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EC number: - | 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:
- July 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD, EPA, etc)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): XP-7866
- Substance type: White powder
- Physical state: Solid
- Analytical purity: 99.5 wt% obtained by H-NMR
- Purity test date: 99.5 wt%
- Lot/batch No.: 10188-1 JM
- Expiration date of the lot/batch: February 28, 2015
- Storage condition of test material: Room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- EST ANIMALS
- Source: New Zealand White (Hsdlf:NZW) strain rabbits, supplied by Harlan Laboratories UK Ltd., Leicestershire, UK.
- Age at study initiation: twelve to twenty weeks old at the start of the study.
- Weight at study initiation: 2.21 to 3.08 kg at the start of the study.
- Housing: Animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70%
- Rate of air changes (per hr): Fifteen changes per hours
- Photoperiod (hrs dark / hrs light): 12h/12h light/darkness (0.6:00 to 18:00)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Left eye untreated
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A volume of 0.1 ml of the test item, which was found to weigh approximately 70 mg (as measured by gently compacting the required volume into an adapted syringe).
Note:
* The absorption of the test item was not determined.
*The pH of the test item was determined prior to commencement of the study. the pH was for a preparation of 10% w/w aqueous preparation of the test item: 7.3 immediately and 7.6 after 10 minutes. - Duration of treatment / exposure:
- single application to the test item to the non-irrigated eye.
- Observation period (in vivo):
- Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following the treatment.
- Number of animals or in vitro replicates:
- Three rabbits
- Details on study design:
- TEST APPLICATION:
Initially, a single rabbit was treated. The test item was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the
test item, and then released. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done
SCORING SYSTEM:
* Initial pain reaction:
Class 0: No response --> No initial pain
Class 1: A few blinks only, normal within one or two minutes --> Practically no initial pain
Class 2: Rabbit blinks and tries to open eye, but --> Slight initial pain
Class 3: Rabbit holds eye shut and puts pressure on lids, may rub eye with paw --> Moderate initial pain
Class 4: Rabbit holds eye shut vigorously, may squeal --> Severe initial pain
Class 5: Rabbit holds eye shut vigorously, may squeal, claw at eye, jump and try to escape --> Very severe initial pain
* Acute eye irritation in the rabbit:
Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49
TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- Degree of opacity
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable in this case
- Irritation parameter:
- cornea opacity score
- Remarks:
- Degree of opacity
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable in this case
- Irritation parameter:
- cornea opacity score
- Remarks:
- Degree of opacity
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable in this case
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable in this case
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable in this case
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable in this case
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks:
- after 72 hours
- Remarks on result:
- other: The score after 1 hour was 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks:
- after 72 hours
- Remarks on result:
- other: The score after 1 hour was 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks:
- after 72 hours
- Remarks on result:
- other: The score after 1 hour was 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks:
- after 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks:
- after 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks:
- after 48 hours
- Irritant / corrosive response data:
- According the experiment, the test item appears sightly irritant to eye but no effect after 72 hours observation.
- Other effects:
- No systemic effect observed based on bodyweight results.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Regarding the results of the experiment, the test item appears sightly irritant to rabbit eye but not sufficiently irritant for classification according to the criteria fixed by the EUROPEAN REGULATION (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
- Executive summary:
Introduction.
The study was performed to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit. The method was designed to be compatible with the following:
• DECO Guidelines for the Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 April 2002)
• Method 85 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008
Result.
A single application of the test item to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. All treated eyes appeared normal at the 72-Hour observation.
Conclusion.
Regarding the results of the experiment, the test item appears sightly irritant to rabbit eye but not sufficiently irritant for classification according to the criteria fixed by the EUROPEAN REGULATION (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
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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