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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
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- 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. Moreover, the analogue methyl isobutyl ketoxime, which shares the same functional groups with acetone oxime, also has comparable values for the relevant molecular properties and they are toxicologically equivalent.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- other: Read-across
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
- Principles of method if other than guideline:
- Read-across approach from experimental data (test method equivalent to OECD Guideline 415, no data on GLP) on an analogue substance.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 4-methylpentan-2-one oxime
- EC Number:
- 203-298-2
- EC Name:
- 4-methylpentan-2-one oxime
- Cas Number:
- 105-44-2
- IUPAC Name:
- 4-methylpentan-2-one oxime
- Details on test material:
- - Name of test material (as cited in study report): Methyl isobutil ketoxime (MIBKO)
- Molecular formula (if other than submission substance): C6H13NO
- Molecular weight (if other than submission substance): 115.1735
- Smiles notation (if other than submission substance): CC(C)CC(\C)=N\O
- InChl (if other than submission substance): 1/C6H13NO/c1-5(2)4-6(3)7-8/h5,8H,4H2,1-3H3/b7-6+
- Structural formula attached as image file (if other than submission substance): see Fig.
Constituent 1
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- (at an estimated dose of 79.13 mg/kg bw/day)
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- (at an estimated dose of 79.13 mg/kg bw/day)
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Details on results (P0)
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- (parental toxicity)
- Effect level:
- 23.74 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks:
- (analogue substance)
- Sex:
- male/female
- Basis for effect level:
- other: (Read-across approach from an analogue) (Based on histological effects on the spleen)
- Dose descriptor:
- NOAEL
- Remarks:
- (reproductive toxicity)
- Effect level:
- > 79.13 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks:
- (analogue substance)
- Sex:
- male/female
- Basis for effect level:
- other: (Read-across approach from an analogue) (Based on no effects at the highest dose tested)
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
Details on results (F1)
Effect levels (F1)
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- (F1 toxicity)
- Generation:
- F1
- Effect level:
- > 79.13 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks:
- (analogue substance)
- Sex:
- male/female
- Basis for effect level:
- other: (Read-across approach from an analogue) (Based on no effects at the highest dose tested)
- Dose descriptor:
- NOAEL
- Remarks:
- (developmental and sexual maturation)
- Generation:
- F1
- Effect level:
- > 79.13 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks:
- (analogue substance)
- Sex:
- male/female
- Basis for effect level:
- other: (Based on no effects at the highest dose tested)
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
See "Data Matrix" and "Reporting Format" attached.
Applicant's summary and conclusion
- Conclusions:
- Based on the read-across approach from experimental data on the analogue substance MIBKO (a one-generation reproduction study in, OECD 415, no data on GLP), the NOAEL for parental toxicity was estimated to be 23.74 mg/kg bw/day (based on histological effects on the spleen) and the NOAEL for the F1 generation and reproductive toxicity was estimated to be >79.13 mg/kg bw/day (based on no effects on reproduction or developmental parameters or in the F1 pups).
- Executive summary:
Based on the experimental data from the one-generation reproduction study on the analogue substance MIBKO in rats, where the NOAEL for parental toxicity was determined to be 30 mg/kg bw/day based on histological effects on the spleen and where the NOAEL for F1 and toxicity to reproduction was > 100 mg/kg bw/day based on no effects on reproductive or developmental parameters or in the F1 pups at the highest dose, the read-across was applied and the NOAEL of EAC3 for parental toxicity, and F1 and toxicity to reproduction were estimated to be 23.74 and >79.13 mg/kg bw/day respectively.
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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