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Diss Factsheets
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EC number: - | 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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- of 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- other: semi-solid, wax-like (at 20°C)
- Details on test material:
- - Name of test material (as cited in study report): WS400102
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Number and Sex: 3 males
- Animal supplier: S&K-LAP Kft., 2173 Kartal, Császár út 135, Hungary
- Age on day of dosing (Day 0): Ca. 11 weeks old (young adult)
- Weight prior to dosing (Day 0): Minimum 2690 g, maximum 2948 g
- Housing: Individual housing in AAALAC approved metal wire rabbit cages allowing for some
social interaction with rabbit(s) in adjacent cages
- Diet (ad libitum): Commercially available rabbit diet, AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Hungary
- Water (ad libitum): Tap water from municipal supply
- Acclimation period: 7 days prior to study start under laboratory conditions.
Water was regularly analysed for contaminants, detailed information on the diet was provided by the supplier. Water and diet used in the present study were not considered to adversely affect the purpose or integrity of the study.
ENVIRONMENTAL CONDITIONS
Controlled environment, environmental conditions were:
- Ventilation, air changes per hour: 15-20
- Temperature (°C): 19.7 to 27.1°C
- Relative Humidity (%): 32 to 83%
- Photoperiod (artificial lighting): 12 hrs day / 12 hrs night
Relative humidity and temperature at times slightly exceeding the upper target limits of 70% and 23°C, respectively were not considered to have compromised the integrity or validity of the study.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL of the undiluted wax-like test material was administered into the conjunctival sac of one eye per rabbit (left eye). The contralateral eye (right eye) remained untreated to serve as a control.
- Duration of treatment / exposure:
- Residual test material was seen in the treated eyes. Therefore, the eyes were rinsed with physiological saline at 1 hour after test material instillation.
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3 adult male rabbits
- Details on study design:
- EYE EVALUATION:
Within 2.5 hours before treatment start both eyes of each animal were investigated to ensure that there were no pre-existing corneal damage, eye irritation or ocular defects.
One animal was initially treated and, in the absence of a severe effect at 1 hour post instillation, the remaining two animals were committed to the study.
Eyes were evaluated in all animals at approximately 1, 24, 48 & 72 hours and 7, 14 & 21 days after test material instillation adopting the numerical scoring system listed in Table 1 in the field below. Grades attained at 24, 48 and 72 hours after instillation were included in the mean gradings of ocular lesions and used for evaluation of the necessity of eye irritation/corrosion classification.
Equipment used for eye evaluation: Ophthalmoscope or pencil beam torch
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- other: corneal area affected
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- other: Discharge
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- other: Discharge
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- other: Discharge
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Iridic lesions were not evident throughout the study. Corneal lesions (opacity grade 1, except for grade 2 in one animal at 1 h after test material instillation) were seen in all animals until 72 hours after test material instillation and had entirely disappeared in all animals by 7 days after instillation. In each animal, the area of cornea affected was scored grade 4 to 0. Conjunctival redness grade 2, chemosis grade 3 and discharge grade 3, were seen in all animals at 1 h after instillation, therafter gradually decreasing in severity and incidence. By 7 days after instillation chemosis and discharge had fully disappeared in all animals and by 21 days after instillation conjunctival redness had fully disappeared. Control eyes were without ocular findings throughout the observation period.
- Other effects:
- Observation of the animals for defined behavioural criteria led to the conclusion that instillation of the test material induced slight initial pain (grade 2). Any other signs of systemic toxicity or ill health were not evident and bodyweight was unaffected by treatment with the test material.
Applicant's summary and conclusion
- Interpretation of results:
- other: irritating
- Conclusions:
- The substance is irritating to eyes. All findings noted were fully reversible.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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