3,5,5-trimethylhexan-1-ol

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: Comparable to guideline study (SIDS documents; Iuclid reference [29]; Reliability assigned: 1)

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

2007

Report date:

2007

Reference 2

Reference Type:

review article or handbook

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3,5,5-trimethylhexan-1-ol

EC Number:

222-376-7

EC Name:

3,5,5-trimethylhexan-1-ol

Cas Number:

3452-97-9

Molecular formula:

C9H20O

IUPAC Name:

3,5,5-trimethylhexan-1-ol

Details on test material:

- Source: KYOWA HAKKO KOGYO CO., LTD.
- Analytical purity: 92.7 %
- Lot/batch No.: 707173

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

Rat liver 9000g supernatant, induded with phenobarbital and 5,6-benzoflavone

Test concentrations with justification for top dose:

TA1535, WP2uvrA, TA98: 15.6-500 µg/plate
TA100, TA1537: 6.25-200 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: commonl y used solvent in the Ames test

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: several; cf. Remarks

Remarks:

2 -(2-Furyl)-3-(5-nitro-2-furyl) acrylamide; Sodium azide; 9-Aminoacridine; 2-Aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)


DURATION; no data

Number of paltes: 3

NUMBER OF REPLICATIONS: 2



DETERMINATION OF CYTOTOXICITY : no data

Evaluation criteria:

at least doubling of the control revertant rate, reproducibility, dose depency

Statistics:

not specified

Results and discussion

Test results

Test results 1

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:

cytotoxicity

Vehicle controls validity:

not applicable

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

not applicable

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

isononanol did not induce mutations in the S. typhimurium and E. coli strains. Toxicity was observed at 150 μg/plate (TA100, TA1537), 250 μg/plate (TA1535, TA98, WP2) without an S9 mix, and at 150 μg/plate (TA100, TA1537), 250 μg/plate (TA1535, TA98), 500 μg/plate (WP2) with an S9 mix.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'. Remarks: up to 500 µg/plate (-/+ metabol activation)

Any other information on results incl. tables

This chemical did not induce mutations in the S. typhimurium and E. coli strains:

Genetic effects:

Salmonella typhimurium TA100, TA1535, TA98, TA1537

Without metabolic activation: negative

With metabolic activation: negative

Escherichia coli WP2 uvrA

Without metabolic activation: negative

With metabolic activation: negative

 

Cytotoxicity: Toxicity was observed as follows:

Without S9 mix:

at 150 µ/plate (TA100, TA1537),

at 250 µg/plate (TA1535, TA98, WP2)

With S9 mix:

at 150 µg/plate (TA100, TA1537)

at 250 µg/plate (TA1535, TA98)

at 500 µg/plate (WP2)

 

 

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative in all test strains, with or without metabolic activation

3, 5, 5-trimethylhexan1-ol was not mutagenic in bacterial test systems using S. thyphimurium (strains TA98, TA100, TA1535, TA1537) and E. coli strain Wp2 uvrA, with or without metabolic activation.

Executive summary:

The genetic toxicity of 3, 5, 5-trimethylhexan1-ol was tested according to OECD TG 471 and 472 under GLP in bacterial test systems using S. thyphimurium (strains TA98, TA100, TA1535, TA1537) and E. coli strain Wp2 uvrA, in the absence or presence of induced rat liver 9000 supernatant for metabolic activation (S9 mix). The test substance did not increase the number of revertants, with or without metabolic activation, when it was tested up to cytotoxic concentrations. Positive substances performed as expected. Therefore, the test material was not mutagenic (MHLW, 1997).