Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 Oct 2007 - 25 Jan 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Version / remarks:
adopted 2001
Deviations:
no
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): O,O',O''-(ethenylsilylidyne)trioxime 2-butanone
- Substance type: Ketoxime
- Physical state: Liquid
- Stability under test conditions: Stable in sealed containers
- Storage condition of test material: Stored in sealed containers, may be sensitive to moisture

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Labs, Shaver Road, Portage, MI, USA
- Age at study initiation: 8 wk
- Weight at study initiation: 206-284 g
- Fasting period before study: overnight
- Housing: 1/suspended wire mesh cage
- Diet: LabDiet 5002, Certified Rodent Diet (PMI nutrition International), ad libitum
- Water: drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.95-23.63
- Humidity (%): 43-58
- Air changes (per hr): 12.5
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2007-10-8 To: 2007-10-29

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: < 10 ml/kg bw

- Rationale for the selection of the starting dose: lower than LD50 for closely related material
Doses:
550, 2000 mg/kg bw
No. of animals per sex per dose:
550 mg/kg bw: 1 male; 2000 mg/kg bw: 3 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality/viability: twice daily (once daily on weekends and holidays); weight: prior to dosing and weekly thereafter
- Necropsy of survivors performed: yes
- Clinical observations: 20-40 min after dosing, 3-4 h after dosing, and daily thereafter
Statistics:
none applied for determination of LD50

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No deaths.
Mortality:
none
Clinical signs:
2000 mg/kg bw: Two of three rats showed transient adverse effects including absence of or decreased activity, increased lacrimation, partially closed eye lids bilaterally, irregular respiration, red soiling of the muzzle or urogenital staining. These effects were no longer evident on day 3.
Body weight:
No treatment-related effects.
Gross pathology:
One animal at 2000 mg/kg bw had a small focus on the left lateral liver lobe.
Other findings:
None.

Any other information on results incl. tables

One male rat was given a single dose of 550 mg/kg bw of the test substance by oral gavage. The animal showed no adverse effects within 3 days of dosing and appeared healthy. A second fastened male was dosed with 2000 mg/kg bw and also showed no adverse effects within 3 days of dosing and appeared healthy. A third male rat was dosed with 2000 mg/kg bw and showed adverse effects which were fully reversible within 3 days. Another rat was dosed with 2000 mg/kg bw and also showed adverse effects, which were reversible within 3 days.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
A reliable acute oral toxicity study conducted in compliance with a standard guideline and GLP (reliability score 1), identified an LD50 in excess of 2000 mg/kg bw in male rats.
Executive summary:

An acute oral toxicity test was performed according to OECD 425 and GLP on butan-2-one O,O',O''-(vinylsilanetriyl)oxime. No mortality was observed and the LD50 was determined to be >2000 mg/kg bw in rats.Two of three rats showed transient adverse clinical signs which were no longer evident on day 3.