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Diss Factsheets
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EC number: 942-324-3 | 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
- Reference Type:
- other: Amendment to the report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 162691-58-9
- EC Number:
- 605-300-0
- Cas Number:
- 162691-58-9
- IUPAC Name:
- 162691-58-9
- Details on test material:
- - Name of the test substance used in the study report: Asta-C9-Acetal
- Physical state/appearance : liquid, yellowish
- Storage conditions : refrigerator, exclusion of light
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler; Offenbach / Main, FRG
- Age at study initiation: Young adult animals
- Weight at study initiation: mean body weight: 3.18 kg
- Housing: Single housing stainless steel wire mesh cages with grating, floor area : 3000 cm2
- Diet: Kliba-labordiaet 343, Klingentalmuehle AG Kaiseraugst, Switzerland. About 130 g per animal per day
- Water: about 250 mL tap water per animal per day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%
- Photoperiod: 12 h light and 12 h dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- Substance was not washed out.
- Observation period (in vivo):
- 15 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- - Readings: 1 h, 24 h, 48 h, 72 h, 8 d and 14 day after instillation
- A check for general observations and mortality was made twice each working day and once on weekends and on public holidays.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, and #3
- Time point:
- other: mean 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, and #3
- Time point:
- other: mean 24-48-72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean 24-48-72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean 24-48-72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean 24-48-72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean 24-48-72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean 24-48-72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- One female animal showed a contracted pupil at 1 hour after exposure
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Under the concitions of the performed eye irritation study, the test substance was determined to be not irritating to the eye.
- Executive summary:
The potential to cause damage to the conjunctiva, iris or cornea was assessed in an OECD 405 guideline study in compliance with GLP. Three white Vienna rabbits were subjected to a single ocular application of 0.1 mL of the test substance on day 0. The mean score (24 to 72 hours) for irritation was calculated to be 0 (all animals) for corneal opacity and iritis, 0, 1, and 0.3 for chemosis and 0.3, 2, and 1 for conjunctivae redness for animal 1, 2, and 3 respectively. The eye findings observed were reversible in one animal within 48 hours; another animal was free of signs 72 hours after instillation and in the 3rd animal the eye findings were reversible within 15 days after instillation. Based on these findings it is concluded that the test substance is not irritating to the eye
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