a Total Score of 2-4. There was no effect noted on the Cornea or Iris or B or C as pertains to the Conjunctivae at any time during the 7 day observation period. Two of the 6 rabbits had a Conjunctivae value for A of 2 on day 7. The other 4 rabbits had been considered normal either prior to day 7 or on day 7.
- Other effects:
- No other effects noted.
Any other information on results incl. tables
Table 1 Average Draize Scores following installation of test material into the eye of 6 rabbits.
Average Draize Scores | |||||
Hours | Days | ||||
Group | 24 | 48 | 72 | 4 | 7 |
Unwashed | 3.7 | 3.3 | 2.0 | 1.3 | 0.7 |
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: U.S. Federal Hazardous Substances Act Regulations (16 CFR 1500.42)
- Conclusions:
- According to U.S. Federal Hazardous Substances Act Regulations (16 CFR 1500.42), and under the conditions of this test, this test article elicited positive responses in five (5) animals and is considered an ocular irritant
- Executive summary:
An eye irritation test was conducted using a modified Draize method. Six (6) New Zealand White rabbits, free from visible ocular defects, each received a single intraocular application of one-tenth of one milliliter (0.1 ml) of the test article in one (1) eye. The contralateral eye, remaining untreated, served as a control. The eyes of all animals remained unwashed for 24 hours. Observations of corneal opacity, iritis, and conjunctivitis were recorded 24, 48, and 72 hours after treatment, and at four (4) and seven (7) days if irritation persisted. The test article was used as received.
Average Draize Scores Hours Days Group 24 48 72 4 7 Unwashed 3.7 3.3 2.0 1.3 0.7 According to U.S. Federal Hazardous Substances Act Regulations (16 CFR 1500.42), and under the conditions of this test, this test article elicited positive responses in five (5) animals and is considered an ocular irritant
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