Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
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.

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 data (according to OECD Guideline 402 and GLP) on analogue substance acetone oxime.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Acetone oxime
EC Number:
204-820-1
EC Name:
Acetone oxime
Cas Number:
127-06-0
Molecular formula:
C3H7NO
IUPAC Name:
acetone oxime
Details on test material:
- Name of test material (as cited in study report): Acetone oxime
- Molecular formula (if other than submission substance): C3H7NO
- Molecular weight (if other than submission substance): 73.09378
- Smiles notation (if other than submission substance): CC(=NO)C
- InChl (if other than submission substance): 1/C3H7NO/c1-3(2)4-5/h5H,1-2H3
- Structural formula attached as image file (if other than submission substance): see Fig.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 493.77 mg/kg bw
Based on:
test mat.
Remarks on result:
other: (read-across approach from an analogue)

Any other information on results incl. tables

See "Data Matrix" and "Reporting Format" attached.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on experimental data on the analogue acetone oxime (test method according to OECD 402 and GLP), the read-across approach was applied and the acute dermal LD50 of the test item EAC3 was determined to be greater than 2493.77 mg/kg body weight in male and female rats.
Executive summary:

An acute dermal toxicity study was performed with the analogue substance acetone oxime in CRL:(WI) rats, in compliance with OECD 402. A limit test was carried out at 2000 mg/kg body weight (bw) in both sexes (5 rats/sex). The test item was applied as supplied as a single dermal 24-hour exposure followed by a 14-day observation period. No effects were observed. The acute dermal LD50 of the analogue acetone oxime was found to be greater than 2000 mg/kg bw in male and female rats. Based on these results, the read-across approach was applied and the the acute dermal LD50 of EAC3 was determined to be greater than 2493.77 mg/kg bw in male and female rats.