Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 916-328-0 | 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:
- 21st November 2017 - 21st December 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 Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of allyl (2-methylbutoxy)acetate and allyl (3-methylbutoxy)acetate
- EC Number:
- 916-328-0
- Molecular formula:
- C10H18O3
- IUPAC Name:
- Reaction mass of allyl (2-methylbutoxy)acetate and allyl (3-methylbutoxy)acetate
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: O’Laughlin (Nantong) Fine Chemicals Co., Ltd.; NTA375
- Expiration date of the lot/batch: Sep 25, 2020
- Purity: CAS No. 67634-00-8: 79.45 %; CAS No.: 67634-01-9 20.28 %
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Store in cool place. Keep container tightly closed in a dry and well-ventilated place.
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Breeding service CHOVSERVIS a.s., division TORO® Hlavečník, Hradec Králové, Czech Republic
Eyes were collected by slaughterhouse employees. The eyes were enucleated as soon as possible after death. No detergent was used. Only healthy animals (12 to 30 months old) considered suitable for entry into the human food chain were used as a source of corneas for use in the BCOP test. The risk of contamination was minimized (e.g., by keeping the container containing the eyes on ice, by adding antibiotics to the HBSS used to store the eyes during transport (e.g., penicillin at 100 IU/mL and streptomycin at 100 μg/mL).
The time interval between collection of the eyes and use of corneas in the BCOP was minimized (typically collected and used on the same day). The results were based on the selection criteria for the eyes, as well as the positive and negative control responses. All eyes used in the assay were from the same group of eyes collected on a specific day.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL - Duration of treatment / exposure:
- 10 minutes
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS:
The eyes, once they arrived at the laboratory, were carefully examined for defects including scratched, and neovascularisation. Only corneas from eyes free of such defects were used.
The isolated corneas, after achieve normal metabolic activity (inductive incubation at 32 ± 1°C for one hour), were examined again. The corneas that show macroscopic tissue damage (e.g., scratches, pigmentation, neovascularization) or a baseline opacity >7 opacity units were discarded.
QUALITY CHECK OF THE ISOLATED CORNEAS:
From 24 eyes the 5 eyes were eliminated after inductive incubation, because the baseline opacity values were >7. Nine corneas were used for the study (the corneas No. 1, 2, 3, 7, 8, 9, 13, 14 and 15), 4 eyes were superfluous and 6 corneas were used for testing of other substances.
NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED: 0.9% NaCl
POSITIVE CONTROL USED: 100% DMFA
APPLICATION DOSE AND EXPOSURE TIME: As a liquid, the test item was tested undiluted for 10 minutes.
TREATMENT METHOD: Closed-chamber method was used, because the test substance was applicable by micropipette. The test substance (750 µL of application form) to cover the epithelial side of the cornea is introduced into the anterior chamber through the dosing holes on the top surface of the chamber, and the holes were subsequently sealed with the chamber plugs during the exposure.
POST-INCUBATION PERIOD: Yes, two hours at 32 ± 1 ºC
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: After the exposure period, the test item was removed from the anterior chamber with EMEM (containing phenol red - the effectiveness of rinsing acidic or alkaline materials). The corneas were given a final rinse with EMEM (without phenol red). The EMEM (without phenol red) was used as a final rinse to ensure removal of the phenol red from the anterior chamber prior to the opacity measurement. The anterior chamber was then refilled with fresh EMEM without phenol red. The corneas were incubated for an additional two hours
at 32 ± 1 ºC with EMEM. At the end of the post-exposure incubation period, the opacity and permeability of each cornea were recorded.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Corneal opacity was measured quantitatively with the aid of an opacitometer (Opacitometer, MC2 - Le spécialiste du laboratoire – France) resulting in opacity values measured on a continuous scale
- Corneal permeability: 1 mL sodium fluorescein solution (5 mg/mL) was added to the anterior chamber of the corneal holder, which interfaced with the epithelial side of the cornea, while the posterior chamber, which interfaced with the endothelial side of the cornea, is filled with fresh EMEM. The holder was incubated in horizontal position for 1.5 hours at 32 ± 1 ºC. The amount of sodium fluorescein that crosses into the posterior chamber was quantitatively measured with the aid of UV/VIS spectrophotometry (Spectrophotometer GENESYSTM 10 UV/VIS Scanning). The values of absorbance measured at 490 nm were recorded as optical density (OD490) values. This term was used because the measuring is performed with visible light spectrophotometer using a standard 1 cm path length
SCORING SYSTEM: IVIS = mean opacity value + (15 x mean permeability OD490 value)
DECISION CRITERIA: A test is considered acceptable if the positive control gives IVIS that falls within one standard deviations of the current historical mean, which is to be updated at least every three months, or each time an acceptable test is conducted in laboratories where tests are conducted infrequently. The negative or solvent/vehicle control responses should result in opacity and permeability values that are less than the established upper limits for background opacity and permeability values for bovine corneas treated with the respective negative or solvent/vehicle control.
The IVIS cut-off value for identifying the test item as including serious eye damage (UN GHS Category 1) and the test item not requiring classification for eye irritation or serious damage (UN GHS No Category) is given in Table 1 below.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- AAG
- Value:
- 1.58
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 58.12
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- AAG
- Value:
- 0.022
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 0.171
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- AAG
- Value:
- 1.91
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Remarks:
- 0.85
- Positive controls validity:
- valid
- Remarks:
- 60.68
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: Appearance of corneas was observed before and after application of the test item, negative and positive control (see table 2 and 3). No macroscopic damage was observed on corneas before application. Corneal opacity was observed on the corneas treated by positive control. The corneas treated by negative control and the test item were without macroscopic damage.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The value of opacity for negative control (0.9% NaCl) obtained during the study was 0.73 and value of permeability was 0.008. The values obtained during this study not exceeded upper limits (2.86 and 0.0446, respectively), so the study is considered acceptable.
- Acceptance criteria met for positive control: The value of IVIS for positive control (100% DMFA) obtained during the study was 60.68. This value is within the acceptance limit (one standard deviations of the current historical mean; 73.89±14.95), so the study is considered acceptable.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the Bovine Corneal Opacity and Permeability (BCOP) assay, the IVIS for AAG was 1.91. As the IVIS is ≤ 3, the classification of the test substance according to UN GHS criteria for eye irritation or serious eye damage is: No category.
- Executive summary:
In the Bovine Corneal Opacity and Permeability (BCOP) assay (17-759), isolated bovine corneas were exposed to 100% Allyl Amyl Glycolate for 10 minutes using the closed chamber method. 0.9% sodium chloride was used for the negative control and 100% Dimethylformamide was used for the positive control. The corneas were rinsed twice and then incubated for an additional two hours at 32 ± 1 ºC in medium. The opacity and permeability (via sodium fluorescein dye) of each cornea were recorded.
There was no macroscopic damage to any corneas treated with the test substance There was no macroscopic damage to any corneas treated with the test substance (Table 3). The mean opacity value for the test substance was 1.58. The mean permeability OD490 for the test substance was 0.022. The IVIS for the test substance was 1.91. The positive control gave the appropriate response. The IVIS for AAG is ≤ 3 therefore the classification of test substance according to UN GHS criteria for eye irritation or serious eye damage is: No category.
This Bovine Corneal Opacity and Permeability (BCOP) is acceptable and satisfies the guideline requirement for an OECD 437 study.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.