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EC number: 406-040-9 | CAS number: 125643-61-0
- 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 June 20th, 1989 to June 27th, 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to OECD guideline and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (1987)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 406-040-9
- EC Name:
- -
- Cas Number:
- 125643-61-0
- Molecular formula:
- C24-26 H40-44 O3
- IUPAC Name:
- C7-9-(branched)-alkyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate
- Details on test material:
- Physical properties: yellow liquid, insoluble in water
Storage conditions: room temperature
Validity: May 1992
Test material received; May 18, 1989
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: approximately 12-14 weeks
- Weight at study initiation: 2500 to 2700 g
- Housing: individually in metal cages (and identified by individually numbered ear tags)
- Diet: standard rabbit pellet (Nafag No. 814, Gossau, Switzerland) ad libitum
- Water: fresh water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h / 12h
All batches of the diet are assayed for nutritive ingredients and contaminant level by the manufacturer.
The drinking water quality fulfilled the critical parameters in the specification of the "Schweizerisches Lebensmittelbuch" (Edition 1972).
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served for control
- Amount / concentration applied:
- 0.1 mL was instilled into the conjunctival sac of the left eye of each animal. The right eye served as untreated control.
- Duration of treatment / exposure:
- 0.1 mL was instilled into the conjunctival sac of the left eye of each animal, the lids were then held together for about one second in order to prevent loss of the test item. The treated eyes were not rinsed.
- Observation period (in vivo):
- 72 hours, extended to 7 days because reactions were observed within 72 hours after instillation of the test item.
- Number of animals or in vitro replicates:
- 3 female rabbits
- Details on study design:
- The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation according to the OECD scoring system. A slit-lamp was used to facilitate the evaluation. Because reactions were observed within 72 hours after treatment, the observation period was extended to 7 days to determine the reversibility of the eye reactions.
Moreover, the animals were checked daily for systemic symptoms and mortality.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- (mean)
- Basis:
- animal: 1, 2, 3, respectively
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Corneal opacity was seen in none of the 3 animals
- Irritation parameter:
- iris score
- Remarks:
- (mean)
- Basis:
- animal: 1, 2, 3, respectively
- Time point:
- other: 24 -48-72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Effect in the iris graded 1 was seen in 1/3 animals at reading time point 1 hour only.
- Irritation parameter:
- conjunctivae score
- Remarks:
- (mean)
- Basis:
- animal #1
- Time point:
- other: 24 -48-72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Conjunctival redness graded 1 was seen at reading time points 1 and 24 hrs but no more thereafter.
- Irritation parameter:
- conjunctivae score
- Remarks:
- (mean)
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Conjunctival redness graded 1 was seen at reading time points 1, 24 and 48 hours, and no more thereafter.
- Irritation parameter:
- conjunctivae score
- Remarks:
- (mean)
- Basis:
- animal #3
- Time point:
- other: 24 -48-72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Conjunctival redness graded 1 was seen at reading time points 1, 24 and 48 hours, and no more thereafter.
- Irritation parameter:
- chemosis score
- Remarks:
- (mean)
- Basis:
- animal: 1, 2, 3, respectively
- Time point:
- other: 24- 48-72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Chemosis graded 1 was seen in each of the 3 animals at reading time point 1 h only.
- Irritant / corrosive response data:
- Under the experimental conditions employed, iritis, conjunctival redness and chemosis, all of them graded 1, were reported for all 3 animals at reading time point 1 hour; no corneal opacity was seen. Almost all findings disappeared within 24 to 48 hours, and complete reversibility was achieved at reading time point 72 hours.
- Other effects:
- None
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU 67/548/EEC and EC/1271/2008
- Conclusions:
- Under the experimental conditions employed the test article induced minimal irritation of the iris and conjunctiva well below the threshold of significance when instilled into the conjunctival sac of albino rabbits.
- Executive summary:
The substance was instilled into the conjunctival sac of one eye in each of 3 female rabbits according to the OECD TG 405; the eyes were not rinsed. The treatment induced iritis, conjunctival redness and chemosis, all of them graded 1, in each of the 3 animals at reading time point 1 hour; no corneal opacity was seen. Almost all findings disappeared within 24 to 48 hours, and complete reversibility was achieved at reading time point 72 hours. Based on the scoring of the eye findings as recommended by the OECD guideline, the test item was not irritating to the eye of rabbit.
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