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EC number: 445-890-5 | CAS number: 201290-01-9
- 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
- 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:
- 11 March 2003 to 26 March 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 445-890-5
- EC Name:
- -
- Cas Number:
- 201290-01-9
- Molecular formula:
- C14H37NO2Si3
- IUPAC Name:
- 7-ethoxy-2,2,7-trimethyl-3-(trimethylsilyl)-8-oxa-3-aza-2,7-disiladecane
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature in the dark
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: the test material was used undiluted
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test material was used undiluted. The absorption of the test material was not determined.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., UK
- Age at study initiation: 12 - 20 weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: individually housed in suspended metal cages
- Diet: Certified Rabbit Diet, ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 15/hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): the test material was applied undiluted
NEGATIVE CONTROL: not applicable
POSITIVE CONTROL: not applicable - Duration of treatment / exposure:
- Animal No. 1: 3 minutes, 1 hour and 4 hours
Animal No. 2 and 3: 4 hours - Observation period:
- 1 hour, 24, 48 and 72 hours after patch removal and an additional observation on day 7.
- Number of animals:
- 3 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: dorsal/ flank area
- % coverage: no data
- Type of wrap if used: the test material was introduced under 2.5 cm x 2.5 cm cotton gauze patch and secured in position with a strip of surgical adhesive tape. An elastic corset was used to prevent the animals interfering with the patches.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test material was removed by gentle swabbing with cotton wool soaked in a suitable solvent.
- Time after start of exposure: One rabbit was initially treated and three patches of test material were applied. One patch was removed at each of three time points: 3 minutes, 1 hour and 4 hours.
OBSERVATION TIME POINTS
One rabbit was initially treated and three patches of test material were applied on the dorsal area. One patch was removed at each of three time points: 3 minutes, 1 hour and 4 hours. After consideration of the skin reactions produced in the first animal, two additional animals were treated with 0.5 ml of test material. One patch was applied to the back of each rabbit and was allowed to remain in contact with the skin for 4 hours. The test sites were examined for primary irritation at 1 hour, 24, 48 and 72 hours after patch removal.
SCORING SYSTEM:
- Method of calculation: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.75
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Remarks:
- 1-hour exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- 1-hour exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- 3-minute exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- 3-minute exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- 4-hour exposure period: Well-defined erythema and very slight to slight oedema were noted at all treated skin sites one hour after patch removal and at the 24-hour observation period with very slight erythema and very slight oedema at all treated skin sites at the 48 and 72-hour observations. Loss of skin elasticity was noted at all treated skin sites at the 72-hour observations. All treated skin sites appeared normal on day 7.
1-hour exposure period: very slight erytheme and very slight oedema were noted at 1 hour after patch removal. Very slight erythema was still evident at 24 hours post-treatment. The treated skin site appeared normal at the 48-hour observation.
3-minute exposure period: Very slight erythema was noted at the treated skin site one hour after patch removal. All the treated skin sites appeared normal by 24 hours post-exposure.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the skin irritation study, conducted according to OECD TG 404 and in compliance with GLP, the test item, N,N-bis(trimethylsilyl)aminopropylmethyldiethoxysilane, was reported to be a mild irritant to rabbit skin, however it did not meet the criteria for classification according to GHS and Regulation (EC) No. 1272/2008.
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