2-butanone-O,O',O''-(phenylsilylidyne)trioxime

Developmental toxicity / teratogenicity

Administrative data

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.

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

other: Read-across

Title:

Unnamed

Year:

2013

Materials and methods

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

Test material

Test material information

Constituent 1

Reference substance name:

Butanone oxime

EC Number:

202-496-6

EC Name:

Butanone oxime

Cas Number:

96-29-7

Molecular formula:

C4H9NO

IUPAC Name:

butan-2-one oxime

Details on test material:

- Name of test material (as cited in study report): Methyl ethyl ketoxime (MEKO)
- Molecular formula (if other than submission substance): C4H9NO
- Molecular weight (if other than submission substance): 87.12
- Smiles notation (if other than submission substance): CC(CC)=NO
- InChl (if other than submission substance): 1/C4H9NO/c1-3-4(2)5-6/h6H,3H2,1-2H3
- Structural formula attached as image file (if other than submission substance): see Fig.

Results and discussion

Results: maternal animals

Maternal developmental toxicity

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.

Effect levels (maternal animals)

1

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

2

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

Results (fetuses)

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.

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental 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 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.