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EC number: 259-571-1 | CAS number: 55290-62-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- 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
The test substance is considered as not irritating to the skin and eyes of rabbits.
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:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: twelve to sixteen weeks
- Weight at study initiation: 2.77 to 2.99 kg
- Housing: individually housed in suspended metal cages
- Diet: Free access to food (STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK)
- Water: Free access to mains drinking water
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: moistened with water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal flank
- Type of wrap if used: elasticated corset (TUBIGRIP)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed by gentle swabbing with cotton wool soaked in distilled water .
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No evidence of skin irritation was noted during the study .
- Other effects:
- Yellow-coloured staining was noted at all treated skin sites throughout the study. The staining did not affect evaluation of skin responses.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a primary irritation index of 0.0 and was classified as NON-IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
- Executive summary:
A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404. A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced no evidence of skin irritation. The test material produced a primary irritation index of 0.0 and was classified as nonirritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
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:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: twelve to sixteen weeks
- Weight at study initiation: 2.51 to 2.93 kg
- Housing: individually in suspended metal cages
- Diet: Free access to food (STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK)
- Water: Free access to mains drinking water
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye remained untreated and was used for control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (about 54 mg) - Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- 72h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: standard ophthalmoscope - Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 0.1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 0.1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritant / corrosive response data:
- Moderate conjunctival irritation was noted in all treated eyes at the 1-hour observation. Moderate conjunctival irritation was noted in one treated eye at the 24-hour observation with minimal conjunctiva! irritation at the 48-hour observation. Diffuse corneal opacity was noted in one treated eye at the 24-hour observation. No other corneal effects were noted. lridial inflammation was noted in one treated eye at the 1 and 24-hour observations. No other iridial effects were noted.
- Other effects:
- Yellow-coloured staining of the fur around the treated eye was noted in all animals throughout the study.
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Mild irritation responses were reported well below the threshold for classification.
- Executive summary:
A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 405. A single application of the test material to the non-irrigated eye of three rabbits produced diffuse corneal opacity, iridial inflammation and moderate conjunctiva! irritation. No ocular effects were noted at the 72-hour observation. The test material produced a maximum group mean score of 11 .0 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The test material did not meet the criteria for classification as irritant according to EU labelling regulations.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
A GLP-compliant study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit (Safepharm, 2000). The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404. A single 4-hour, semi-occluded application of 0.5g of the test material (moistened with water) to the intact skin of three rabbits produced no evidence of skin irritation. The test material produced a primary irritation index of 0.0 and was classified as nonirritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
In a supporting non-GLP study the test substance was applied as paste (0.5 g test substance with 0.5 ml water) under occlusive conditions to the intact or scarified flank of six rabbits (Institut Francais de Recerches et Essais Biologiques, 1979). After 24 hours the patches were removed. One hour later the dermal reactions were evaluated and 48 hours later, a second reading was made to determine the extent of any recovery (the two readings were performed respectively 25 and 72 hours after the application of the substance). On the 7th day another reading was made. All scores measured at any time point for erythma and edema were zero for all animals. Based on the results of this study, the test substance was considered to be not irritating.
Eye irritation
A GLP-compliant study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit (Safepharm, 2000). The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 405. A single application of the test material (ca. 0.5 ml) to the non-irrigated eye of three rabbits produced moderate conjunctival irritation in all treated eyes at the 1-hour observation. Moderate conjunctival irritation was noted in one treated eye at the 24 -hour observation with minimal conjunctival irritation at the 48-hour observation. Diffuse corneal opacity was noted in one treated eye at the 24-hour observation. No other corneal effects were noted. lridial inflammation was noted in one treated eye at the 1 and 24-hour observations. No other iridial effects were noted. No ocular effects were noted in all treated eyes at the 72-hour observation. The reported ocular effects were mild and well below the regulatory threshold, therefore the test article is considered to not irritating to the rabbit eye.
In supporting non-GLP study, 100 mg of the test substance was applied undiluted into the conjunctival sac of the right eye of six rabbis (Institut Francais de Recerches et Essais Biologiques, 1979). The eyelids were held closed for several seconds, moved gently up and down and avoiding loss of test substance. The left eyes remained untreated and served as controls. Ocular reactions were recorded after 1 hour, 1 day, 2 days, 3 days, 4 days and 7 days. Minimal signs of irritation involving conjunctiva, cornea and iris below the regulatory threshold were observed at the 1 hour time point. The reactions were getting weaker starting at the 24 hour mark and were reversed to normal after 72 hours. Based on the results of this study, the test article was considered to be not irritating to the rabbit eyes.
Justification for selection of skin irritation / corrosion endpoint:
GLP-compliant guideline study
Justification for selection of eye irritation endpoint:
GLP-compliant guideline study
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the data, classification for irritation is not warranted under Directive 67/548/EEC.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification for irritation is not warranted under Regulation (EC) No.1272/2008.
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