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EC number: 609-496-9 | CAS number: 379685-94-6
- 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:
- From 13 August 2002 to 09 December 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 24th February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 31st July 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Glycine, N-acetyl-N-[3-(trifluoromethyl)phenyl]valyl-, ethyl ester
- EC Number:
- 609-496-9
- Cas Number:
- 379685-94-6
- Molecular formula:
- C18H23F3N2O4
- IUPAC Name:
- Glycine, N-acetyl-N-[3-(trifluoromethyl)phenyl]valyl-, ethyl ester
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Other: ochre fine powder
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL- Storage condition of test material: room temperaturepH OF TEST ITEM: approximately 5 at the concentration of 10% in purified water, measured at thetesting laboratory.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: CEGAV, Saint Mars d'Egrenne, France.- Age at study initiation: 2 to 4 months old- Weight at study initiation: 3.1 ± 0.1 kg- Housing: animals were housed individually in polystyrene cages (48.2 cm x 58 cm x 36.5 cm). Each cage was equipped with a food container and a water bottle.- Diet: ad libitum to 110 pelleted diet (UAR, Villemoisson, Epinay-sur-Orge, France). Diet was analysed regularly by the supplier for composition and contaminant levels (dietformula was available in the study report).- Water: ad libitum to drinking water filtered by a FG Millipore membrane (0.22 micron). Bacteriological and chemical analyses of water were performed regularly by extemal laboratories (include detection of possible contaminants (pesticides, heavy metals andnitrosamines)).- Acclimation period: at least five days.ENVIRONMENTAL CONDITIONS- Temperature (°C): 18±3°C- Humidity (%): 30 to 70%- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air.- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated right eye served as control
- Amount / concentration applied:
- 0.1 g of the test item in its original form
- Observation period (in vivo):
- 1 hour, 24, 48 and 72 hours after administration of the test item. As no persistent ocular reaction was obserevd, the study was ended on day 4.
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- PRIOR TO TREATMENT: both eyes of each animal were examined 21 hours before tratment in order to reject any animal showing signs of ocular lesions, ocular defects of pre-existing corneal injury.ADMINISTRATION OF TEST SUBSTANCE: As no irritant effects effects were anticipated, the study was directly performed on three animals. the test substance was introduced in its original form into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball. After the application, the lower and upper eyelids were held together for approximately one second to avoid any loss of test item.REMOVAL OF TEST SUBSTANCE- Washing (if done): no washingEVALUATION OF OCULAR REACTIONS:Conjunctival reactions, iritis and comeal opacification were evaluated daily for each animal. TOOL USED TO ASSESS SCORE: For the evaluation of comeal opacification (presence or absence, affected area), the eyes were examined under a UV lamp after instillation of one or two drops of 0.5% sodium fluorescein solution (a clear fluorescence is visible in the areas of opacification). This evaluation was performed on day 2 and repeated thereafter whenever necessary.SCORING SYSTEM:Ocular reactions were scored according to the following numerical scale: Coniunctival lesions and dischargeChemosis (lids and/or nictitating membranes) . no swelling...............................................................................................................................0 . any swelling above normal (includes nictitating membranes)................................................. 1 . obvious swelling with partial eversion of lids..........................................................................2 . swelling with lids about half-closed.........................................................................................3 . swelling with lids more than half-closed..................................................................................4 Redness (refers to palpebral and bulbar conjunctivae, comea and iris) . bloodvessels normal................................................................................................................0 . a number ofblood vessels definitely hyperemic (injected)...................................................... 1 . diffuse, crimson colour, individual vessels not easily discemible ...........................................2 . diffuse, beefy red......................................................................................................................3 Discharge . absence of discharge.................................................................................................................0 . slight discharge (does not include small amounts normally found in inner canthus)........................................................................................................................... 1 . discharge with moistening of lids and hairs adjacent to lids....................................................2 . discharge with moistening of lids and hairs on wide area around the eye ...............................3 Iris lésions . normal ......................................................................................................................................0 . markediy deepened rugae, congestion, swelling, moderate circum-comeal hyperemia, or injection, any of thèse or combination ofany thereof, iris still reacting to light (sluggish reaction is positive) ........................................................................ 1 . no reaction to light, haemorrhage, gross destruction (any or ail of thèse) ...............................2
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: a score of 0 was obtained at the 1h observation time point
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: a score of 0 was obtained at the 1h observation time point
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: a score of 0 was obtained at the 1h observation time point
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: a score of 0 was obtained at the 1h observation time point
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: a score of 0 was obtained at the 1h observation time point
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: a score of 0 was obtained at the 1h observation time point
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: a score of 2 was obtained at the 1h observation time point
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: a score of 2 was obtained at the 1h observation time point
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: a score of 2 was obtained at the 1h observation time point
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: a score of 1 was obtained at the 1h observation time point
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: a score of 2 was obtained at the 1h observation time point
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: a score of 1 was obtained at the 1h observation time point
- Irritant / corrosive response data:
- Very slight or slight conjunctival reactions, including a very slight or slight chemosis (grade 1 or 2), a very slight or slight redness of the conjunctiva (grade 1 or 2) and a clear discharge (grade 1 or 2), were observed in all animals, at 1h and 24 hours only. No other ocular reactions were observed during the study. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.00, 0.00 and 0.00 for comeal opacity, 0.00, 0.00 and 0.00 for iris lesions, 0.33, 0.33 and 0.33 for redness of the conjunctiva and 0.33, 0.00 and 0.33 for chemosis.
- Other effects:
- None.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the test material is not classified as irritating to the eye according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) criteria.
- Executive summary:
This GLP-compliant study was performed to assess the potential of the test material to induce eye irritation in vivo, according to OECD Guideline 405 (dated February 24th, 1987) and EU method B.5 of the E.E.C. directive n° 92/69 (dated July 31st, 1992).
Material and methods
0.1 g of the test material were introduced as supplied, into one eye of each of the 3 male rabbits, the other untreated seye erving as control. Ocular examinations were performed on both right and left eyes 1 hour
and then 24, 48 and 72 hours after instillation.
Results
Ocular reactions (redness of the conjunctivae, chemosis and discharge) were observed during the study but were all fully reversed 48 hours after the administration of the test material. The individual mean scores for each animal (24, 48 and 72 hours) were 0.00, 0.00 and 0.00 for comeal opacity, 0.00, 0.00 and 0.00 for iris lesions, 0.33, 0.33 and 0.33 for redness of the conjunctiva and 0.33, 0.00 and 0.33 for chemosis.
Conclusion
Under the experimental conditions of this study, the test material is not classified as irritating to the eye according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) criteria.
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