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EC number: 259-627-5 | CAS number: 55406-53-6
- 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
Following a 4 h semi-occlusive exposure to the test item it is concluded that this material is not considered to be irritant to rabbit skin.
Based on experimental study data, the test item is considered to be a severe irritant to the ocular tissue of the rabbit.
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
- Study period:
- 1989-09-05 to 1989-09-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: P-8907-4914-P100
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the dark under ambient conditions - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Cheshire Rabbit Farms Limited
- Age at study initiation: young adult
- Housing: individually in aluminium cages with grid floors
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 d
ENVIRONMENTAL CONDITIONS
- Temperature: mean 18 °C
- Humidity: mean 65 %
- Photoperiod: 12 h (07:00 - 19:00) light; 12 h dark - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g moistened with water - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3 males, 3 females
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of trunk
- coverage: 2.5 cm x 2.5 cm gauze patch
- Type of wrap if used: micropore tape
REMOVAL OF TEST SUBSTANCE
- Washing: skin was wiped with damp tissues
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
Skin reactions were assessed 1, 24, 48 and 72 h after patch removal
SCORING SYSTEM:
According to EPA recommended scoring system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: no further observations performed after 72 h post exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Slight - moderate erythema (score 1 and 2) and slight oedema (score 1) were noted in 2 of the 6 rabbits 24 h after patch removal with slight erythema persisting in one rabbit until the 72 h assessment. Latter showed a decreasing trend in erythrema score.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Following a 4 h semi-occlusive exposure to the test item it is concluded that this material is not considered to be irritant to rabbit skin.
- Executive summary:
The primary skin irritation potential of the test material was investigated in New Zealand White rabbits.
Following a 4 h semi-occlusive exposure of the test item slight-moderate erythema and slight oedema were noted in 2 rabbits 24 h after patch removal, with slight erythema persisting in one rabbit until the 72 h assessment. Latter showed a decreasing trend in erythrema score. It remains unclear if longer observation period could have revealed full reversibilty.
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
- Study period:
- 1990-03-27 to 1990-06-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 89115175
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Mohican Valley Rabbitry, Loudonville, Ohio
- Age at study initiation: adult
- Weight at study initiation: 2.0 - 2.4 kg
- Housing: individually; in suspended stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: min. 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 16.1 - 21.1 °C (61 - 70 °F)
- Humidity: 40 - 60 %
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: 1990-03-27 to 1990-04-17 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.055 mg; equivalent to 0.1 mL - Duration of treatment / exposure:
- 30 seconds
- Observation period (in vivo):
- Both eyes of each animal were examined for signs of irritation at 1, 24, 48 and 72 hours and up to 21 days after dosing using the ocular irritation grading system.
- Number of animals or in vitro replicates:
- 3 rinsing group, 6 non rinsing group
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: rinsing with 50 mL of physiological saline (three of nine animals)
- Time after start of exposure: 30 sec
SCORING SYSTEM: according to EPA guideline
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- No rinse group
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- No rinse group
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- No rinse group
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Remarks:
- No rinse group
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Remarks:
- No rinse group
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Remarks:
- No rinse group
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #7
- Remarks:
- Rinsed group
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #8
- Remarks:
- Rinsed group
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #9
- Remarks:
- Rinsed group
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- No rinse group
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- No rinse group
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- No rinse group
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Remarks:
- No rinse group
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Remarks:
- No rinse group
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Remarks:
- No rinse group
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- iris score
- Basis:
- animal: #7
- Remarks:
- Rinsed group
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- iris score
- Basis:
- animal: #8
- Remarks:
- Rinsed group
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal: #9
- Remarks:
- Rinsed group
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- No rinse group
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- No rinse group
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- No rinse group
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Remarks:
- No rinse group
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Remarks:
- No rinse group
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Remarks:
- No rinse group
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #7
- Remarks:
- Rinsed group
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #8
- Remarks:
- Rinsed group
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #9
- Remarks:
- Rinsed group
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- No rinsed group
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- No rinsed group
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- No rinsed group
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Remarks:
- No rinsed group
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Remarks:
- No rinsed group
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Remarks:
- No rinsed group
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- chemosis score
- Basis:
- animal: #7
- Remarks:
- Rinsed group
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- chemosis score
- Basis:
- animal: #8
- Remarks:
- Rinsed group
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal: #9
- Remarks:
- Rinsed group
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritant / corrosive response data:
- No irritation was observed in the control eyes. Normal background fluorescein dye retention (stippling/mechanical abrasions) was noted in 4/9 control eyes but was not considered significant.
In the no rinse test group, exposure to the test article produced substantial injury to the ocular tissue of the rabbit. Corneal opacity was observed in 6/6 test eyes by the 24 hour scoring interval. The corneal injury was associated with corneal epithelial sloughing and further confirmed by positive fluorescein dye retention. Normal background fluorescein dye retention (stippling) was also observed in 3/6 test eyes but was not considered significant. The corneal opacity persisted in all no rinse test eyes to test termination (day 21) and was accompanied by corneal vascularization. Iritis was observed in 6/6 test eyes at 1 hour postdose and resolved in all no rinse animals by day 21. Conjunctivitis (redness, swelling and discharge) was noted in 6/6 test eyes at the 1 hour scoring interval. The conjunctival irritation diminished over the test period but persisted to study day 21.
