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EC number: 479-930-8 | CAS number: 613222-52-9
- 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
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- 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:
- 2005-06-27 to 2005-09-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 479-930-8
- EC Name:
- -
- Cas Number:
- 613222-52-9
- Molecular formula:
- C40H76N2O4
- IUPAC Name:
- (3E)-3-({6-[(E)-[3-(dodecanoyloxy)-2,2-dimethylpropylidene]amino]hexyl}imino)-2,2-dimethylpropyl dodecanoate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ferenc Sandor Breeder, 2173 Kartal, Vörös Hadsereg Street 131, Hungary
- Age at study initiation: 11 weeks
- Weight at study initiation: 2918 - 3157 g
- Housing: individually in metal cages
- Diet: PURISTAR Standard Diet for Rabbits; AGRIBRANDS Europe Hungary PLC, H5300 Karcag, Madarasi road; Hungary; ad libitum
- Water: tap water ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity: 30 - 70 % R.H.
- Air changes: 8 - 12 air changes/hr by central air-condition system
- Photoperiod: 12 hrs dailiy from 6.00 a.m. to 6.00 p.m.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated skin of each animal served as control.
- Amount / concentration applied:
- 0.5 mL of test item applied in a single dose;
- Duration of treatment / exposure:
- 4 hours;
- Observation period:
- 1 hour, 24, 48 and 72 hours
- Number of animals:
- 3 animals
- Details on study design:
- TEST SITE
- Area of exposure: approximately 6 cm²
- Type of wrap if used: plastic wrap
OBSERVATION TIME POINTS
- 1 hour, 24, 48 and 72 hours
SCORING SYSTEM:
- Method of calculation: according to guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 11368/M
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 11325/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 11389/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 11368/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- 11325/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- One hour after the patch removal, one animal (no. 11368) developed very slight erythema on the treated skin surface (score 1). The other two animals (No. 11325, 11389) developed no primary irritation symptoms, such as erythema and oedema, or other adverse effects during the observation period, either at the treatment or the control application areas.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item SIKA Hardener LH is not considered to be irritant to rabbits' skin.
- Executive summary:
Sika Hardener LH (VP) was tested for skin irritation properties in a study with albino New Zealand White rabbits. The test material was applied to the intact skin of rabbits as a single dose of 0.5 mL. The irritation symptoms were examined at 1, 24, 48 and 72 hours after the patch removal. In one animal, very slight erythema were recorded 24 and 48 hours after patch removal (score 1), on the treated skin surface. All animals were free of irritation symptoms (erythema and oedeme) 72 hours after patch removal. Thus, the study was terminated after 72 hours.
The animals' individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema and oedema were 0.66. 0.00 and 0.00 and 0.00, 0.00 and 0.00 respectively. The observed symptoms were evaluated as fully reversible alterations.
No skin irritation properties were found in the test with Sika Hardener LH.
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