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EC number: 433-360-6 | CAS number: 34036-80-1
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- 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:
- 2-butanone-O,O',O''- (phenylsilylidyne)trioxime undergoes rapid hydrolysis in aqueous to butanone oxime and the corresponding silanol. Silanetriols undergo continuous condensation reactions to produce higher molecular weight siloxanes which are considered biologically unavailable. Therefore, the observed toxicity is likely due to butanone oxime and their values are comparable.
- Reason / purpose for cross-reference:
- reference to other study
- Principles of method if other than guideline:
- Read-across approach from experimental data (test method according to EPA OTS 798.4700) on an analogue substance.
- GLP compliance:
- no
- Clinical signs:
- effects observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Other effects:
- not examined
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Dose descriptor:
- LOAEL
- Remarks:
- (parental toxicity)
- Effect level:
- 13.91 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks:
- (analogue substance)
- Sex:
- male/female
- Basis for effect level:
- other: (Based on read-across approach from analogue substance butanone oxime) (Basis for effect: hematopoiesis and hemosiderosis in spleens and livers of P and F1 males and females).
- Remarks on result:
- other: Generation: other: (P and F1) (migrated information)
- Dose descriptor:
- NOAEL
- Remarks:
- (reproductive and postnatal toxicity)
- Effect level:
- > 278.16 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks:
- (analogue substance)
- Sex:
- male/female
- Basis for effect level:
- other: (Based on read-across approach from analogue substance butanone oxime) (Basis for effect: no effects at highest dose tested).
- Remarks on result:
- other: Generation: (F1 and F2) (migrated information)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
- Reproductive effects observed:
- not specified
- Conclusions:
- Based on the read-across approach from experimental results on analogue butanone oxime, the LOAEL for parental toxicity for 2-butanone-O,O',O''- (phenylsilylidyne)trioxime in rats was estimated to be 13.91 mg/kg bw/day and the NOAEL for reproduction and postanatal toxicity was estimated to be > 278.16 mg/kg bw/day.
- Executive summary:
A two-generation study was performed on the analogue substance butanone oxime on CD (Sprague-Dawley) rats according to EPA OTS 798.4700 up to 200 mg/kg bw/day. Based on the experimental results on the analogue where adult toxicity was observed in both generations and both sexes at all doses (LOAEL for parental toxicity = 10 mg/kg bw/day, basis for effect: hematopoiesis and hemosiderosis in spleens and livers) and where no evidence of reproductive organ or mammary gland pathology or of reproductive or postnatal toxicity was observed at the highest dose (NOAEL for reprotox > 200 mg/kg bw/day), the read-across approach was applied and the LOAEL for parental toxicity for 2-butanone-O,O',O''- (phenylsilylidyne)trioxime in rats was estimated to be 13.91 mg/kg bw/day and the NOAEL for reproduction and postanatal toxicity was estimated to be > 278.16 mg/kg bw/day.
Reference
See "Data Matrix" and "Reporting Format" attached.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 278.16 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- One two-generation study is available on an analogue substance with a Klimisch score = 2. The overall quality of the database was determined as appropriate for assessment.
Additional information
Key study: Read-across from experimental results on analogue substance butanone oxime:
Key study: A two-generation study was performed on the analogue substance butanone oxime on CD (Sprague-Dawley) rats according to EPA OTS 798.4700 up to 200 mg/kg bw/day. Based on the experimental results on the analogue where adult toxicity was observed in both generations and both sexes at all doses (LOAEL for parental toxicity = 10 mg/kg bw/day, basis for effect: hematopoiesis and hemosiderosis in spleens and livers) and where no evidence of reproductive organ or mammary gland pathology or of reproductive or postnatal toxicity was observed at the highest dose (NOAEL for reprotox > 200 mg/kg bw/day), the read-across approach was applied and the LOAEL for parental toxicity for 2-butanone-O,O',O''- (phenylsilylidyne)trioxime in rats was estimated to be 13.91 mg/kg bw/day and the NOAEL for reproduction and postanatal toxicity was estimated to be > 278.16 mg/kg bw/day.
Short description of key information:
Key study: Based on the read-across approach from experimental data (Test method EPA OTS 798.4700) on analogue butanone oxime, the NOAEL for reproductive and postnatal toxicity for 2-butanone-O,O',O''- (phenylsilylidyne)trioxime in a two-generation study was estimated to be > 278.16 mg/kg/day for rats.
Justification for selection of Effect on fertility via oral route:
One two-generation study available (key study).
Effects on developmental toxicity
Description of key information
Key study: Based on the read-across approach from experimental results (Test method EPA OTS 798.4900) on analogue butanone oxime where no treatment-related gestational effects, malformations or developmental variations were observed, the NOAEL for developmental toxicity of 2-butanone-O,O',O''- (phenylsilylidyne)trioxime was determined to be > 834.48 mg/kg bw/day in rats.
Link to relevant study records
- Endpoint:
- developmental toxicity
- 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:
- 2-butanone-O,O',O''- (phenylsilylidyne)trioxime undergoes rapid hydrolysis in aqueous to butanone oxime and the corresponding silanol. Silanetriols undergo continuous condensation reactions to produce higher molecular weight siloxanes which are considered biologically unavailable. Therefore, the observed toxicity is likely due to butanone oxime and their values are comparable.
