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Diss Factsheets
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EC number: 478-200-6 | 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
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 2007-4-11
- 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 Irriation/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 deviations.
- 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 deviations.
- 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-126028
- Molecular formula (if other than submission substance): C14H23NO6
- Substance type: pure active substance
- Physical state: solid, white powder
- Analytical purity: 99.3% area by GC
- Purity test date: 2006-05-22
- Lot/batch No.: lot# WYJ11410404533/ batch 25414
- Expiration date of the lot/batch: 2008-05-01
- Storage condition of test material: room temperature
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Highgate Farm, Market Rasen, Lincolnshire, England
- Age at study initiation: 33-39 weeks
- Weight at study initiation: 4.59 – 4.68 kg
- Housing: housed individually in plastic cages with perforated floors
- Diet (e.g. ad libitum): Each rabbit was offered 125 g of a standard laboratory rabbit diet (Rabbit Diet Pellets (GD) supplied by Highgate Farm) per day in addition to a dietary supplement of hay.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (deg C): 16 to 20 deg C
- Humidity (%): 40 to 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours artificial light in each 24-hour period
IN-LIFE DATES: From: no data To: no data
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: An additional site on each treatment animal was similarly treated with the exception of test substance and acted as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of test substance
- Concentration (if solution): no data
VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable - Duration of treatment / exposure:
- Single 4 hour treatment
- Observation period:
- 72 hours (observations made at 24, 48, and 72 hours for skin reaction)
- Number of animals:
- three
- Details on study design:
- TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: no data
- Type of wrap if used: 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, covered with cotton wool and "Tubigrip" elasticated bandage dressing for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with lukewarm water (30-40 deg C) to remove any residual test substance and blotted dry with absorbent paper
- Time after start of exposure: 3 minutes, 1 hour, or 4 hours
SCORING SYSTEM:
A primary irritation index (PII) was calculated from the erythema and oedema scores according to the following formula as described in Technical Report No. 66 “Skin irritation and Corrosion: Reference chemicals data bank” (March 1995) ECETOC, Brussels. The maximum possible score was 8.0.
PII= (Σ Erythema at 24/48/72 hours + Σ Oedema at 24/48/72 hours)/(3 x number of animals)
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: Mean of scores at approximately 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: Not applicable
- Irritant / corrosive response data:
- No dermal irritation 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.
Any other information on results incl. tables
Not applicable
Applicant's summary and conclusion
- Conclusions:
- The Primary Irritation Index was calculated to be 0.0; the test substance was classified as ‘non-irritant’ 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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