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Registration Dossier
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EC number: 611-631-1 | CAS number: 58190-57-1
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- 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. 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 results (test method according to OECD Guideline 408, GLP study) on the analogue substance MIBKO
- GLP compliance:
- 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 of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Based on the experimental results obtained in the analogue substance MIBKO, where the NOAEL for 90 days oral exposure in male and female rats was determined to be 15 mg/kg bw/day based on the effects on red blood cells, resulting in associated changes in the spleen), the read-across approach was applied and the NOAEL (90 days, oral) for EAC3 in rats was estimated to be 11.87 mg/kg bw/day in rats.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 11.87 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: (Read-across approach from an analogue substance) (Basis for effect: effects on red blood cells, resulting in associated changes in the spleen)
Target system / organ toxicity
- Critical 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 analogue substance MIBKO (OECD Guideline 408, GLP study), the NOAEL of EAC3 for 90 days oral exposure in rats was determined to be 11.87 mg/kg bw/day.
- Executive summary:
A 90 days oral repeated dose toxicity test was performed on the analogue substance MIBKO according to OECD Guideline 407 and GLP. The NOAEL was determined to be 15 mg/kg bw/day in rats based on the effects on red blood cells, resulting in associated changes in the spleen were observed at 50 mg/kg bw/day. Based on these results, the read-across was applied and the NOAEL of EAC3 for 90 days oral exposure in rats was estimated to be 11.87 mg/kg bw/day under the test conditions (effects at an estimated concentration of 39.57 mg/kg bw/day).
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