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EC number: 478-210-0 | CAS number: 69901-75-3
- 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:
- 2006/12/18 - 2007/05/29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to OECD Guideline 405 (Acute Eye Irritation / Corrosion) and EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion) without deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- The testing facility indicated that the protocol was followed without deviation.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- The testing facility indicated that the protocol was followed without deviation.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate given by the Department of Health of the Government of the United Kingdom
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): VRT-126016
- Molecular formula: not applicable
- Molecular weight: not applicable
- Smiles notation: not applicable
- InChl: not applicable
- Structural formula attached as image file: not applicable
- Substance type: no data
- Physical state: white powder
- Analytical purity: 99.8 area %
- Impurities: 0.03 area % of unknowns
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: 2006-09-15
- Lot/batch No.: Batch number 0000025719/Lot No. 1-4107-6-02-02
- Expiration date of the lot/batch: 2008-02
- Stability under test conditions: no data
- Storage condition of test material: room temperature
- Other: no data
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: obtained from Highgate Farm, Market Rasen, Lincolnshire, England
- Age at study initiation: approximately 35 weeks of age, prior to treatment (Day 1)
- Weight at study initiation: 3.52 - 4.96 kg
- Housing: The rabbits were housed individually in plastic cages with perforated floors.
- Diet: Each rabbit was offered 125 g of a standard laboratory rabbit diet (Rabbit GD Diet Pellets supplied by Highgate Farm) per day. A dietary supplement of hay was offered during acclimation until two days prior to dose instillation. For the remainder of acclimation and throughout the study observation period, whole-meal bread was offered.
- Water: Drinking water was provided ad libitum.
- Acclimation period: for at least ten weeks prior to the start of the study
ENVIRONMENTAL CONDITIONS
- Temperature (deg C): 16 to 20 deg C
- Humidity (%): 40 to 70%
- Air changes (per hr): not applicable
- Photoperiod (hrs dark / hrs light): Lighting was controlled by means of a time switch to give 12 hours of artificial light (06:00 to 18:00 GMT) in each 24 hour period.
IN-LIFE DATES
- From: 2006-12-18 to 2007-01-18
Test system
- Vehicle:
- not specified
- Controls:
- other: The untreated eye was used as a comparison with the treated eye during assessment of ocular lesions.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): administered a single ocular dose of a volume of 0.1 mL of the test substance weighing approximately 64 mg
- The specific gravity of the test substance was approximated and the weight of VRT-126016 that occupied 0.1mL was determined. Aliquots of this weight were prepared. - Duration of treatment / exposure:
- Single ocular dose
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- three rabbits
- Details on study design:
- TREATMENT PROCEDURE
- The eyes of each animal were examined prior to instillation of the test substance, to ensure that there was no pre-existing corneal damage, iridial inflammation or conjunctival irritation. Each animal was gently restrained. The dose was instilled into the right eye by pulling the lower eyelid away from the eye ball to form a cup into which the test substance was dropped. The eyelids were then gently held together for one second before releasing; the left eye remained untreated.
SCORING SYSTEM
- Eye irritation scoring was performed according to Draize and is described in the Table for "Grading of Ocular Lesions" in OECD guideline 405.
TOOL USED TO ASSESS SCORE
An ophthalmoscope and a pencil beam torch were used to facilitate inspection of the eyes.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 10
- Max. score:
- 110
- Remarks on result:
- other: Minimally irritating
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 8.7
- Max. score:
- 110
- Remarks on result:
- other: Minimally irritating
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 5.3
- Max. score:
- 110
- Remarks on result:
- other: Minimally irritating
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 2.7
- Max. score:
- 110
- Remarks on result:
- other: Minimally irritating
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 8 days
- Score:
- 0
- Max. score:
- 110
- Remarks on result:
- other: Non-irritating
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: means scores over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: observation of corneal opacity
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: means scores over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: observation of iridial lesions
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: means scores over 24, 48 and 72 hours
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: observation of conjunctival redness
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: means scores over 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: observation of conjunctival chemosis
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: means scores over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: observation of corneal opacity
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean scores over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: observation of iridial lesions
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean scores over 24, 48 and 72 hours
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: observation of conjunctival redness
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean scores over 24, 48 and 72 hours
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: observation of conjunctival chemosis
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean scores over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: observation of corneal opacity
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean scores over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: observation of iridial lesions
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean scores over 24, 48 and 72 hours
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: observation of conjunctival redness
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean scores over 24, 48 and 72 hours
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: observation of conjunctival chemosis
- Irritant / corrosive response data:
- Injection of the conjunctival blood vessels or a crimson-red conjunctival appearance was apparent in all animals throughout the first 72 hours after instillation; very slight or slight chemosis was observed during this period, and slight or moderate discharge was evident during the first forty-eight hours after instillation.
Instillation of the test substance gave rise to a slight initial pain response. - Other effects:
- There was no sign of toxicity or ill health in any rabbit during the observation period.
Any other information on results incl. tables
Not applicable
Applicant's summary and conclusion
- Conclusions:
- Instillation of VRT-126016 gave rise to a “minimally irritating” response and the test substance did not require labelling with the risk phrase R36, “Irritating to eyes,” in accordance with Commission Directive 2001/59/EC.
- Executive summary:
Not applicable
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