Registration Dossier
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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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 2013-01-28 to 2013-02-23
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: According to ECHA Practical Guide 6 the maximum score for read across is rel. 2
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- 1998
- GLP compliance:
- yes
Test material
- Test material form:
- liquid: viscous
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Source: LPT, Laboratory of Pharmacology and Toxicology, Löhndorf (Germany)
- Sex: female
- Age: approx. 4.5 to 5.5 months
- Weight at study initiation: 2.4 kg up to 2.7 kg
- Housing: single
- Diet: ad libitum, ssniff K-H (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water: ad libitum, tap water
- Acclimatisation period: at least 20 days
- Controls: identical animal, second eye
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3 °C
- Humidity (%): 30% - 70%
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: identical animal, left eye
- Amount / concentration applied:
- Amount: 0.1 mL of the test item was administered per eye
- Duration of treatment / exposure:
- Single instillation into the conjunctival sac of the right eye, test item was not rinsed
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 female rabbits
- Details on study design:
- ADMINISTRATION: The test was performed initially using one animal. As no corrosive or severe irritant effects were observed in this animal, 2 further
animals were employed 24 hours after start of the initial test.
0.1 mL of the test item was administered per eye and tested in three animals.
The test item was placed into the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were
then gently held together for about one second in order to prevent loss of the material. The left eye, which remained untreated, served as a control.
REMOVAL OF TEST SUBSTANCE
- Washing: test item was not rinsed
TOOL USED TO ASSESS SCORE: eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48 and 72 hours after the administration. The eye reactions were observed and registered.
At 24 hours after the administration, the eyes were treated additionally with fluorescein and examined.
SCORING SYSTEM: Draize scale
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- AVERAGE SCORE
- Cornea: 0
- Iris: 0
- Conjunctivae (Redness): 0
- Conjunctivae (Chemosis): 0 - Other effects:
- no other effects
Any other information on results incl. tables
Acute eye irritation/corrosion test of the test item
Examination of the treated eye
Time after administration |
C O R N E A |
I R I S |
C O N J U N C T I V A E |
|
|
Opacity |
|
Redness# |
Chemosis## |
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A n i m a l n o. : 1 / 2 / 3 |
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right eye: 100 ml test item |
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before dosing |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
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|
1 hour |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
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24 hours |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
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|
48 hours |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
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|
72 hours |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
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Applicant's summary and conclusion
- Conclusions:
- The test substance was n o n - i r r i t a t i n g to eyes, hence, no labelling is required.
- Executive summary:
The purpose of this study was to obtain information on the influence of the test item on rabbit eyes (irritation/corrosion test), according to OECD guideline 405, EC method B.5. and OCSPP guideline 870.2400.
Under the present test conditions a single administration of the test item per animal into the conjunctival sac of the right eye of three rabbits did not cause any changes.
Conjunctival redness, corneaeandirises were not affected by instillation of the test item. There were no systemic intolerance reactions.Therefore, according to the EC Regulatiom 1272/2008 and subsequent regulations on classification, labelling and packaging of substances and mixtures, the test item is non-irritating to eyes, hence, no labelling is required.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

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