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EC number: 247-820-7 | CAS number: 26576-46-5
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD and GLP guideline study
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)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide
- EC Number:
- 247-820-7
- EC Name:
- N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide
- Cas Number:
- 26576-46-5
- Molecular formula:
- C11H11N3O3
- IUPAC Name:
- 3-oxo-N-(2-oxo-2,3-dihydro-1H-benzimidazol-5-yl)butanamide
- Details on test material:
- - Name of test material (as cited in study report): Acetolon TTR
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Source: Hoechst AG, Kastengrund, conventional breed
Number of animals: 3
Identification of animals: numbered earmarks
Weight of animals: 2.8 - 3.5 kg
Age of animals: 3 - 5 months
Caging: air conditioned rooms, single cages
Temperature: 20 +/- 3 °C
Relative humidity: 50 +/- 20 %
Light: 12 hrs daily
Diet: Altromin 2123 for rabbits, Altromin GmbH, Lage/Lippe, ad libitum, as well as hay (ca 15g daily)
Water: deionised, chlorinated water from automatic feeder, ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the right untreated eye of each animal served as a control
- Amount / concentration applied:
- Amount of test substance applied: 100 mg Acetolon TTR (undiluted) per rabbit eye
- Duration of treatment / exposure:
- single dose, 24 hrs after test substance application eyes where rinsed with physiol. saline solution
- Observation period (in vivo):
- 1, 24, 48 and 72 hrs after test substance application
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: mean of animal # 76, 100, 152 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Reversibility:
- other: no signs of cornea irritation (all scores 0, no other cornea effects) during the entire observation period
- Irritation parameter:
- iris score
- Basis:
- other: mean of animal # 76, 100, 152 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Reversibility:
- other: Initial, slight effects were fully reversible within 24 h.
- Irritation parameter:
- chemosis score
- Basis:
- other: mean of animal # 76, 100, 152 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Reversibility:
- other: Initial, slight effects were fully reversible within 24 h.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 76
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 100
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0.7
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 152
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- One hour after application some blood vessels of the conjuctivae of the animals showed clear hyperemia, red discoloration and swelling. The iris showed redness. 24 hours and 48 hours after application hyperemia of the blood vessels was observed only in one animal. One hour after application clear discharge was observed and one animal showed a white mucous discharge after 24 hours.
All signs of irritation were fully reversible within 72 hours.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- not eye-irritating
- Executive summary:
Acetolon TTR was tested for eye irritating properties according to OECD 405. Following this protocol 100 mg of the undiluted test substance was applied into the conjunctival sac of the left eye of 3 rabbits. The right eye remained untreated and served as control. After 24 h exposure time the eye was rinsed with physiol. saline. The eyes of the animals were examined at 1, 24, 48, and 72 h after test substance application. Mean scores (mean of 24, 48, 72 h) were calculated for cornea, iris, conjunctivae redness, and conjunctivae chemosis for each animal.
Based on the findings in this test the test substance is not eye-irritating.
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