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Diss Factsheets
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EC number: 214-192-0 | CAS number: 1112-55-6
- 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
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Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2019-06-03 to 2019-06-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2015
- Deviations:
- yes
- Remarks:
- Housing room temperature and humidity has small deviations from Guideline, but not affect the quality and integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Tetravinylsilane
- EC Number:
- 214-192-0
- EC Name:
- Tetravinylsilane
- Cas Number:
- 1112-55-6
- Molecular formula:
- C8H12Si
- IUPAC Name:
- tetraethenylsilane
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Japanese white
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Shenyang Tenghua Biotechnology Co., Ltd.
- Age at study initiation: 97-108 days
- Weight at study initiation: 2344.6-2407.8 g
- Housing: individually raised in suspended, stainless steel cages (W 40 cm× L50 cm×H40 cm) on cage racks (L167 cm×W70cm×H171 cm)
- Diet: pellet rabbit diet, ad libitum
- Water: ad libitum
- Acclimation period: 7-8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4-25.1
- Humidity (%): 49-77
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 mL test item
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- Initial Test: 1
Confirmatory Test: 2 - Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm× 2.5 cm
- Dosing: A dose 0.5 mL of the test item was applied to the gauze patch (2.5 cm × 2.5 cm). The test and control patches were applied to the appointed and depilated skin.
- Type of wrap: All animals were wrapped using elastic bandage and medical paper tape to form a semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing: Patches were removed at the end of the exposure period. The residual test substance was gently wiped off the application site by cotton moistened with tepid water. Care was taken not to alter the existing response or the integrity of the epidermis.
- Time after start of exposure: 4h
OBSERVATION TIME POINTS
- Clinical Observations:
All animals were observed for clinical signs once daily throughout the study.
- Skin Reactions Examination:
The skin sites of each animal were examined and recorded for signs of skin reaction immediately, at approximately 1, 24, 48 and 72 hours after patch removal.
- Body Weights:
Individual animal body weights were recorded within 24 hours after arrival, on the day of dosing and on the completion day of the final observation of dermal irritant symptoms.
SCORING SYSTEM:
- Method of calculation: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2 & #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2 & #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- The test item sites did not show any evidence of adverse skin reactions such as erythema and oedema immediately, at approximately 1, 24, 48 and 72 hours after patch removal of the test item.
There was no observable abnormality in skin reaction examinations for three control sites at all observation intervals after patch removal of the test item. - Other effects:
- - Clinical Observations:
No abnormal signs or symptoms were observed in three animals throughout the course of the study.
- Body Weights:
The body weights of all animals showed growth trends during the observation periods.
Any other information on results incl. tables
Skin Reactions Grading:
No. |
Erythema |
Oedema |
||||||
24h |
48h |
72 h |
Mean |
24h |
48h |
72 h |
Mean |
|
1100 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1101 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1102 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was considered to not be irritating to skins in rabbits.
- Executive summary:
The study was performed to assess the acute dermal irritation/corrosion of test item in rabbits in accordance with OECD 404.
Three male rabbits were used for the study. 0.5 mL of test item was applied to the right side of back skin of each animal for an exposure period of 4 hours. The untreated skin on the left back area of the animal served as the control.
No abnormal signs or symptoms were observed in three animals throughout the course of the study.
The body weights of all animals showed growth trends during the observation periods.
Individual scores of erythema/eschar and oedemas were all 0 for three treated sites at 1, 24, 48 and 72 hours after patch removal. The mean scores of erythema/escharand oedemasat24,48 and 72 hourswereall0 for threetestsitesafter patch removal.
The test item was considered to not be irritating to skins in rabbits.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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