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Diss Factsheets
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EC number: 939-180-9 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 Jun 2000- Nov 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The experiment was conducted according to current EC/OECD guidelines in compliance with GLP standards.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- IONAC XAMA®220
- IUPAC Name:
- IONAC XAMA®220
- Details on test material:
- - Substance type: Clear colorless liquid
- Expiration date of the lot/batch: not described
- Storage condition of test material: room temperature
- Receipt date of batch: June 22, 2000
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Myrtle's rabbitry, Thompson Station, TN
- Age at study initiation: appr. 15 weeks
- Weight at study initiation: 2.9-3.5kg (m)/ 2.8-3.5kg (f)
- Housing: individually, in suspended stainless steel cages
- Diet: ad libitum, PMI Certified Rabbit Chow #5322 (Purina Mills, Inc.)
- Water: ad libitum, purified tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-21
- Humidity (%): 42-80
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: July 10, 2000 To: July 31, 2000
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the contralateral eye remained untreated
- Amount / concentration applied:
- 0.1ml
- Duration of treatment / exposure:
- Single instillation
- Observation period (in vivo):
- 1, 24, 48, 72 hours and up to 7 days
- Number of animals or in vitro replicates:
- 3 males, 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no. In addition to the 6 rabbits whose eyes were not rinsed, 3 females were treated with 0.1ml of the test substance and subsequently the eyes were rinsed (30s after instillation) with sterile water. These animals were observed up to 21 days.
SCORING SYSTEM:
Ocular grading system according to Draize; details described in OECD guideline
OBSERVATIONS:
- General health and mortality was monitored twice daily.
TOOL USED TO ASSESS SCORE: lamp / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- ca. 3.4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: 2/6 rabbits had severe swelling that hampered ocular inspection at 24 hours.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- ca. 1.1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: For none of the rabbits the iris score could be assessed at 24 hours due to severe swelling.
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 2.8
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 2.2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritant / corrosive response data:
- The eyes of animals with rinsed eyes were only exposed for 30s. The following scores were obtained (where possible, based on observations at 24, 48 and 72 hours):
Cornea: ca. 2.6 (one animal's eye too swollen at t=48 hours to be assessed)
Iris: ca. 1.2 (one animal's eye too swollen to be assessed)
Conjunctivae- redness: ca. 2.8
Chemosis: ca. 4
Conjunctivae- discharge: ca. 2.3
After 21 days, effects were not reversed. - Other effects:
- In the group of animals without rinsing of the eyes slight hairloss around the treated eye was observed in 2 males and 2 females. One male showed head tilt on days 0-2.
The three females whose eyes were rinsed also showed hairloss around the treated eye (slight to moderate). Two females showed head tilt on days 0-2.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- An eye irritation study according to current OECD/EC guidelines was conducted in compliance with GLP principles. Based on the results of this study, the substance has to be classified category 1 causing "irreversible effects on the eye/ serious damage to eyes" according to CLP Regulation (EC) No. 1272/2008.
- Executive summary:
An eye irritation study according to current OECD/EC guidelines was conducted in compliance with GLP principles. In this study, 6 rabbits (3 males and 3 females) showed severe effects on the eyes the first 72 hours after treatment, which did not reverse after one week. In parallel, three females were treated with the substance, which was removed from the eye after 30s by rinsing. The effects to the eyes of these animals were comparable to the eyes of the unrinsed group. The effects did not reverse within 21 days after treatment. Additionally, three treated animals (two with rinsed and one with unrinsed eyes) showed tilting of the head, Seven rabbits showed slight hairloss around the treated eye. Based on the results of this study, the substance has to be classified with category 1, H318, causing "irreversible effects on the eye/ causes serious eye damage" according to CLP Regulation (EC) No. 1272/2008.
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