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Diss Factsheets
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EC number: 611-631-1 | CAS number: 58190-57-1
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity: OECD 423. GLP study: The acute oral LD50 value of the test item EAC3 was found to be greater than 2500 mg/kg bw in female rats.
Acute dermal toxicity: Based on the read-across approach from experimental data on analogue acetone oxime (test method OECD 402, GLP study), acute dermal LD50 of EAC3 was determined to be greater than 2493.77 mg/kg bw in male and female rats.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 12, 2012 - November 29, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test method in accordance with OECD 423. GLP study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: CRL:(WI)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Age at study initiation: 10-11 weeks old
- Weight at study initiation: 230 – 240 g
- Fasting period before study: overnight
- Housing: 3 animals/cage, type II polypropylene/polycarbonate with lignocel bedding.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 19 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.9 – 22.5 °C
- Humidity (%): 37 – 69 %
- Air changes (per hr): 15 – 20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m. - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 250 mg/mL in the vehicle
- Amount of vehicle (if gavage): 10 mL/kg bw
- Lot/batch no. (if required): BCBH2687V
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: limit dose of 2500 mg/kg bw (requested by the sponsor). - Doses:
- 2500 mg/kg bw
- No. of animals per sex per dose:
- 6 animals, 3 animals/group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical observations were performed on all animals at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter.
The body weight was recorded on the day before treatment (Day -1), on the day of the treatment (Day 0) and weekly after
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other:
Individual observations were performed on the skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. At necropsy, after examination of the external appearance, the cranial, thoracic and the abdominal cavities were opened and the organs and the tissues were observed. - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- EAC3 did not cause mortality at a dose level of 2500 mg/kg bw.
- Clinical signs:
- other: Treatment with EAC3 at the dose level of 2500 mg/kg bw caused decreased activity (6/6), hunched back (6/6), prone position (4/6), incoordination (6/6), piloerection (5/6), creeping gait (3/6). All animals were symptom free from three days after the treatm
- Gross pathology:
- No macroscopic observations were present at a dose level of 2500 mg/kg bw.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 value of the test item EAC3 was found to be greater than 2500 mg/kg bw in female CRL:(WI) rats.
- Executive summary:
The single-dose oral toxicity of EAC3 was performed according to the acute toxic class method OECD 423 in CRL:(WI) rats. Two groups of three female rats were treated by gavage with the test item at a dose level of 2500 mg/kg bw. Initially, three females (Group 1) were treated and as no mortality was observed, a confirmatory group (Group 2) was treated at the same dose level. No mortality was observed in the confirmatory group, therefore no further testing was required according to OECD 423. Clinical observations were performed for 14 days and all animals were subjected to a necropsy and a marcroscopic examination. All animals were clinical symptom (decreased activity, huncled back, prone position, incoordination, piloerection and creeping gait) free from three days after the treatment. Body weight gains showed no indication of a test item-related effect. No macroscopic observations were present at a dose level of 2500 mg/kg bw. Under the conditions of this study, the acute oral LD50 value of the test item EAC3 was found to be greater than 2500 mg/kg bw in female CRL:(WI) rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 500 mg/kg bw
- Quality of whole database:
- The study is a GLP compliant and has Klimisch score 1. The quality of the database was determined as appropriate for assessment.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- EAC3 undergoes rapid hydrolysis in aqueous to acetone oxime and the corresponding ethylsilanetriol. Silanetriols undergo continuous condensation reactions to produce higher molecular weight siloxanes which are considered biologically unavailable. Therefore, the observed toxicity is likely due to the acetone oxime and their values are comparable.
- Principles of method if other than guideline:
- Read-across approach from experimental data (according to OECD Guideline 402 and GLP) on analogue substance acetone oxime.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 493.77 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: (read-across approach from an analogue)
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on experimental data on the analogue acetone oxime (test method according to OECD 402 and GLP), the read-across approach was applied and the acute dermal LD50 of the test item EAC3 was determined to be greater than 2493.77 mg/kg body weight in male and female rats.
- Executive summary:
An acute dermal toxicity study was performed with the analogue substance acetone oxime in CRL:(WI) rats, in compliance with OECD 402. A limit test was carried out at 2000 mg/kg body weight (bw) in both sexes (5 rats/sex). The test item was applied as supplied as a single dermal 24-hour exposure followed by a 14-day observation period. No effects were observed. The acute dermal LD50 of the analogue acetone oxime was found to be greater than 2000 mg/kg bw in male and female rats. Based on these results, the read-across approach was applied and the the acute dermal LD50 of EAC3 was determined to be greater than 2493.77 mg/kg bw in male and female rats.
Reference
See "Data Matrix" and "Reporting Format" attached.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 493.77 mg/kg bw
- Quality of whole database:
- The study on the analogue substance is a GLP compliant and has Klimisch score 2. The quality of the database was determined as appropriate for assessment.
Additional information
Acute oral toxicity:
Key study: An acute oral toxicity test was performed on EAC3 according to the acute toxic class method OECD 423 in CRL:(WI) rats. Two groups of three female rats were treated by gavage with the test item at a dose level of 2500 mg/kg bw. Under the conditions of this study, the acute oral LD50 value of the test item EAC3 was found to be greater than 2500 mg/kg bw in female CRL:(WI) rats.
Acute dermal toxicity:
Key study: Read-across from the analogue substance acetone oxime: An acute dermal toxicity study was performed with the analogue substance acetone oxime in CRL:(WI) rats, in compliance with OECD 402. A limit test was carried out at 2000 mg/kg body weight (bw) in both sexes (5 rats/sex). No effects were observed. The acute dermal LD50 of the analogue acetone oxime was found to be greater than 2000 mg/kg bw in male and female rats. Based on these results, the read-across approach was applied and the acute dermal LD50 of EAC3 was determined to be greater than 2493.77 mg/kg bw in male and female rats.
Acute inhalation toxicity:
Data waiving (other justification): According to REACH Annex VIII, column 2: In addition to the oral route, for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route need be provided. The information is provided for dermal route.
Justification for selection of acute toxicity – oral endpoint
Only one study available.
Justification for selection of acute toxicity – inhalation endpoint
Data waiving: According to REACH Annex VIII, column 2: In addition to the oral route, for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route need be provided. The information is provided for dermal route.
Justification for selection of acute toxicity – dermal endpoint
Only one study available.
Justification for classification or non-classification
Based on the available data on oral and dermal acute toxicity (LD50 > 2000 mg/kg bw), the substance 2 -propanone, 2,2',2''-[O,O',O''-(ethylsilylidyne)trioxime] (EAC) is not classified for acute toxicity according to CLP Regulation (EC) No 1272/2008.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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