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Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
2008-09-02 TO 2008-09-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Version / remarks:
1998
Deviations:
no
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Constituent 1
Reference substance name:
Butan-2-one O,O',O''-(vinylsilylidyne)trioxime
EC Number:
218-747-8
EC Name:
Butan-2-one O,O',O''-(vinylsilylidyne)trioxime
Cas Number:
2224-33-1
IUPAC Name:
butan-2-one O,O',O''-(vinylsilanetriyl)oxime

Test animals

Species:
mouse
Strain:
ICR
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan, Frederick, MD, USA,
- Age at study initiation: 6 weeks
- Weight at study initiation: Males: 27.4 – 31.0 g; Females: 24.6 – 29.0 g
- Assigned to test groups randomly: yes
- Fasting period before study: no
- Housing: up to five per rodent Micro-Barrier cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
- Vehicle(s)/solvent(s) used: corn oil
- Justification for choice of solvent/vehicle: good solubility/workability of the test article in the vehicle and compatability with the test system and route of administration.
- Concentration of test material in vehicle: stock concentration of 200 mg/ml wasdiluted to give doses used, at a constant volume of 10 ml/kg
Frequency of treatment:
Single treatment
Post exposure period:
24 or 48 hours
Doses / concentrations
Remarks:
Doses / Concentrations:
1000, 1300, 1600 and 1800 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
5/sex/group
Control animals:
yes, concurrent vehicle
Positive control(s):
- cyclophosphamide
- Justification for choice of positive control(s): none given in report - standard control
- Route of administration: IP
- Doses / concentrations: (50 mg/kg) bw

Examinations

Tissues and cell types examined:
Bone marrow
Details of tissue and slide preparation:
CRITERIA FOR DOSE SELECTION: BAsed on a ppilot toxicity study followed by a toxicity study

TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): 24 and 48 hours post-dose

DETAILS OF SLIDE PREPARATION: cells were washed, resuspended, fixed on glass slides with methanol, stained with May-Gruenwald-Giemsa stain

METHOD OF ANALYSIS: light microsocope - area selected at x400, analysis performed at x 1000
2000 PCEs scored for presence of micronuclei; incidence of NCEs, ( normochromatic erythrocytes), MNCEs (micronucleated normochromatic erythrocytes) and total erythrocytes, and the incidence of MNCEs per 2000 PCEs was enumerated, but not presented in report.


OTHER:
Evaluation criteria:
The test article would have been considered to induce a positive response if a dose responsive increase in the incidence of micronucleated polychromatic erythrocytes is observed and one or more doses are statistically elevated relative to the vehicle control (p≤ 0.05, Kastenbaum-Bowman Tables) at any sampling time.
The test article was judged negative if no statistically significant increase in micronucleated polychromatic erythrocytes above the concurrent vehicle control values and no evidence of dose response were observed at any sampling time.
Statistics:
Kastenbaum-Bowman Tables

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
yes
Remarks:
reduction in PCE/total erythrocytes in males at highest dose, 48 h exposure
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative