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EC number: 225-833-9 | CAS number: 5107-67-5
- 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:
- Start of experiment: June 26, 1990 ; End of experiment: July 3, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-oxocyclohexane-1,1,3,3-tetrapropionic acid
- EC Number:
- 225-833-9
- EC Name:
- 2-oxocyclohexane-1,1,3,3-tetrapropionic acid
- Cas Number:
- 5107-67-5
- Molecular formula:
- C18H26O9
- IUPAC Name:
- 3-[1,3,3-tris(2-carboxyethyl)-2-oxocyclohexyl]propanoic acid
- Test material form:
- not specified
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- The albino rabbit is the recommended species for Acute Eye Irritation/Corrosion studies.
- Animal strain: New Zealand white rabbits (Chbb:NZW)
- Breeder: Dr. K. Thomae, GMBH Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Acclimatisation period: at least 5 days
The test was performed on 3 female rabbits, checked for normaleye conditions, weighing between 2320 to 2600 g (approx. 9-13 weeks old) .
The animals were housed individually in metal cages, identified by ear tattoo, kept at a constant room temperature of 20+/- 3 °C, at a relative humidity of 30-70 % and on a 12 hours light cycle day.
The rabbits received ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland - and fresh water. All batches of the diet are assayed for nutritive ingredients and contaminant level by the manufacturer. Analytical results are available at the animal supply office.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye of each animal remained untreated and served as a control.
- Amount / concentration applied:
- 0.1 ml (47 mg)
- Duration of treatment / exposure:
- one single application in the conjunctival sac of the left eye of each animal.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 female rabbits
- Details on study design:
- 0.1 ml (47 mg) of TK 1333 2 was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article.
The right eye remained untreated and served as a control.
The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of TK 13332 according to the OECD scoring system.
A slit-lamp was used to facilitate the evaluation.
SCORING SYSTEM:
CORNEA
- Opacity: degree of density (area most dense taken for reading).
- No ulceration or opacity: 0
- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible: 1
- Easily discernible translucent area, details of iris slightly obscured: 2
- Nacrous area, no details of iris visible, size of pupil barely discernible: 3
- Opaque cornea, iris not discernible through the opacity: 4
IRIS
- Normal: 0
- Markedly deepended rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive): 1
- No reaction to light, haemorrhage, gross destruction ( any or all of these ): 2
CONJUNCTIVAE
Redness : (refers to palpebral and bulbar conjunctivae, cornea and iris)
- Blood vessels normal: 0
- Some blood vessels definitely hyperaemic (injected): 1
- Diffuse, crimson colour, individual vessels not easily discernible: 2
- Diffusy beefy red: 3
Chemosis: lids and/or nictating membranes
- No swelling: 0
- Any swelling above normal (includes nictating 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
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: mean 24-72 hours
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Max score observed is 1 and this until 24 hours after application.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: mean 24-72 hours
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Max score observed is 1 and this until 24 hours after application.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Max score observed is 1 and this until 1 hour after application.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Max score observed is 1 and this during the first hour after application.
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Max score observed is 1 and this during the first hour after application.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: mean 24-72 hours
- Score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Max score observed is 2 and this until 24 hours after application and then 1 until 48 hours after application.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: mean 24-72 hours
- Score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Max score observed is 2 and this until 24 hours after application and then 1 until 48 hours after application.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: mean 24-72 hours
- Score:
- 1.67
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Max score observed is 2 and this until 48 hours after application and then 1 until 72 hours after application.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: mean 24-72 hours
- Score:
- 0.67
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Max score observed is 2 and this 1 hour after application and then 1 until 48 hours after application.
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: mean 24-72 hours
- Score:
- 0.67
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Max score observed is 2 and this 1 hour after application and then 1 until 48 hours after application.
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: mean 24-72 hours
- Score:
- 0.67
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Max score observed is 2 and this 24 hours after application and then 1 until 48 hours after application.
- Irritant / corrosive response data:
- Because reactions were observed within 72 hours after instillation of the test article, the observation period was extended to 7 days to determine the reversibility of the eye reactions.
Any other information on results incl. tables
Individual eye scores.
CORNEA | IRIS | CONJUNCTIVA | ||
Animal N° 834/F | ce/te | ce/te | ce/te | ce/te |
After 1 hr | 0/1 | 0/1 | 0/2 | 0/2 |
After 24 hrs | 0/1 | 0/0 | 0/2 | 0/1 |
After 48 hrs | 0/0 | 0/0 | 0/1 | 0/1 |
After 72 hrs | 0/0 | 0/0 | 0/0 | 0/0 |
Mean (24 - 72 hrs) | 0/0.33 | 0/0 | 0/1 | 0/0.67 |
After 7 days | 0/0 | 0/0 | 0/0 | 0/0 |
CORNEA | IRIS | CONJUNCTIVA | ||
Animal N° 888/F | ce/te | ce/te | ce/te | ce/te |
After 1 hr | 0/1 | 0/0 | 0/2 | 0/2 |
After 24 hrs | 0/1 | 0/0 | 0/2 | 0/1 |
After 48 hrs | 0/0 | 0/0 | 0/1 | 0/1 |
After 72 hrs | 0/0 | 0/0 | 0/0 | 0/0 |
Mean (24 - 72 hrs) | 0/0.33 | 0/0 | 0/1 | 0/0.67 |
After 7 days | 0/0 | 0/0 | 0/0 | 0/0 |
CORNEA | IRIS | CONJUNCTIVA | ||
Animal N° 116/F | ce/te | ce/te | ce/te | ce/te |
After 1 hr | 0/1 | 0/1 | 0/2 | 0/2 |
After 24 hrs | 0/0 | 0/0 | 0/2 | 0/2 |
After 48 hrs | 0/0 | 0/0 | 0/2 | 0/1 |
After 72 hrs | 0/0 | 0/0 | 0/1 | 0/0 |
Mean (24 - 72 hrs) | 0/0 | 0/0 | 0/1.67 | 0/1 |
After 7 days | 0/0 | 0/0 | 0/0 | 0/0 |
ce = control eye
te = test eye
M = Male
F = Female
Body weight (g)
Animal N° | 834/F | 888/F | 116/F |
At start of test | 2430 | 2600 | 2320 |
After 3 days | 2460 | 2680 | 2330 |
After 7 days (end) | 2560 | 2800 | 2460 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Regarding the results obtained 24 to 72 hours after instillation, the test item can be classified as non-irritant to albino rabbit's eye.
The eye reactions observed were reversible until the end of the observation period on day 7. - Executive summary:
The acute eye irritation/corrosion in albino rabbits was performed to determine the irritant or corrosive potency of the test item in the albino rabbit eye and the associated mucous membranes.
This test was based on the OECD Guideline N° 405, adopted in May 12, 1981.
Under the experimental conditions employed, the test item, induced irritation of the cornea, iris , and conjunctiva when instilled into the
conjunctival sac of female albino rabbits.
Because the mean values of the readings 24 t o 72 hours after instillation are below the threshold of significance, the test item can be classified as non-irritant.
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