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Diss Factsheets

Toxicological information

Toxicity to reproduction

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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:
2012

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

Constituent 1
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.

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)

Based on the experimental results 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 toxicity to reproduction was > 100 mg/kg bw/day since no adverse effects were observed at the highest dose, the read-across was applied and the NOAEL of EAC3 for parental toxicity and toxicity to reproduction were estimated to be 23.74 and >79.13 mg/kg bw/day respectively.

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)

Based on the experimental results on the analogue substance MIBKO in rats, where the NOAEL for F1 and developmental parameters was determined to be >100 mg/kg bw/day since no adverse effects were observed at the highest dose, the read-across was applied and the NOAEL of EAC3 was estimated to be >79.13 mg/kg bw/day.

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.