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EC number: 217-615-7 | CAS number: 1910-42-5
- 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
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- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
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- 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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 Jun 2005 to 20 Jul 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 24 Apr 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- Aug 1998
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Paraquat-dichloride
- EC Number:
- 217-615-7
- EC Name:
- Paraquat-dichloride
- Cas Number:
- 1910-42-5
- Molecular formula:
- C12H14N2.2Cl
- IUPAC Name:
- 1,1’-dimethyl-4,4’-bipyridyldiylium dichloride
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 12 to 20 weeks old
- Weight at study initiation: 3.34 kg
- Housing: the animal was housed in a suspended metal cage, provided with environmental enrichment items which were considered not to contain any contaminant of a level
- Diet: free access to food, Certified Rabbit Diet (Code 5322)
- Water: free access to mains drinking water
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Single application of the test substance
- Observation period (in vivo):
- 35 days
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- APPLICATION OF TEST SUBSTANCE
A volume of 0.1 mL of the test substance was placed into the conjunctivae sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test material, and then released.
REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM:
- Method of calculation: the eye damage was scored according to the Draize scale scoring system (see Table 1 in 'any other information on materials and methods incl. tables').
- Assessment of ocular damage/irritation: immediately after administration of the test substance and in 1; 24; 48; 72 hours after treatment
- Additional observations to assess the reversibility of the ocular effects: on Days 7, 10, 14, 17, 21, 24, 28, 31 and 35
TOOL USED TO ASSESS SCORE:
- light source from a standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 17 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 35 days
- Irritant / corrosive response data:
- - Scattered or diffuse corneal opacity was noted in the treated eye at the 14-day observation and at all subsequent observations.
- Vascularisation, with a localised ingrowth of vessels for 2 to 3 mm, was noted in the treated eye at the 14 and 17-day observations. Vascularisation, with a localised ingrowth of vessels for 4 to 5 mm, was noted in the treated eye at the 21-day observation. Vascularisation, with a localised ingrowth of vessels for 2 to 3 mm, was noted in the treated eye at the 24-day observation and at all subsequent observations.
- Iridial inflammation was noted in the treated eye one hour after treatment and at the 24, 48, 72-hour, 7, 10 and 14-day observations.
- Moderate conjunctival irritation was noted in the treated eye one hour after treatment and at the 24, 48, 72-hour, 7, 10 and 14, 17, and 21-day observations. Minimal conjunctival irritation was noted in the treated eye at the 24, 28, 31 and 35-day observations.
- Alopecia was noted around the treated eye at the 14, 17, 21 and 24-day observations.
- The vascularisation observed at the 14-day observation was still present at the end of the observation period on Day 35. - Other effects:
- Increased salivation was noted in the animal at the 7 and 10-day observations. Bodyweight loss was noted in the animal at the 7-day observation. The animal's bodyweight was monitored and was still underweight at the 14-day observation.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- In this OECD TG 405 study, the test substance was determined to be irritating to the eyes
- Executive summary:
The GLP study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the OECD TG 405. A single application of the test material to the non-irrigated eye of one rabbit produced scattered or diffuse corneal opacity, iridial inflammation and moderate conjunctival irritation. Vascularisation, with a localised ingrowth of vessels for up to 4 to 5 mm, was noted in the treated eye. Alopecia was noted around the treated eye. Increased salivation and bodyweight loss were also noted during the study. The mean (24 -72 hours) irritation scores were determined to be 0, 1, 2 and 2 for corneal opacity, iritis, conjuctival redness and chemosis, respectively. In addition, vascularisation of the cornea was observed at the 14-day observation and was still present at the end of the observation period on Day 35.Due to the severity of the response produced in this one animal, no further animals were treated.Based these results, the test substance was determined to be an irritant to the rabbit eye.
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