3-cyano-3,5,5-trimethylcyclohexanone

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study with acceptable restrictions (missing strain for cross-linking/oxidizing agents)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

missing strain for cross-linking/oxidizing agents

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3-cyano-3,5,5-trimethylcyclohexanone

EC Number:

411-490-4

EC Name:

3-cyano-3,5,5-trimethylcyclohexanone

Cas Number:

7027-11-4

Molecular formula:

C10 H15 N O

IUPAC Name:

3-cyano-3,5,5-trimethylcyclohexanone

Details on test material:

- Analytical purity: 98.2%
- Batch No.: KW 7877 514-4

Method

Target gene:

his+

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

Aroclor induced rat liver S-9 mix

Test concentrations with justification for top dose:

0, 20, 100, 500, 2500, 5000 µg/plate

Vehicle / solvent:

None

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: + S-9 mix: 2-aminoanthracene; -S9-mix: N-methyl-N'-nitro-N-nitrosoguanidine for TA 100 and TA 1535; 4-nitro-o-phenylendiamine for TA 98; 9-aminoacridine chloride monohydrate for TA 1537

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation) and preincubation

DURATION
- Preincubation period: 20 min
- Expression time (cells in growth medium): 48 h

Evaluation criteria:

In general, a substance to be characterized as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

		STANDARD PLATE TEST		PREINCUBATION TEST
strain	S9 mix	Revertants in Veh. Control	Max Revertants (dose µg/plate)	Revertants in Veh. Control	Max Revertants (dose µg/plate)
T98	-	32	40 (100)	36	39 (500)
	+	48	46 (20)	34	37 (100)
T100	-	124	139 (100)	96	90 (20)
	+	137	139 (20)	97	111 (100)
T1535	-	23	35 (100)	20	21 (20)
	+	23	23 (20)	19	18 (100)
T1537	-	18	23 (20)	13	14 (20)
	+	23	22 (100)	10	14 (500)

Table: Results of the ames test