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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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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

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
2007
Report date:
2007
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
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

Constituent 1
Chemical structure
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 / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
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 resultsopen allclose all
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
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).