Registration Dossier
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EC number: 605-717-8 | CAS number: 174333-80-3
- 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
Endpoint summary
Administrative data
Description of key information
Based on the results of a study according to OECD Test Guideline 404 under GLP, the test substance is considered as skin irritating.
Based on the results of a study according to OECD Test Guideline 431 under GLP, the test substance is considered as not skin corrosive.
Based on the results of a study according to OECD Test Guideline 405, the test substance is considered as corrosive to the eye.
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:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Mol:Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Mollegaard Breeding and Research Centre A/S, Ejby, DK-4623 Lille Skensved
- Age at study initiation: no data
- Weight at study initiation: 2.0 - 2.5 kg
- Housing: individually
- Diet (e.g. ad libitum): rabbit diet "Altromin 2123" from Altromin; ad libitum
- Water (e.g. ad libitum): domestic quality drinking water acidified with hydrochloric acid to pH 2.5; ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°C
- Humidity (%): 40 - 70%
- Air changes (per hr): 10 times / hour
- Photoperiod: 12 hrs dark / 12 hrs light
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4h
- Observation period:
- 21 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: two 16-layer gauze patches (2.5 x 2.5 cm)
- Type of wrap if used: Micropore tape, 5 cm width
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lukewarm water
- Time after start of exposure: 4h
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours after termination of exposure as well as 7, 14 and 21 days
SCORING SYSTEM:
- Method of calculation: The respective scores for erythema and oedema formation for the 3 readings 24, 48 and 72 hours of each rabbit were summed up separately and divided by 6. The results are the mean scores for erythema and oedema formation of the individual rabbit. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Interpretation of results:
- Category 2 (irritant)
- Conclusions:
- Based on the results of a study according to OECD Test Guideline 404 under GLP, the test substance is considered as skin irritating (applying the evaluation system of the EU regulation 1272/2008).
- Executive summary:
The skin irritation potential of the test substance was evaluated in a study according to OECD Test Guideline 404 under GLP.
The amount of 0.5 ml of the substance was applied unchanged under semi-occlusive conditions for 4 hours to the clipped skin of three Mol:Russian rabbits, which were observed for 21 days post application. Over the first three days, clear erythema and oedema were observed in all rabbits, which reversed fully within 21 days.
Interpreting these results by applying the evaluation system of the EU regulation 1272/2008, the test substance is considered irritating to the skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- only 7 days of observation
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: LSR Industries, Union Grove, WI
no further information
ENVIRONMENTAL CONDITIONS : no data
IN-LIFE DATES: no data - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: second eye served as negative control
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 24h
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with 0.9% Saline
- Time after start of exposure: 24 h - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 4 d
- Score:
- 3
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 4 d
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 4 d
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: vesicle formation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: vesicle formation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: vesicle formation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: vesicle formation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 4 d
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: vesicle formation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 3
- Max. score:
- 4
- Remarks on result:
- other: vesicle formation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 4 d
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 4 d
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 4 d
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 3
- Max. score:
- 4
- Remarks on result:
- other: vesicle formation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: vesicle formation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: vesicle formation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: vesicle formation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 4 d
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: vesicle formation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 4 d
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 4 d
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 4 d
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: vesicle seen
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: vesicles seen
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: vesicles seen
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: vesicles seen
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 4 d
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: vesicles seen
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- other: 4 d
- Score:
- 3
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 7 d
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- other: 4 d
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- other: 1 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- other: 4 d
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 7 d
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- other: 1 h
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: vesicles seen
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: vesicles seen
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: vesicles seen
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: vesicles seen
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- other: 4 d
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: vesicles seen
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 7 d
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: vesicles seen
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- other: 4 d
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- other: 4 d
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- other: 1 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- other: 4 d
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 7 d
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- other: 1 h
- Score:
- 3
- Max. score:
- 4
- Remarks on result:
- other: vesicle formation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: vesicle formation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: vesicle formation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- other: 4 d
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: vesicle formation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- other: 4 d
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- other: 4 d
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- other: 4 d
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 7 d
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- other: 1 h
- Score:
- 3
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: vesicle formation
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 4
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- other: 4 d
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: vesicle formation
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 7 d
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: vesicle formation
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Conclusions:
- Based on the results of a study according to OECD Test Guideline 405, the test substance is considered as severly irritating to the eye (applying the evaluation system of the EU regulation 1272/2008).
- Executive summary:
The eye irritation potential of the test substance was evaluated in a study according to OECD Test Guideline 405.
The amount of 0.1 ml of the substance was applied unchanged for 24 hours to the eyes of six New Zealand White rabbits, which were observed for 7 days post application. Over the first three days, clear effects (cornea, iris, conjunctivae and chemosis) were observed, which did not fully reverse within 7 days.
Interpreting these results by applying the evaluation system of the EU regulation 1272/2008, the test substance is considered as severely eye irritating as at the end of the observation period effects still persisted.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
An in vitro study according to OECD test guideline 431 showed that the test substance is not skin corrosive. This complements the results of an in vivo study according to OECD Test Guideline 404, in which clear, but reversible (after 21 days) erythema and oedema were observed, but no corrosive effects.
Eye irritation was assessed in vivo according to OECD Test Guideline 405. Adverse effects on iris, cornea and conjunctivae were observed, which had not fully reversed at the end of the observation period, i.e. day 7. It remains unknown, if these effects would have reversed within 21 days.
Justification for classification or non-classification
Skin irritation/corrosion:
Interpreting the results of both the in vitro and in vivo test by applying the evaluation system of the EU regulation 1272/2008, the test substance is considered irritating to the skin.
Eye irritation:
Interpreting these results the results of the in vivo test by applying the evaluation system of the EU regulation 1272/2008, the test substance is considered as corrosive to the eye, because the study was terminated at observation day 7, although effects still persisted.
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