Dodecene, hydroformylation products, high-boiling

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

(only 4 strains tested)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Dodecene, hydroformylation products, high-boiling

EC Number:

271-239-8

EC Name:

Dodecene, hydroformylation products, high-boiling

Cas Number:

68526-91-0

Molecular formula:

Unspecified

IUPAC Name:

Reaction products of dodecene, hydroformylation products, high boiling

Details on test material:

- Name of test material (as cited in study report): Oxooel 13
- Physical state: yellow, liquid
- Composition of test material, percentage of components: > 80% mixture of aliphatic esters and alcohols in the C range of 26 - 39; 10-20% mixture of diols and monoalcohols in the C13 range
- Lot/batch No.: from storage tank 82
- Storage condition of test material: room temperature
- Other: test substance number: 91/234

Method

Target gene:

his-operon

Species / strain

Species / strain / cell type:

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

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254 induced rat liver (Sprague-Dawley) S9 mix

Test concentrations with justification for top dose:

20-5000 µg/plate

Vehicle / solvent:

- solvent used: DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

(DMSO)

Positive controls:

yes

Positive control substance:

other: see: "Details on test system and conditions."

Details on test system and experimental conditions:

POSITIVE CONTROLS:
with S9 mix; for all strains: 2-aminoanthracene (10 µg/plate);
without S9 mix; for the strains TA100 and TA1535: N-methyl-N'-nitro-N-nitroso-guanidine (5 µg/plate);
without S9 mix; for the strain TA98: 4-nitro-o-phenylendiamine (10 µg/plate)
without S9 mix; for the strain TA98: 9-aminoacridine chloride monohydrate (100 µg/plate)

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

DURATION
- Preincubation period: 20 min
- Exposure duration: 48 hrs (37°C)

REPLICANTS: 3

SELECTION AGENT (mutation assays): Vogel-Bonner-agar

Evaluation criteria:

a substance to be characterized as positive has to fulfill 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, other: TA1535, TA1537, TA100, TA98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

(depending on the strain and test conditions at doses >/= 2500 µg/plate)

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

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 (20 - 5000 µg/plate)
Strain	Metabolic activation system	mean his^+ revertant colonies (negative control)	maximum revertant factor (conc. (µg/plate))	dose dependency	Assessment	maximum revertant factor (positive control)
TA 98	no	25	1.1 (20)	no	negative	55.6
	yes	38	1.1 (100)	no	negative	31.8
TA 100	no	100	1 (100)	no	negative	21.9
	yes	99	1.2 (20)	no	negative	15.3
TA 1537	no	13	1 (20, 100)	no	negative	82
	yes	16	1 (100)	no	negative	8.9
TA1535	no	17	1 (500)	no	negative	118.7
	yes	19	0.9 (20,100,500)	no	negative	11.5
Preincubation test (20 - 5000 µg/plate)
Strain	Metabolic activation system	mean his^+ revertant colonies (control)	maximum revertant factor (conc. (µg/plate))	dose dependency	Assessment	maximum revertant factor (positive control)
TA 98	no	25	0.9 (100)	no	negative	27.1
	yes	37	1 (5000)	no	negative	16.3
TA 100	no	105	1 (20, 100)	no	negative	5.5
	yes	108	1 (20)	no	negative	5.9
TA 1537	no	10	1.2 (100)	no	negative	37.5
	yes	13	1 (20)	no	negative	6.2
TA 1535	no	16	0.9 (100)	no	negative	60.1
	yes	15	0.9 (20)	no	negative	4.5

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

According to the results of the present study, the test substance Oxooel 13 is not mutagenic in the Salmonella typhimurium reverse mutation assay under the experimental conditions chosen here.

Executive summary:

The study is conducted according to the OECD Guideline 471 and is reliable without any restriction (deviation: only 4 strains tested).

Oxooel 13 was tested in the standard plate test as well as in the preincubation assay with and without metabolic activation (MA) in S. typhimurium TA98, TA100, TA1535 and TA1537 at dose levels of 20 -5000 µg/plate. No increase in the number of revertants was detected in any strain with and without MA. Vehicle controls and positive controls were valid. Cytotoxicity was found depending on the strain and test conditions in concentrations >/= 2500 µg/plate.

Conclusion:   

According to the results of the present study, the test substance Oxooel 13 is not mutagenic in the Salmonella typhimurium reverse mutation assay under the experimental conditions chosen here.