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EC number: 289-124-6 | CAS number: 86014-76-8
- 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:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- November 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Royal Decree 363/1995, of 10 March
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: Royal Decree 1078/93 of 2 July
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- Similar Substance 01 - AB165
- IUPAC Name:
- Similar Substance 01 - AB165
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: authorized breeder.
- Weight at study initiation: 2001, 2453, 2607 g
- Housing: single housed in a stainless steel cage, brand Tecniplast.
- Diet: daily dose of 150 g special diet for rabbits experimental provided by an authorized provider.
- Water: filtered tap water, ad libitum.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2°C
- Humidity: 55 ± 25 %
- Air changes: 15 ACH with air filtered 5 µm.
- Photoperiod: 12 hour cycle dark/light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- moistened
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 24, 48, 72 hours, 7, 14 and 21 days
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 20 cm x 13 cm
- Coverage: 6 cm^2
- Type of wrap if used: Gauze type dressings (Melolin) or equivalent, Sticking plaster, hypoallergenic adhesive bandage (Fixomull Seretch) or equivalent.
REMOVAL OF TEST SUBSTANCE
- Washing: yes; after the exposure period the substance is gently removed with water or suitable solvent.
EVALUATION OF SKIN REACTIONS
Eschar formation
No erythema...................................................0
Very slight erythema (barely perceptible)......1
Well-defined erythema....................................2
Moderate to severe erythema.........................3
Severe erythema to slight eschar formation...4
Oedema formation
No oedema..............................................................................................................0
Very slight oedema (barely perceptible).................................................................1
Slight oedema (edges well-defined)........................................................................2
Moderate oedema (raised ca. 1 mm).......................................................................3
Severe oedema (raised more than 1 mm; extending beyond area of exposure)....4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- erythema score
- Basis:
- other: animal 2 and 3
- Time point:
- other: 24, 48, 72
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: shaved skin
- Other effects:
- In the three animals was observed a brown skin coloured into the application site. This effect persists after 21 days in the rabbit no. 1 and disappears after 14 days in the rabbits no. 2 and no. 3.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified, according to the Regulation EC 1272/2008 (CLP)
- Conclusions:
- The substance was tested for skin irritation following a guideline compareble to OECD 404. Under the experimental conditions the substance did not show any skin irritation properties.
- Executive summary:
The substance has been tested for skin irritation according to the procedure inside the Spain Royal Decree 363/1995 and Royal Decree1078/93 comparable to OECD 404.
Three male rabbits are tested with 0.5 g of test item to the shaved skin after 4 hours of patch treatment. The scores of each animal at the reading times of 24, 48 and 72 hours was used in calculating the respective mean values for each type of lesion. Under the experimental conditions the substance did not show any skin irritation properties.
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