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Diss Factsheets
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EC number: 268-734-6 | CAS number: 68134-22-5
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 26 AUG 1976 to 16 SEP 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: FDA guideline, similar to OECD 405.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FDA guideline (Federal Register Vol. 38, nr. 187, p. 27019, 1973)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- study was performed previous to GLP implementation
Test material
- Reference substance name:
- N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxo-2-[[2-(trifluoromethyl)phenyl]azo]butyramide
- EC Number:
- 268-734-6
- EC Name:
- N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxo-2-[[2-(trifluoromethyl)phenyl]azo]butyramide
- Cas Number:
- 68134-22-5
- Molecular formula:
- C18H14F3N5O3
- IUPAC Name:
- 3-oxo-N-(2-oxo-2,3-dihydro-1H-benzimidazol-5-yl)-2-{[2-(trifluoromethyl)phenyl]diazenyl}butanamide
- Test material form:
- solid: bulk
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: single
- Diet: ERKA 8300, Robert Koch oHG/ Hamm, Germany, ad libitum
- Water: tap water ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 100 mg - Duration of treatment / exposure:
- 24 h after exposure eyes were washed with physiological saline.
- Observation period (in vivo):
- 72 h with observation time points at 1, 7, 24, 48 and 72 h after application.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h
SCORING SYSTEM: according to Draize
TOOL USED TO ASSESS SCORE: loupe / fluorescein (for 24 and 48 h reading)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #3 and #4 each
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #2 and #5 each
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effect
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: the shortened observation period of 72 h
- Remarks on result:
- other: considered to be reversible within a prolonged observation period of 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not relevant since no effect
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: #1, #2, #3, #4 and #5 each
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not relevant since no effect
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #6
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: the shortened observation period of 72 h
- Remarks on result:
- other: considered to be reversible within a prolonged observation period of 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effect
- Irritant / corrosive response data:
- individual data for animal #1, #2, #3, #4, #5 and #6 after 1h / 7h / 24h / 48h / and 72h
cornea score: 1/1/1/0/0, 1/1/0/0/0, 2/1/1/0/0, 1/1/1/0/0, 0/0/0/0/0, 1/1/1/1/1
iris score: 0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0
conjunctivae redness: 1/1/0/0/0, 0/0/0/0/0, 1/0/0/0/0, 1/1/0/0/0, 1/0/0/0/0, 0/1/1/1/1
conjunctivae chemosis: 0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0, 0/1/0/0/0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was not irritating to eyes in all animals under test conditions which are basically in accordance with todays standard methods regarding dosing, exposure duration, scoring system and reading time points. Therefore, it is concluded that the submission substance is not irritating to eyes.
- Executive summary:
Test material was subject to a test of eye irritancy according to FDA guidelines (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973). 100 mg of substance were applied to one eye of six animals. The eyes were washed 24 h after application and eye responses were noted for 72 h after start of the exposure. No iridial effects were observed in any animal, and only 1/6 animals had a chemosis score of 1 in the 7 h reading which was completely reversible within 24 h. Slight to moderate corneal effects were visible in 5/6 animals. Apart from 1 animal these effects were completely reversible within the observation time. Conjunctivae redness was observed in 4/6 animals, the effect was also reversible within 72 h for all animals apart from one. It can be concluded that a longer observation period would have resulted in a complete reversibility.
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