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EC number: 813-928-3 | CAS number: 155810-87-0
- 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:
- 21.06. - 04.09.1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study, GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- NOTOX B.V., Hambakenwetering 7, 5231 DD ‘s-Hertogenbosch, The Netherlands
Test material
- Reference substance name:
- -
- EC Number:
- 431-770-1
- EC Name:
- -
- Cas Number:
- 216698-07-6
- Molecular formula:
- C32 H44 O4
- IUPAC Name:
- 2-(2-oxo-5-(1,1,3,3-tetramethylbutyl)-2,3-dihydro-1-benzofuran-3-yl)-4-(1,1,3,3-tetramethylbutyl)phenyl acetate
- Details on test material:
- - Physical state: White solid
- Analytical purity: 98.7%
- Stability under test conditions: stable
- Storage condition of test material: At room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Nederland, The Netherlands.
- Age at study initiation: at least 6 weeks old.
- Weight at study initiation: less than 3.5 kg
- Housing: Individually housed in labelled cages with perforated floors (Scanbur, Denmark) and equipped with an automatic drinking system (ITL, Bergen, The Netherlands)
- Diet: Standard laboratory rabbit diet, ad libitum (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany)
- Water: Free access to tap-water
- Acclimation period: at least 5 days before start of treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- water
- Controls:
- other: adjacent untreated areas served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 4 hrs
- Observation period:
- 3 days. skin reactions were assessed 1, 24, 48 and 72 hrs after the removal of the dressings
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm2).Each animal was treated by dermal application of 0.5 gram of the moistened test substance to the skin of one flank, using a Metalline patch of 2x3 cm. The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: The skin was cleaned of residual test substance using water
- Time after start of exposure: 4 hrs
SCORING SYSTEM:
The exposed skin areas were examined for signs of erythema and edema and the responses were scored (according to the grading system given in the OECD guideline 404) approximately 1 hr, and 24, 48 and 72 hours after removal of the patches.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: mean (24+48+72h)
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: mean (24+48+72h)
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No skin irritation and no corrosion was caused by 4 hours of exposure to the test article. All scores were zero at any time point.
- Other effects:
- No staining of the treated skin by the test substance was observed. No symptoms of systemic toxicity were observed in the animals during the test
period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- The test article did not cause any signs of irritation when applied semiocclusively for 4 hours to the rabbit skin.
- Executive summary:
In a primary skin irritation/corrosion study following OECD guideline 404 and in compliance with GLP, three rabbits were exposed to 0.5 gram of the test substance for four hours. The test substance was moistened with water and then applied onto clipped skin using a semi-occlusive dressing. After 4 hours the dressing was removed and the skin was cleaned of residual test substance using water. Observations were made 1, 24, 48 and 72 hours after exposure. No skin irritation was caused by 4 hours of exposure to the test article. All scores for edema and erythema were zero at any time point. Based on the results and according to the EC criteria for classification and labeling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), the test article is regarded as non-irritating to the rabbit skin and does not have to be classified.
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