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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006-11-09 to 2007-04-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and EU Method B.4 (Acute Toxicity: Dermal 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- The testing facility indicated that the protocol was followed without deviation.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal 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 from 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: obtained from Harlan UK Ltd, Bicester, Oxon, England
- Age at study initiation: approximately 34 weeks of age, prior to treatment (Day 1)
- Weight at study initiation: 3.19 – 4.41 kg
- Housing: housed individually in plastic cages with perforated floors
- Diet: offered 125 g of a standard laboratory rabbit diet (Rabbit Diet Pellets (Teklad) supplied by Harlan UK Ltd.) per day
- Water: provided ad libitum
- Acclimation period: at least fourteen 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: 2006-11-28 to 2006-12-19
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- abraded
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): no data
VEHICLE
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): The treatment site was ‘wetted’ with 0.5mL of reverse osmosis water.
- Lot/batch no. (if required): no data
- Purity: no data - Duration of treatment / exposure:
- single four hour dermal administration
- Observation period:
- Examination of the treated skin was made on removal of the dressings (for 3 minute or one hour exposures) and approximately 1, 24, 48 and 72 hours later.
- Number of animals:
- three
- Details on study design:
- TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: no data
- Type of wrap if used: approximately 0.5 g of the test substance was applied under a 2-ply 25 mm x 25 mm porous gauze pad secured with ‘blenderm’ surgical tape to intact skin sites on three animals.
REMOVAL OF TEST SUBSTANCE
- Washing: animals were washed with lukewarm water (30-40 deg C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
- Time after start of exposure: after 3 minutes or one hour exposures.
SCORING SYSTEM
- At 1, 24, 48 and 72 hours, erythema/eschar, oedema and the Primary Irritation Index (PII) and Classification were scored according to the Draize.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: Means of scores at approximately 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: Means of scores at approximately 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: Means of scores at approximately 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: Means of scores at approximately 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: Means of scores at approximately 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: Means of scores at approximately 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- other: non-irritant
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #2
- Time point:
- other: 1, 48 and 72 hours
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- other: non-irritant
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #2
- Time point:
- other: 24
- Score:
- 1
- Max. score:
- 8
- Remarks on result:
- other: mildly irritating
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- other: non-irritant
- Irritant / corrosive response data:
- A single case of very slight erythema was apparent 24 hours after bandage removal; no other sign was apparent at any treatment site at any time during the study period.
- Other effects:
- There was no sign of toxicity or ill health in any rabbit during the observation period.
Applicant's summary and conclusion
- Conclusions:
- The Primary Irritation Index was calculated to be 0.1; VRT-126016 was classified as ‘mildly irritating’ according to the criteria of the ECETOC and did not require labelling with the risk phrase R38, “Irritating to skin,” in accordance with Commission Directive 2001/59/EC.
- Executive summary:
Not applicable
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