(Z)-octadec-9-enol

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 from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1989-04-12 to 1989-04-21

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was conducted according to an appropriate OECD test guideline, with acceptable restrictions. The restrictions were that the range of strains does not comply with the current guideline. Read across to the registered substance is considered scientifically justified.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

range of strains

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C16-18 and C18-unsatd.

EC Number:

268-106-1

EC Name:

Alcohols, C16-18 and C18-unsatd.

Cas Number:

68002-94-8

IUPAC Name:

68002-94-8

Method

Species / strain

Species / strain / cell type:

S. typhimurium, other: strains TA98, TA100, TA1535, TA1537, and TA1538

Metabolic activation:

with and without

Metabolic activation system:

Aroclor induced rat liver S9

Test concentrations with justification for top dose:

8, 40, 200, 1,000, 5,000 µg/plate

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

all strains with metabolic activation

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

TA 1537 without metabolic activation

Controls 3

Untreated negative controls:

no

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 4

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylene diamine

Remarks:

TA 98 and TA 1538 without metabolic activation

Details on test system and experimental conditions:

- Number of replicates: Two independent tests each conducted in  triplicate.
- Application: Plate incorporation assay, vehicle aqueous suspension with  Tween 80.
- Incubation time: 48 hours at 37C.

Evaluation criteria:

A two fold increase in reverse mutation  rate is considered positive in strain TA 100 and a 3 fold increase  positive for the other strains.

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA98, TA100, TA1535, TA1537, and TA1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: 5000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

PRECIPITATION CONCENTRATION: Not reported CYTOTOXIC CONCENTRATION:  - With and without metabolic activation: 5000 µg/plate evidenced by  reduced background lawn and/or reduced revertant rates.

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 revertants per plate (mean of 3 plates)

Concentration µg/plate	TA 1535	TA 100	TA 1537	TA 1538	TA 98	TA 1535	TA 100	TA 1537	TA 1538	TA 98
	without metabolic activation					with metabolic activation
0*	8.1	123.4	8.3	13	19.6	11.8	158	12.1	20.1	23.1
8	6.6	110.6	9.3	8.3	17	13.6	151.3	10.3	22.6	22
40	9	99.3	6	8.3	15.3	12.3	128.6	11.3	19	22
200	6	102.6	5.3	10	26.3	8.6	120.3	10.6	17	33.6
1000	7	93.6	7.6	14	20	11.3	102.3	7.3	18.3	33
5000	8	91.3	4.3	10.3	15	12	99.6	4.6	17.6	26.3
Positive control 1	357.3	503	170	1923.6	841.3	112	298	155.6	1347.3	675.6
Positive control 2**	7.6	133.6	6.6	16	19.6	104	1313.6	97.3	1085.3	714.6

* Vehicle control with Tween 80/water

** Positive control 2 is 2-aminoanthracene

 

Table 2 Experiment 2 revertants per plate (mean of 3 plates)

Concentration µg/plate	TA 1535	TA 100	TA 1537	TA 1538	TA 98	TA 1535	TA 100	TA 1537	TA 1538	TA 98
	without metabolic activation					with metabolic activation
0*	7.5	109.6	7.3	11.5	16.8	11.3	104.6	8.3	14.3	25
8	9	104	12.3	10.3	23.3	8.6	98	12.3	14.3	-
40	9.3	114.3	7.6	9	24.3	9.3	96.6	9.6	14.6	23.5
200	8.3	107.3	10	13.3	24.6	11	103.3	5	15.3	33
1000	7.6	97.6	7.6	11.3	15.6	8.3	118.3	5.3	16.3	25.6
5000	5	90.6	8.3	10.3	21.3	12.6	96.3	6.3	12.6	27.3
Positive control 1	309	325	306.6	1263.3	907.6	146.6	226	206.6	1142.6	597.3
Positive control 2**	9	98.6	4.3	13	22.3	45.6	483.3	27.6	5334.3	339

 

* Vehicle control with Tween 80/water

** Positive control 2 is 2-aminoanthracene

Applicant's summary and conclusion

Conclusions:

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

HD-Ocenol 90/95 has been tested according to OECD 471 and under GLP. The test substance 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 PRECIPITATION CONCENTRATION: Not reported CYTOTOXIC CONCENTRATION:  - With and without metabolic activation: 5000 µg/plate evidenced by  reduced background lawn and/or reduced revertant rates.
g/plate. Evidence of cytotoxicity was observed at 5000 ug/plate (highest dose level tested). It is concluded that the test substance is negative for mutagenicity to bacteria under the conditons of the test.