Cyclohexyl methacrylate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

other: In Vitro Mammalian Chromosome Aberration Test

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohexyl methacrylate

EC Number:

202-943-5

EC Name:

Cyclohexyl methacrylate

Cas Number:

101-43-9

Molecular formula:

C10H16O2

IUPAC Name:

cyclohexyl 2-methylprop-2-enoate

Specific details on test material used for the study:

- Lot/batch No.: 12-208-222

Method

Species / strain

Species / strain / cell type:

lymphocytes: human

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

Experiment I:
without S9 mix (exposure period 24 h and 48 h)
24h: 10, 30, 100 µg/mL
48h: 100 µg/mL
with S9 mix (exposure period 4 h)
24h: 300, 600, 1680 µg/mL
48h: 1680 µg/mL

Experiment II
without S9 mix (exposure period 24 h and 48 h)
24h: 30, 100, 150 µg/mL
48h: 200 µg/mL
with S9 mix (exposure period 4 h)
24h: 500, 1000, 1680 µg/mL
48h: 1680 µg/mL

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

ethylmethanesulphonate

Remarks:

without S9 mix (0.30 mg/mL)

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

cyclophosphamide

Remarks:

with S9 mix (30 µg/mL)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium

DURATION
- Exposure duration: 4, 24, 48 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 3 hours before harvesting

SPINDLE INHIBITOR (cytogenetic assays): Colcemid
STAIN (for cytogenetic assays): Giemsa

NUMBER OF REPLICATIONS: 2

NUMBER OF CELLS EVALUATED: 200 per dose

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index

Statistics:

Statistical significance at the five per cent level (p < 0.05) was evaluated by means of the chi-square test. Evaluation was performed only for cells carrying aberrations exclusive gaps.

Results and discussion

Test results

Key result

Species / strain:

lymphocytes: human

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Any other information on results incl. tables

Experiment I (exposure period 24 h)

fixation interval 24 h after start of the treatment

Test groups	S9 mix	Analyses of chromosomes
		Incl. Gaps %	Excl. gaps %
Negative control	-	2.00	1.00
1% Solvent control DMSO	-	1.50	0.50
0.33 mg/ml Positive contol	-	16.00	13.0
10 µg/ml Test article	-	1.00	1.0
30 µg/ml Test article	-	0.00	0.00
100 µg/ml Test article	-	1.00	0.50

 

Experiment I (exposure period 48 h)

fixation interval 48 h after start of the treatment

Test groups	S9 mix	Analyses of chromosomes
		Incl. Gaps %	Excl. gaps %
1% Solvent control DMSO	-	1.50	1.00
100 µg/ml Test article	-	1.50	0.50

 

Experiment II (exposure period 24 h)

fixation interval 24 h after start of the treatment

Test groups	S9 mix	Analyses of chromosomes
		Incl. Gaps %	Excl. gaps %
Negative control	-	3.50	1.50
1.0% Solvent control DMSO	-	2.00	1.50
0.33 mg/ml Positive contol	-	14.50	10.00
30 µg/ml Test article	-	2.00	1.00
100 µg/ml Test article	-	1.50	0.50
150 µg/ml Test article	-	1.00	0.50

 

Experiment II (exposure period 48 h)

fixation interval 48 h after start of the treatment

Test groups	S9 mix	Analyses of chromosomes
		Incl. Gaps %	Excl. gaps %
1.0% Solvent control DMSO	-	0.00	0.00
150 µg/ml Test article	-	3.00	2.00

 

 

 

 

 

 

Experiment I (exposure period 4 h)

fixation interval 24 h after start of the treatment

Test groups	S9 mix	Analyses of chromosomes
		Incl. Gaps %	Excl. gaps %
Negative control	+	0.50	0.00
1.0% Solvent control DMSO	+	0.50	0.50
30.0 µg/ml Positive contol CPA	+	17.00	14.00
300 µg/ml Test article	+	0.50	0.00
600 µg/ml Test article	+	2.00	1.00
1680 µg/ml Test article	+	1.00	0.50

 

Experiment I (exposure period 4 h)

fixation interval 48 h after start of the treatment

Test groups	S9 mix	Analyses of chromosomes
		Incl. Gaps %	Excl. gaps %
1.0% Solvent control DMSO	+	1.00	0.50
1680 µg/ml Test article	+	0.00	0.00

 

Experiment II (exposure period 4 h)

fixation interval 24 h after start of the treatment

Test groups	S9 mix	Analyses of chromosomes
		Incl. Gaps %	Excl. gaps %
Negative control	+	2.00	1.00
1.0% Solvent control DMSO	+	1.50	0.00
30.0 µg/ml Positive contol CPA	+	10.50	10.00
500 µg/ml Test article	+	1.00	0.00
1000 µg/ml Test article	+	1.00	0.50
1680 µg/ml Test article	+	0.00	0.00

 

Experiment II (exposure period 4 h)

fixation interval 48 h after start of the treatment

Test groups	S9 mix	Analyses of chromosomes
		Incl. Gaps %	Excl. gaps %
1.0% Solvent control DMSO	+	0.50	0.50
1680 µg/ml Test article	+	2.50	1.50