In the rinsed test group, exposure to the test article followed by a saline rinse resulted in a decrease in the severity and duration of the ocular response. In 2/3 rinsed test eyes, iritis was observed at the 1 hour postdose and resolved by 48 hours. Conjunctival irritation was also noted in these two test eyes at 1 hour postdose and resolved by day 7. In the remaining rinsed test animal, ocular responses generally resembled those noted in the rinsed test group. However, all reactions in this latter animal resolved by 21 days postdose. - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on the no rinse test data, the test item is considered to be a severe irritant to the ocular tissue of the rabbit. Ocular reactions in rinsed test eyes were less severe and completely reversible by 21 days postdose.
- Executive summary:
The potential eye irritant and/or corrosive effects of the test item were evaluated in New Zealand White rabbits. Each of nine animals received a 0.055 g dose (0.1 mL equivalent) of the test article in the conjunctival sac of the right eye. The contralateral eye of each animal remained untreated and served as a control. At 30 seconds postinstillation, both eyes of three rabbits were rinsed with 50 mL of physiological saline (rinsed group); no rinsing procedure was utilized on the six remaining rabbits (no rinse group). Test and control eyes were examined for signs of irritation for up to 21 days following dosing.
In the no rinse test group, exposure to the test article produced substantial injury to the ocular tissue of the rabbit. Corneal opacity was observed in 6/6 test eyes by the 24 hour scoring interval. The corneal injury was associated with corneal epithelial sloughing and further confirmed by positive fluorescein dye retention. Normal background fluorescein dye retention (stippling) was also observed in 3/6 test eyes but was not considered significant. The corneal opacity persisted in all no rinse test eyes to test termination (day 21) and was accompanied by corneal vascularization. Iritis was observed in 6/6 test eyes at 1 hour postdose and resolved in all no rinse animals by day 21.Conjunctivitis (redness, swelling and discharge) was noted in 6/6 test eyes at the 1 hour scoring interval. The conjunctival irritation diminished over the test period but persisted to study day 21.
In the rinsed test group, exposure to the test article followed by a saline rinse resulted in a decrease in the severity and duration of the ocular response. In 2/3 rinsed test eyes, iritis was observed at the 1 hour postdose and resolved by 48 hours. Conjunctival irritation was also noted in these two test eyes at 1 hour postdose and resolved by day 7. In the remaining rinsed test animal, ocular responses generally resembled those noted in the rinsed test group. However, all reactions in this latter animal resolved by 21 days postdose.
Based on the no rinse test data, the test item is considered to be a severe irritant to the ocular tissue of the rabbit.As noted above, ocular reactions in rinsed test eyes were less severe and completely reversible by 21 days postdose.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation in vivo
The primary skin irritation potential of the test material was investigated in New Zealand White rabbits.
Following a 4 h semi-occlusive exposure of the test item slight-moderate erythema and slight oedema were noted in 2 rabbits 24 h after patch removal, with slight erythema persisting in one rabbit until the 72 h assessment. Latter showed a decreasing trend in erythrema score. It remains unclear if longer observation period could have revealed full reversibilty.
Eye irritation in vivo
The potential eye irritant and/or corrosive effects of the test item were evaluated in New Zealand White rabbits. Each of nine animals received a 0.055 g dose (0.1 mL equivalent) of the test article in the conjunctival sac of the right eye. The contralateral eye of each animal remained untreated and served as a control. At 30 seconds postinstillation, both eyes of three rabbits were rinsed with 50 mL of physiological saline (rinsed group); no rinsing procedure was utilized on the six remaining rabbits (no rinse group). Test and control eyes were examined for signs of irritation for up to 21 days following dosing.
In the no rinse test group, exposure to the test article produced substantial injury to the ocular tissue of the rabbit. Corneal opacity was observed in 6/6 test eyes by the 24 hour scoring interval. The corneal injury was associated with corneal epithelial sloughing and further confirmed by positive fluorescein dye retention. Normal background fluorescein dye retention (stippling) was also observed in 3/6 test eyes but was not considered significant. The corneal opacity persisted in all no rinse test eyes to test termination (day 21) and was accompanied by corneal vascularization. Iritis was observed in 6/6 test eyes at 1 hour postdose and resolved in all no rinse animals by day 21. Conjunctivitis (redness, swelling and discharge) was noted in 6/6 test eyes at the 1 hour scoring interval. The conjunctival irritation diminished over the test period but persisted to study day 21.
In the rinsed test group, exposure to the test article followed by a saline rinse resulted in a decrease in the severity and duration of the ocular response. In 2/3 rinsed test eyes, iritis was observed at the 1 hour postdose and resolved by 48 hours. Conjunctival irritation was also noted in these two test eyes at 1 hour postdose and resolved by day 7. In the remaining rinsed test animal, ocular responses generally resembled those noted in the rinsed test group. However, all reactions in this latter animal resolved by 21 days postdose.
Based on the no rinse test data, the test item is considered to be a severe irritant to the ocular tissue of the rabbit. As noted above, ocular reactions in rinsed test eyes were less severe and completely reversible by 21 days postdose.
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. Based on
available data on eye irritation, the
test item is classified and labelled as severe eye damaging (H318:
"Causes serious eye damage") according
to Regulation (EC) No 1272/2008 (CLP), as amended for the eighth time in
Regulation (EU) No 2016/918.
Classification on skin irritation is not warranted.
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