2,4,7,9-tetramethyldec-5-yne-4,7-diol

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

Study period:

1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2,4,7,9-tetramethyldec-5-yne-4,7-diol

EC Number:

204-809-1

EC Name:

2,4,7,9-tetramethyldec-5-yne-4,7-diol

Cas Number:

126-86-3

Molecular formula:

C14 H26 O2

IUPAC Name:

2,4,7,9-tetramethyldec-5-yne-4,7-diol

Details on test material:

Batch# 23058
Purity: 98,7 %

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Metabolic activation system:

S-9 mix

Test concentrations with justification for top dose:

0, 10, 50, 100, 500, 1000, and 5000 ug/plate

Vehicle / solvent:

DMSO

Controls

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

Migrated to IUCLID6: Sodium azide, 2-Nitrofluorene, 2-Anthramine

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 1000 µg/plate and above

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 1000 µg/plate and above

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 1000 µg/plate and above

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 1000 µg/plate and above

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 5

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 1000 µg/plate and above

Vehicle controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

The 5000 ug/plate dose formulation appeared to be immiscible in the tubes and on the plates. Precipitate was also observed in the tubes and on the plates at a dose level of 5000 ug. However after the 48-hour incubation period the precipitate was no longer seen on the plates. Cytotoxicity, indicated by thinning of the background bacterial lawn and the formation of pinpoint nonrevertant colonies, was observed for all strains generally at dose levels of 1000 and 5000 ug/plate. 
No 2,4,7,9-tetramethyl-5-decyne-4,7-diol treatments of the test strains resulted in an increase in revertant numbers that was considered indicative of any mutagenic activity.

Applicant's summary and conclusion

Conclusions:

No 2,4,7,9-tetramethyl-5-decyne-4,7-diol treatments of the test strains resulted in an increase in revertant numbers that was considered indicative of any mutagenic activity.

Executive summary:

2,4,7,9-Tetramethyl-5-decyne-4,7-diol was not mutagenic under the test conditions used in this bacterial assay. 2,4,7,9-tetramethyl-5-decyne-4,7-diol diluted in DMSO was examined for mutagenic activity in the Salmonella-Escherichia coli/microsome plate incorporation assay. The assay was performed using the standard plate incorporation procedure with S. typhimurium strains TA1535, TA1537, TA98, and TA100 and E. coli strain WP2 (uvrA) over a dose range of 10 to 5000 ug/plate in both the presence and absence of an Aroclor 1254-induced rat-liver metabolic activation system. The initial experiment used 5 percent (v/v) metabolic activation and the repeat experiment used 10 percent (v/v) metabolic activation. The 5000 ug/plate dose formulation appeared to be immiscible in the tubes and on the plates. Precipitate was also observed in the tubes and on the plates at a dose level of 5000 ug. However after the 48-hour incubation period the precipitate was no longer seen on the plates. Cytotoxicity, indicated by thinning of the background bacterial lawn and the formation of pinpoint nonrevertant colonies, was observed for all strains generally at dose levels of 1000 and 5000 ug/plate. No 2,4,7,9-tetramethyl-5-decyne-4,7-diol treatments of the test strains resulted in an increase in revertant numbers that was considered indicative of any mutagenic activity.