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EC number: 609-724-7 | CAS number: 39605-45-3
- 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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Version / remarks:
- 1985
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Terbuthylazine
- EC Number:
- 227-637-9
- EC Name:
- Terbuthylazine
- Cas Number:
- 5915-41-3
- Molecular formula:
- C9H16ClN5
- IUPAC Name:
- N-tert-butyl-6-chloro-N'-ethyl-1,3,5-triazine-2,4-diamine
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: white powder
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Bancel (Albon - 26l40 Saint Rambert d'Albon - France
- Age at study initiation: adult males
- Weight at study initiation: 2.35-2.5 kg
- Housing: individually housed in polystyrene cages, with perforated flooring (interior dimensions 56O x 355 x 315 nim)
- Diet: approximately 150 g per animal and per day of complete pelleted rabbit maintenance diet (U.A.R. formule 112 - U.A.R,, Villemoisson - 91360 Epinay-S/Orge 7 France).
- Water: softened and filtered (5 µm) mains drinking water ad libitum (automatic dispenser)
- Acclimation period: 19 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 to 30°C
- Humidity: 30 to 60 %
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 52 mg per animal of the test article as supplied (corresponding to 0.1 ml volume) into the inferior conjunctival sac of the right eye of each of the 6 rabbits by means of a transparent plastic tube.
- Duration of treatment / exposure:
- 24 hours. The eyes were rinsed after this period, to provide evidence of any possible corneal erosion with the aid of fluorescein which was eliminated with water.
- Observation period (in vivo):
- To perform the ocular examinations the animals were immobilised on a table. These examinations were always performed under the same conditions in particular with reference to the ambient lighting. Ocular examinations were performed 1 hour after administration of the test article, then at 24, 48 and 72 hours.
- Number of animals or in vitro replicates:
- 6 male animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h
SCORING SYSTEM: OECD Guideline
TOOL USED TO ASSESS SCORE: Examination of the cornea, iris and pupil was performed with the aid of a Heine ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects recorded
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.44
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Other effects:
- No mortality was noted. There were no changes in behaviour or clinical signs in any of the treated animals during the 3 days of the observation period.
Any other information on results incl. tables
OVERVIEW OF RESULTS
Animal 1 | Animal 2 | Animal 3 | Animal 4 | Animal 5 | Animal 6 | ||
erythema | 1 h | 2 | 1 | 2 | 2 | 2 | 2 |
24 h | 2 | 2 | 1 | 2 | 1 | 1 | |
48 h | 1 | 0 | 0 | 1 | 0 | 0 | |
72 h | 0 | 0 | 0 | 1 | 0 | 0 | |
chemosis | 1 h | 1 | 1 | 1 | 1 | 1 | 1 |
24 h | 1 | 1 | 0 | 1 | 0 | 1 | |
48 h | 0 | 0 | 0 | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | 0 | 0 | 0 | |
cornea | 1 h | 0 | 0 | 0 | 0 | 0 | 0 |
24 h | 0 | 0 | 0 | 0 | 0 | 0 | |
48 h | 0 | 0 | 0 | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | 0 | 0 | 0 | |
Iris | 1 h | 1 | 1 | 1 | 1 | 1 | 1 |
24 h | 1 | 0 | 1 | 1 | 1 | 1 | |
48 h | 0 | 0 | 1 | 1 | 0 | 1 | |
72 h | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, from the results obtained under the experimental conditions, administration of this test article into the rabbit's eye can be designated as NON-IRRITANT.
- Executive summary:
The test article was administered as supplied, without rinsing and at the dose level of 52 mg (quantity corresponding to a volume of 0,1 ml) per animal, into the inferior conjunctival sac of the right eye of 6 New-Zealand hybrid albino male rabbits. The ocular examinations were performed in the conjunctiva, iris and cornea, according to a given numerical scale, 1 hour after administration of the test article, then at 24, 48 and 72 hours. Mean values were calculated from the quantitative and qualitative evaluation of ocular lesions performed in all the rabbits examined at 24, 48 and 72 hours. The average irritation scores recorded (24h ,48h ,72h) were 0.22 for chemosis, 0.67 for erythema, 0.44 for iris and 0.0 for cornea. In conclusion, from the results obtained under the experimental conditions, administration of this test article into the rabbit's eye can be designated as NON-IRRITANT.
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