- Reason / purpose for cross-reference:
- reference to other study
- Principles of method if other than guideline:
- Read-across approach from experimental results (test method according to EPA OTS 798.4900) on an analogue substance.
- GLP compliance:
- no
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Based on the experimental results on the analogue substance where the LOAEL for maternal toxicity was determined to be 60 mg/kg bw/day (basis for effect: enlarged spleens), the read-across approach was applied and the LOAEL for maternal toxicity for 2-butanone-O,O',O''- (phenylsilylidyne)trioxime in rats was estimated to be 83.45 mg/kg bw/day. - Dose descriptor:
- NOAEL
- Effect level:
- > 834.48 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Remarks:
- (analogue substance)
- Basis for effect level:
- other: developmental toxicity
- Dose descriptor:
- LOAEL
- Effect level:
- 83.45 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Remarks:
- (analogue substance)
- Basis for effect level:
- other: maternal toxicity
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
Based on the experimental results on the analogue substance where the NOAEL for developmental toxicity was determined to be >600 mg/kg bw/day (basis for effect: no effects were observed), the read-across approach was applied and the NOAEL for developmental toxicity for 2-butanone-O,O',O''- (phenylsilylidyne)trioxime in rats was estimated to be >834.48 mg/kg bw/day. - Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- Based on the read-across approach from experimental results on analogue butanone oxime, the LOAEL for maternal toxicity for 2-butanone-O,O',O''- (phenylsilylidyne)trioxime in rats was estimated to be 83.45 mg/kg bw/day and the NOAEL for developmental toxicity >834.48 mg/kg bw/day.
- Executive summary:
A Prenatal Developmental Toxicity Test was performed on the analogue substance butanone oxime up to 600 mg/kg bw/day in Sprague-Dawley rats according to EPA OTS 798.4900. Based on the experimental results on the analogue substance where the LOAEL for maternal toxicity was determined to be 60 mg/kg bw/day (basis for effect: enlarged spleens) and the NOAEL for developmental toxicity was determined to be >600 mg/kg bw/day (basis for effect: no effects were observed), the read-across approach was applied and the LOAEL for maternal toxicity for 2-butanone-O,O',O''- (phenylsilylidyne)trioxime was estimated to be 83.45 mg/kg bw/day and the NOAEL for developmental toxicity >834.48 mg/kg bw/day.
Reference
See "Data Matrix" and "Reporting Format" attached.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 692.06 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Two studies available on an analogue substance for developmental toxicity with Klimisch scores = 2 and 3. The overall quality of the database was determined as appropriate for assessment.
Additional information
Read-across from experimental results on analogue substance butanone oxime:
Key study: A Prenatal Developmental Toxicity Test was performed on the analogue substance butanone oxime up to 600 mg/kg bw/day in Sprague-Dawley rats according to EPA OTS 798.4900. Based on the experimental results on the analogue substance where the LOAEL for maternal toxicity was determined to be 60 mg/kg bw/day (basis for effect: enlarged spleens) and the NOAEL for developmental toxicity was determined to be >600 mg/kg bw/day (basis for effect: no effects were observed), the read-across approach was applied and the LOAEL for maternal toxicity for 2-butanone-O,O',O''- (phenylsilylidyne)trioxime was estimated to be 83.45 mg/kg bw/day and the NOAEL for developmental toxicity >834.48 mg/kg bw/day.
Supporting study: A Prenatal Developmental Toxicity Test was performed on the analogue substance butanone oxime up to 600 mg/kg bw/day in New Zealand White rabbits according to EPA OTS 798.4900. Based on the experimental results on the analogue substance where the NOAEL for maternal toxicity was determined to be 24 mg/kg bw/day, the read-across approach was applied and the NOAEL for maternal toxicity for 2-butanone-O,O',O''- (phenylsilylidyne)trioxime in rabbits was estimated to be 33.38 mg/kg bw/day. In reference to the developmental toxicity, in the study performed on analogue butanone oxime only 6 rabbits produced litters due to an excessive maternal mortality and abortions at the 40 mg/kg dose level. The NOAEL for developmental toxicity was determined to be 24 mg/kg bw/day (basis for effect: a decrease in the mean number of viable fetuses and an increase in the number of early resorptions). Based on these results, the NOAEL for developmental toxicity for 2-butanone-O,O',O''- (phenylsilylidyne)trioxime in rabbits was estimated to be 33.38 mg/kg bw/day. Nevertheless, the severe maternal toxicity and limited number of litters precluded a full assessment of developmental toxicity.
Justification for selection of Effect on developmental toxicity: via oral route:
The study performed in rats was chosen due to its higher quality (key study).
Justification for classification or non-classification
Based on the available information on toxicity to reproduction and developmental toxicity, 2-butanone-O,O',O''- (phenylsilylidyne)trioxime was considered to be negative for toxicity to reproduction, and therefore the substance is not classified in accordance with CLP Regulation (EC) No 1272/2008.
Additional information
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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