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Diss Factsheets
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EC number: 944-892-8 | 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:
- 2009-11-09 to 2009-11-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- Gautheron P. and al (Fundam. Appl. Toxicol. 1992, 18, 442-449)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of butyl palmitate and butyl oleate and butyl (9Z,12Z)-octadeca-9,12-dienoate and 482-680-2
- EC Number:
- 944-892-8
- Molecular formula:
- not applicable
- IUPAC Name:
- Reaction mass of butyl palmitate and butyl oleate and butyl (9Z,12Z)-octadeca-9,12-dienoate and 482-680-2
- Test material form:
- liquid: viscous
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Corneas of calves aged less than 8 months, fresh and conserved.
Bovine eyes were collected in the abatoirs of Sobeval Boulazac 24759 - France, immediately after killing of the animals, and transported in a Hank's buffered saline solution to the laboratory.
The eyes were carefully examined and these showing a visible defect were eliminated. An incision was made in each selected eye on the scleral ring taking care to leave approximately 2 to 3 mn of scleral ring to ease the further hadlings.
Then the corneas were used or kept for a maximal of 24 hours at 4°C +/- 2°C in a preservative medium.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- The test element was tested as supplied.
750 µL of test element and negative control were introduced by one of the openings of the holder. - Duration of treatment / exposure:
- The treatment lasted (time of contact) 30 minutes and 4 hours.
- Duration of post- treatment incubation (in vitro):
- 1 hour and 30 minutes of post treatment incubation for the measurements of the corneal permeability with a fluorescein solution.
- Number of animals or in vitro replicates:
- For each time of contact 3 corneas served as negative control and 3 corneas received the test element.
- Details on study design:
- Preparation of the test element:
The test element was tested as supplied. The test element was tested at room temperature.
Mounting of corneas:
Corneas were deposited, epithelial side upwards, on the lower part of cornea holders. Then the upper part was firmly clamped in place with 3 screws. The anterior (epithelial side) and posterior (endothelial side) compartments were then filled with nutritive medium, with an eppendorf pipette, taking care to eliminate air bubbles and starting by the lower part. The waterlightness was insured by toric joints. Each cornea was identified by the number of the corresponding holder. As soon as the corneas were mounted, the holders were maintained at 32°C for 1 hour (pre-incubation) in a bain-marie, in horizontal position, immersed at the three-quarters of their height. After this period of pre-incubation, the opacity at T0 (OPT0) was determined.
Treatment of corneas:
At the end of pre-incubation, both compartments were completely and carefully emptied starting by the anterior compartment. The posterior compartment was filled again with nutritive medium whereas the anterior compartment received the test element: 750µL was introduced by one of the openings of the holder. For each time of contact 3 corneas served as negative control and 3 corneas received the test element. The control corneas received 750 µL of nutritive medium. A chronometer was set off for each series of three corneas. The holders were then incubated, in bain-marie (32°C) in vertical position and immersed in such a way that the test element remained in contact with the cornea. The treatment lasted (time of contact) 30 minutes and 4 hours.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 30 minutes
- Value:
- 1.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Weakly irritant
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 4 hours
- Value:
- 1.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Weakly irritant
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- According to the defined grading scale, the test element 5 alpha AVOCUTA(R) - Code: 8700492 / CAS: 934551 -20 -9 tested as supplied was judged weakly irritant to the calf cornea. The response obtained for the test element cannot be compared, due to a lack of historical data in that category of product (cosmetic ingredient).
- Executive summary:
Title: Assessment of the irritant potential of a test element after application to the isolated calf cornea (BCOP)
Objectives: The aim of the study was to assess quantitatively the irritant potential of a test element after application to the isolated calf cornea. The assessment was based on the measurement of two parameters: the opicty and permeability of the cornea whose deteriorations reflected the damage of the tissue. The test element was let in contact with the isolated cornea for 30 minutes and 4 hours. On the basis of the results obtained for each time of contact, a corneal score was calculated and the test element classified.
Test item: 5 alpha AVOCUTA(R) - Code : 8700492 / CAS: 934551 -20 -9 - BATCH: 0809402304
Test System: Corneas of calves aged less than 8 months, fresh and conserved. Bovine eyes were collected in the abattoirs of Sobeval Boulazac 24759 - France.
Conlusion: According to the defined grading scale, the test element 5 alpha AVOCUTA(R) - Code: 8700492 / CAS: 934551 -20 -9 tested as supplied was judged weakly irritant to the calf cornea. The response obtained for the test element cannot be compared, due to a lack of historical data in that category of product (cosmetic ingredient).
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