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Diss Factsheets
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EC number: 202-525-2 | CAS number: 96-69-5
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 28 - April 4, 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Although the study was quite old and not performed under GLP conditions, the described study method was comparable to OECD Guideline 405.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- not under GLP conditions, study dates 1986
- GLP compliance:
- not specified
Test material
- Details on test material:
- - Name of test material (as cited in study report): Slz WX-R
- Analytical purity: 99.93%
- Lot/batch No.: 8623
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Japan Lab Animals Co., Ltd.
- Age at study initiation: not mentioned.
- Weight at study initiation: 2.05-2.47 kg
- Housing: individual metal mesh-bottomed suspenses cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 - 42 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 27
- Humidity (%): 45 - 75
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 1, 24, 48, 72, (96 hours, 1 week): with or without washing after 30 seconds for 1 minute
- Observation period (in vivo):
- 1, 24, 48, 72, (96 hours, 1 week)
- Number of animals or in vitro replicates:
- 3 with washing; 3 without washing
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, in one group
- Time after start of exposure: 30 seconds
SCORING SYSTEM: Criteria of Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- non-washed group
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- other: Score: 10.0, 6.7, 6.7, 1.7, 0 resp. at t = 24, 48, 72, 96 h, 1 week
- Irritation parameter:
- iris score
- Remarks:
- non-washed group
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 1.7
- Max. score:
- 5
- Reversibility:
- fully reversible within: 96 hours
- Remarks on result:
- other: Score: 5.0, 1.7, 1.7, 0, 0 resp. at t= 24, 48, 72, 96 h, 1 week
- Irritation parameter:
- conjunctivae score
- Remarks:
- non-washed group
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 6
- Max. score:
- 6
- Reversibility:
- fully reversible within: 96 hours
- Remarks on result:
- other: Score: 12.7, 4.0, 0.7, 0, 0 resp. at t = 24, 48, 72, 96 h, 1 week
- Irritation parameter:
- cornea opacity score
- Remarks:
- washed group
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Score: 0, 0, 0 resp. at t = 24, 48, 72 h
- Irritation parameter:
- iris score
- Remarks:
- washed group
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Score: 0, 0, 0 resp. at t = 24, 48, 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- washed group
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Score: 2.7, 0, 0 resp. at t = 24, 48, 72 h
- Irritant / corrosive response data:
- In the non-washed group (3 animals), all of the cases showed conjunctival redness with a strength level of 1 and conjunctival edema with a strength level of 2 at 1 hour after Slz WX-R application, while 1 case showed iris hyperemia with a strength level of 1. No change in the strength of the conjunctival hyperemia was observed at 24 hours after application, but in all of the cases, the strength of the conjunctival redness increased to a level of 2. Further, 2 cases newly developed iris hyperemia with a strength level of 1, and all of the cases showed corneal opacity with a strength level of 1 and a breadth of 1 to 4 as well as eye discharge with a strength level of 2 to 3. These local reactions gradually lessened, with only 1 case showing corneal opacity with a strength level of 1 and a breadth of 1 at 96 hours after application. After 1 week, all of the local reactions had disappeared. In the washed group (3 animals), all of the cases showed conjunctival redness and conjunctival edema with a strength level of 1 at 1 hour after Slz WX-R application. By 24 hours after application, the conjunctival redness had disappeared in 1 case, and the conjunctival edema also disappeared in 2 cases. However, 1 case newly developed eye discharge with a strength level of 1. All of these local reactions disappeared by 48 hours after application.
Based on the above-noted results, the mean total scores for the local reactions in each tissue were calculated. The maximum value up to 72 hours after application was 27.7 at 24 hours after application in the non-washed group and 4.0 at 1 hour after application in the washed group. These results indicated that Slz WX-R showed moderate irritation of rabbit eyes in the non-washed group, with only extremely mild irritation in the washed group, demonstrating the effects of washing. - Other effects:
- none
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A study in 3 rabbits revealed that Slz WX-R 6 was moderately irritanting when the eyes were not washed and extremely mild irritating when the eyes were washed after 30 seconds of exposure. The study was not performed according to the general guidelines for acute eye irritation/corrosion under GLP conditions, but was well performed and documented and as such considered reliable with minor restrictions.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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