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Diss Factsheets
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EC number: 919-276-7 | 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:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- n-phenyl n-acetoacetyl glycine ethyl ester
- IUPAC Name:
- n-phenyl n-acetoacetyl glycine ethyl ester
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- TEST MATERIAL NAME (as stated in study report): Internediate F37
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Valtris Specialty Chemicals Ltd. / Batch/Lot No. W042272
- Expiration date of the lot/batch: November 21, 2019
- Purity: 84.5%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature. Containers kept tightly closed in a dry, cool and well ventilated place.
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Test System : Isolated Cornea from the eyes of freshly slaughtered cattle
Source : Deonar Abattoir slaughter house, Mumbai, Maharashtra
Bovine Age : Between 1 to 5 years (age of the animals was determined based on the teeth count and horn ring count along with Horizontal Diameter of Corneas and Central Corneal Thickness)
Transportation Condition : Transported (in a sealed plastic container) under cold condition in Hanks’ Balanced Salt Solution containing antibiotics [e.g., penicillin at 100 IU/mL and streptomycin at 100 μg/mL]
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
- Concentration (if solution): undiluted
- Duration of treatment / exposure:
- approximately 10 minutes ± 30 seconds
- Duration of post- treatment incubation (in vitro):
- approximately 2 hours ± 10 minutes
- Number of animals or in vitro replicates:
- three corneas per test group
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
The eyes were used within 24 hours from slaughter. Eyes were examined prior to use. Corneas from eyes free of visible defects were used. Corneas that have opacity lesser than seven opacity units or equivalent for the opacitometer were used in the study.
Corneas, free from defects, were dissected to a 2 to 3 mm rim and were transferred to container containing Hanks’ Balanced Salt Solution containing antibiotics [e.g., penicillin at 100 IU/mL and streptomycin at 100 μg/mL].
Selected corneas were mounted on the corneal holders with the endothelial side against the O-ring of the posterior half of the holder. The anterior half of the holder was then placed on the top of the cornea and fixed in place. Both chambers were then filled to excess with pre-warmed phenol red free Eagle's Minimum Essential Medium (EMEM) (posterior chamber first to return the cornea to its natural concave position), ensuring no bubbles were present within the holders. The device was then equilibrated at 32 ± 1°C for at least one hour to allow the corneas to equilibrate with the medium and to achieve normal metabolic activity, to the extent possible. Following the equilibration period, the medium was removed from both the chambers and fresh pre-warmed phenol red free EMEM was added to both chambers and baseline opacity readings were taken for each cornea.
REMOVAL OF TEST SUBSTANCE
At the end of exposure period, the test item, positive control and negative control were removed from their respective anterior chamber and the corneal epithelium washed until no visual evidence of test item, positive control or negative control was observed using EMEM (containing phenol red).
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: light transmission
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of [UV/VIS spectrophotometry
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: per test guideline
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Remarks:
- IVIS
- Value:
- 0.53
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- DEMONSTRATION OF TECHNICAL PROFICIENCY:
yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not classified by CLP Criteria
- Conclusions:
- Under guideline (OECD 437) test conditions, the mean IVIS score for Intermediate F37 in the bovine corneal opacity and permeabilty (BCOP) test was 0.53. Based on these results, Intermediate F37 is not classified for eye irritation or serious eye damage.
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