[No public or meaningful name is available]

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to an appropriate OECD test guideline, with acceptable restrictions. The restrictions were that only four strains of bacteria were used. Read across to the registered substance is considered scientifically justified.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

1983

Deviations:

yes

Remarks:

only four strains of bacteria used

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C6-12

EC Number:

271-642-9

EC Name:

Alcohols, C6-12

Cas Number:

68603-15-6

IUPAC Name:

octan-1-ol

Method

Target gene:

Histidine operon

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 S9

Test concentrations with justification for top dose:

50, 158, 500, 1590 and 5000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: none given in report

Controls

Controls 1

Untreated negative controls:

other: sterility checks of S9 and test substance, and bacteria plated alone

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

TA 1535 and TA 100 without metabolic activation

Controls 2

Untreated negative controls:

other: sterility checks of S9 and test substance

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

TA 1535 with and without metabolic activation

Controls 3

Untreated negative controls:

other: sterility checks of S9 and test substance

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

TA 1537 without metabolic activation

Controls 4

Untreated negative controls:

other: sterility checks of S9 and test substance

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

TA 98 without metabolic activation

Controls 5

Untreated negative controls:

other: sterility checks of S9 and test substance

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

benzo(a)pyrene

Remarks:

TA 1537, TA 100 and TA 98 with metabolic activation

Details on test system and experimental conditions:

ACTIVATION: S9 mix contained 10% S9, NADP and glucose-6-phosphate as cofactors.

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: none
- Exposure duration: 48 hours at 37°C

SELECTION AGENT (mutation assays): histidine deficient agar

NUMBER OF REPLICATIONS: triplicate plates, experiment repeated

DETERMINATION OF CYTOTOXICITY

Evaluation criteria:

None described in report

Statistics:

None described in report

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 nor precipitates, but tested up to recommended limit concentrations

Remarks:

no cytotoxicity observed at any concentration.

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- none reported

RANGE-FINDING/SCREENING STUDIES: No toxicity was observed in the preliminary toxicity test, and no increase in revertant colonies occurred.

COMPARISON WITH HISTORICAL CONTROL DATA: no information

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1 Experiment 1 Plate incorporation: number of revertants per plate (mean of three plates)

Concentration (µg/plate)	TA 98		TA 100		TA 1535		TA 1537
	+MA	-MA	+MA	-MA	+MA	-MA	+MA	-MA
None; sterility check	0	-	0	-	0	-	0	-
5000 (sterility check)	-	0	-	0	-	0	-	0
5000	28	22	110	111	13	9	4	3
1580	31	33	121	118	14	12	7	6
500	30	27	119	123	12	14	10	4
158	27	30	132	128	15	14	8	7
50	26	28	141	113	15	14	7	10
DMSO	34	31	126	116	18	16	7	8
Positive control 1	484	26	710	113	339	25	176	10
Positive control 2	-	149	-	948	-	799	-	1018
Culture only *	-	101	-	92	-	121	-	101

*10E-6 dilution of bacterial culture only; plated on nutrient: agar total colony counts 

 

Table 2 Experiment 2 Plate incorporation: number of revertants per plate (mean of three plates)

Concentration (µg/plate)	TA 98		TA 100		TA 1535		TA 1537
	+MA	-MA	+MA	-MA	+MA	-MA	+MA	-MA
None; sterility check	0	-	0	-	0	-	0	-
5000 (sterility check)	-	0	-	0	-	0	-	0
5000	28	23	101	98	14	11	7	5
1580	28	26	110	100	13	15	6	8
500	27	26	99	94	16	19	9	7
158	26	27	102	100	16	13	7	6
50	25	27	120	97	19	15	6	6
DMSO	32	28	104	99	19	17	9	8
Positive control 1	541	24	775	105	211	22	150	4
Positive control 2	-	138	-	875	-	698	-	1243
Culture only *	-	100	-	102	-	111	-	102

*10E-6 dilution of bacterial culture only; plated on nutrient: agar total colony counts

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with and without metabolic activation

The C6-12 alcohol Linevol 79 did not increase the reverse mutation rate in histidine dependent bacterial strains of Salmonella typhimurium in the presence or absence of metabolic activation at dose levels up to and including 5000 µg/plate. All positive controls gave an appropriate response. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.