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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:
- November 2013 - February 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (2012)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- (1998)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): EXP1200078
- Physical state: dark brown viscous liquid
- Storage condition of test material: at room temperature in the dark
- Analytical purity: 100%
- Lot/batch No.: E00275-350
- Expiration date of the lot/batch:End-2015
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: Covance Research Products, Inc., Greenfield, IN, USA
- Age at study initiation: Animals used within the study were approx 9 months old.
- Weight at study initiation: Body weights were 3321-3459 g.
- Housing: Individually housed in stainless steel cages.
- Diet: The basal diet for rabbits (PMI Nutrition International, LLC, Certified Rabbit HF LabDiet® 5325)was provided at approx 150 g/day.
- Water: Free access to tap water.
- Acclimation period: At least 5days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5-18.7
- Humidity (%): 45.4-53.1
- Air changes (per hr): approx 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: One eye of each animal remained untreated and served as the reference control.
- Amount / concentration applied:
- TEST MATERIAL- Amount applied: 0.1 mL (liquid)
- Duration of treatment / exposure:
- Single instillation on Day 1.
- Observation period (in vivo):
- The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after dosing, and on days 4, 7, 10 if irritation persisted.
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- TREATMENT
Approximately 60 minutes prior to test substance application, buprenorphine (0.01 mg/kg) was administered by subcutaneous injection (SC) to provide a therapeutic level of systemic analgesia.
Approximately 5 minutes prior to test substance application, one drop of a topical ocular anesthetic (0.5% proparacaine hydrochloride) was applied to each eye. The test substance (0.1 mL) was placed directly into the cupped lower conjunctival sac of each rabbit’s right (test) eye. The eyelid was held closed for approximately 1 second after instillation and then released. The left eye of each animal was manipulated in an identical manner to simulate the dosing of the right eye. Following test substance administration, no additional topical anesthetics were applied in order to avoid interference with the study.
Initially, a single animal was dosed. Based on the results 2 additional rabbits were exposed.
Approximately 8 hours after test substance administration, buprenorphine (0.01 mg/kg) SC and meloxicam (0.5 mg/kg) SC were administered to provide a continued therapeutic level of systemic analgesia. Following the initial 8-hour post-dosing treatment, buprenorphine (0.01 mg/kg) SC was administered every twelve (12) hours, in conjunction with meloxicam (0.5 mg/kg) SC every 24 hours, until positive ocular lesions/irritation resolved and no clinical signs of pain and distress were detected.
REMOVAL OF TEST SUBSTANCE
-Washing: No
OBSERVATIONS (beschrijf beperkt)
- Mortality/Viability: Twice daily.
- Toxicity: At least once daily.
- Body Weight: Obtained on study day 0 (initiation) and at each rabbit’s termination from the study (study day 7 or 10).
- Necropsy: the rabbits were euthanized by intravenous injection of sodium pentobarbital and discarded.
- Irritation: prior to initiation of dosing. The pre-initiation examination included the use of sodium fluorescein and a direct ophthalmoscope for detection of corneal abnormalities. Only rabbits with no pre existing ocular abnormalities were assigned to study. Both eyes of all rabbits were examined macroscopically for ocular irritation in accordance with the method of Draize at approximately 1, 24, 48 and 72 hours, and days 4, 7, 10 after instillation of the test substance when irritation persisted. The irritation scores and a description of all other (local) effects were recorded.The irritation was assessed according to OECD 405.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritant / corrosive response data:
- Conjunctival irritation was noted for all 3 rabbits. The only grade 2 finding was observed for one male at 24 hours post-dosing. All other conjunctival irritation was graded as 1 and subsided by study day 10.
The left (control) eyes were free of evidence of ocular irritation and other findings for the duration of the study. - Other effects:
- One animal had light brown staining of hair surrounding the eye. The other 2 animals had dried light brown material around eye.
There were no deaths during the study, nor test substane related clinical observations.
There were no remarkable body weight changes noted during the study. One rabbit had a very slight body weight loss (0.8%) from study days 0 to 7. However, body weight losses are commonly associated with animals that are on a restricted diet and can be enhanced by the use of systemic analgesics.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In an eye irritation study with rabbits, performed according to OECD test guidelines, slight irritation was observed, which disappeared by day 10.
- Executive summary:
In an eye irritation study with rabbits, performed according to OECD and OPPTS test guidelines, the eyes of 3 rabbits were exposed to 0.1 mL of the test substance. Conjunctival irritation was noted for all 3 rabbits. The only grade 2 finding was observed for one male at 24 hours post-dosing. All other conjunctival irritation was graded as 1 and subsided by day 10. Therefore, the substance is considered to be not an irritant for the eyes.
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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