Butan-2-one O,O',O'',O'''-silanetetrayltetraoxime

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in mammalian cells

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test method similar to OECD Guideline 476. No data on GLP.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)

GLP compliance:

not specified

Type of assay:

mammalian cell gene mutation assay

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): 2-Butanone oxime

Method

Species / strain

Species / strain / cell type:

mouse lymphoma L5178Y cells

Metabolic activation:

with and without

Metabolic activation system:

S9 mix (prepared from Aroclor 1254-induced male Fisher 344 rats)

Test concentrations with justification for top dose:

Without metabolic activation: 0 (control), 2.8, 3.6, 4.6, 5.5 and 6.5 µl/mL
With metabolic activation: 0 (control), 1.7, 2.8, 3.6, 4.6, 5.5 and 6.5 µl/mL

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Dimethyl sulfoxide

Controls

Controls 1

Negative solvent / vehicle controls:

yes

Controls 2

Positive controls:

yes

Positive control substance:

ethylmethanesulphonate

Remarks:

without metabolic activation

Migrated to IUCLID6: (5 µg/plate)

Controls 3

Positive controls:

yes

Positive control substance:

other: 3-methylcholanthrene (5 µg/plate)

Remarks:

with metabolic activation

Results and discussion

Test results

Species / strain:

mouse lymphoma L5178Y cells

Metabolic activation:

with and without

Genotoxicity:

positive

Remarks:

(only with cytotoxicity in the absence of S9)

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

2-butanone oxime showed evidence of mutagenic activity in the absence of S9 activation, but in the presence of cytotoxicity (it was noted that there was a dose response for both mutant frequency and relative total colony growth). No evidence of mutagenic activity was observed in the presence of S9 activation.

Any other information on results incl. tables

Results obtainend without metabolic activation:

Dose (µg/mL)	Relative total growth (% of control)	Mutant frequency (100,000 survivors)
0	100	0.50
2.8	50.0	0.75
3.6	35.5	0.95
4.6	28.5	1.3
5.5	12.5	2.0
6.5	7.5	2.65

There was a dose response for both mutant frequency and relative total colony growth.

Applicant's summary and conclusion

Conclusions:

2-butanone oxime was negative for mutagenic activity in mouse lymphoma L5178Y cells in the presence of S9 metabolic activation, but was positive in the absence of S9 metabolic activation and in the presence of cytotoxicity.

Executive summary:

A mammalian cell mutagenicity test was performed on 2 -butanone oxime in accordance with a test method similar to OECD Guideline 476. Mouse lymphoma L5178Y cells were exposed to concentrations up to 6.5 µg/plate with and without metabolic activation S9 mix prepared from Aroclor 1254-induced male Fisher 344 rats. Negative and positive controls were performed satisfactorily. 2-butanone oxime was negative for mutagenic activity in mouse lymphoma L5178Y cells in the presence of S9 metabolic activation, but was positive in the absence of S9 metabolic activation and in the presence of cytotoxicity.