Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 930-936-3 | 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

Endpoint summary
Administrative data
Description of key information
Skin irritation-non-irritating for rabbits (similar to OECD TG 404).
Eye irritation-non-irritating for rabbits (similar to OECD TG 406)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report similar or equivalent to OECD 404. GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- multiple test sites per animal, including abraded test sites and occluded sites. 4h exposure was occluded
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc. Denver, PA
- Age at study initiation: young adult
- Weight at study initiation: ~ 2.0-4.0 kg - Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4-hour (occluded) and 24 hours (occluded and non-occluded)
- Observation period:
- Following the 4 hour exposure, the test sites were evaluated for dermal irritation at 4.5, 28, 52, and 76 hours. Following the 24 hour exposure, clinical observations were recorded at approximately 1 and 4 hours post-dosing and the sites were evaluated for dermal irritation at 26 and 72 hours post-exposure.
- Number of animals:
- 6 animals (3/sex).
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: intact skin, 4 hour occlusive exposure
- Other effects:
- 4 hour exposure of abraded skin under occlusive conditions resulted in a combined erythema mean of 0.47 and a combined edema mean of 0.067. Erythema was not fully reversible within 72 hours whereas edema was fully reversible within 48 hours.
24 hour exposure of non-abraded skin under non-occlusive conditions resulted in a combined erythema mean score of 1.0 at 26h and 0.2 at 72h; and a combined edema mean score of 1.0 at 26h and 0 at 72 hours after onset of exposure.
24 hour exposure of intact skin under occlusive conditions resulted in a combined erythema mean of 1.0 and the combined edema mean was 0.75; both the erythema and edema were not fully reversible within 72 hours. 24 hour exposure of abraded skin under occlusive conditions resulted in a combined erythema mean of 1.0 and a combined edema mean of 0.65; both erythema and edema were not fully reversible within 72 hours.
24 hour exposure of intact skin under non-occlusive conditions resulted in a combined erythema mean of 0.6 and the combined edema mean was 0.55; the edema, but not the erythema, was fully reversible within 72 hours. 24 hour exposure of abraded skin under occlusive conditions resulted in a combined erythema mean of 0.85 and a combined edema mean of 0.5; the edema, but not the erythema, was fully reversible within 72 hours. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The mean erythema and edema scores for the study substance were 0.36 and 0.1 (4 hour occluded), 1.0 and 0.75 (24 hour occluded), and 0.6 and 0.5 (24 hour non-occluded), respectively.This finding does not warrant classification of the study substance as a dermal irritant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) nor as an R38 skin irritant under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
The study substance was administered to the skin of New Zealand White rabbits. Test sites were selected on both the left and right flank of each animals and designated as anterior (4-hour, occluded), middle (24-hour, occluded), and posterior (24-hour, non-occluded). All sites of the right flank were abraded. 0.5 ml of the study substance was applied to each test site. Following the 4 hour exposure, the test sites were evaluated for dermal irritation at 1/2, 24, 48, and 72 hours according to the Draize method. Following the 24 hour exposures, both test sites were evaluated at 26 and 72 hours. Clinical observations were recorded at approximately 1 and 4 hours post-dosing. Slight to moderate erythema and edema were noted at each test site. Soft stool, decreased fecal output, and decreased food consumption were observed in one or more animals. The mean erythema and edema scores for the study substance were 0.36 and 0.1 (4 hour occluded), 1.0 and 0.75 (24 hour occluded), and 0.6 and 0.5 (24 hour non-occluded), respectively.This finding does not warrant classification of the study substance as a dermal irritant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) nor as an R38 skin irritant under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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: Acceptable, well-documented study report similar or equivalent to OECD 405. GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- last observation timepoint at 72 hr
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc (Denver PA)
- Age at study initiation: young adult
- Weight at study initiation: ~ 2.0-4.0 kg - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- Single instillation; the eyelids were gently held together for one second
- Observation period (in vivo):
- Clinical observations were recorded at approximately 1 and 4 hours post-dosing and daily thereafter except on weekends.
- Number of animals or in vitro replicates:
- 3 per sex
- Details on study design:
- SCORING SYSTEM: Draize method: Evaluations were made at 1, 24, 48, and 72 hours.
TOOL USED TO ASSESS SCORE: sodium fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 24 h
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 24 h
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 24 h
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- 24 h
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- 24 h
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Remarks:
- female
- Time point:
- 24 h
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 48 h
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 48 h
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 48 h
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- 48 h
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- 48 h
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Remarks:
- female
- Time point:
- 48 h
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 72 h
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 72 h
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 72 h
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- 72 h
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- 72 h
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Remarks:
- female
- Time point:
- 72 h
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 24 h
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 24 h
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24 h
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- 24 h
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- 24 h
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Remarks:
- female
- Time point:
- 24 h
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 48 h
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 48 h
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 48 h
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- 48 h
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- 48 h
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Remarks:
- female
- Time point:
- 48 h
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 72 h
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 72 h
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 72 h
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- 72 h
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- 72 h
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Remarks:
- female
- Time point:
- 72 h
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- 72 hours was the last observation timepoint
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #6
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #6
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: 72 hours was the last observation timepoint
- Irritant / corrosive response data:
- Mean DRAIZE scores for six animals at 24, 48 and 72 hrs respectively:
Corneal Opacity: 0, 0, 0
Iris Lesion: 0, 0, 0
Conjunctivae: 5.7, 3.3, 1.7 - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The mean corneal opacity, iris lesion, conjunctivae redness, and chemosis scores for the study substance were 0, 0, 0.9, and 0.4, respectively. These findings do not warrant classification of the study substance as an ocular irritant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
The study substance was administered to one eye of six New Zealand White rabbits to assess for ocular irritation; the other eye was used as a control. Clinical observations were made 1 and 4 hours immediately after treatment and daily thereafter. Ocular damage was assessed and scored according to the Draize method. Mild conjunctival redness and/or swelling were noted in all animals at 24 and/or 48 hours post-dosing. Discharge was noted sporadically throughout the study. The mean corneal opacity, iris lesion, conjunctivae redness, and chemosis scores for the study substance were 0, 0, 0.9, and 0.4, respectively. These findings do not warrant classification of the study substance as an ocular irritant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin: The dermal irritation potential of the study substance has been evaluated under occluded conditions. The results indicate negligible dermal irritation.
Eye: The ocular irritation potential of the study substance has been evaluated in a manner similar or equivalent to currently established OECD guidelines. The results indicate negligible ocular irritation.
Respiratory: The respiratory tract irritation potential of the study substance is not known, as no data are available for this endpoint.
Justification for classification or non-classification
Based on assessment of the available data for the study substance, classification is not warranted as an eye or skin irritant under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
There is no evidence of irritation to the respiratory tract warranting classification.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
