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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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

Currently viewing:

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: according to guideline and GLP, no preincubation method used.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
3,7-dimethyloctan-1-ol
EC Number:
203-374-5
EC Name:
3,7-dimethyloctan-1-ol
Cas Number:
106-21-8
Molecular formula:
C10H22O
IUPAC Name:
3,7-dimethyloctan-1-ol
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): TETRAHYDROGERANIOL
- Physical state: liquid, pale to yellowish
- Lot/batch No.: 50546023
- Analytical purity: 95.1 %
- Storage condition of test material: cool, dry, dark

Method

Target gene:
histidine
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not applicable
Species / strain / cell type:
S. typhimurium TA 102
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced rat liver S9 homogenate
Test concentrations with justification for top dose:
with S9 mix: 1.5, 5, 15, 50, 150, 500, 1500 µg/plate
without S9 mix: 1.5, 5, 15, 50, 150, 500 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Remarks:
for TA98
Positive control substance:
2-nitrofluorene
Remarks:
without S9 homogenate

Migrated to IUCLID6: 2.5 µg/plate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Remarks:
fot TA100, TA 1535
Positive control substance:
sodium azide
Remarks:
without S9 homogenate

Migrated to IUCLID6: 0.7 µg/plate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Remarks:
for TA1537
Positive control substance:
9-aminoacridine
Remarks:
without S9 homogenate

Migrated to IUCLID6: 50 µg/plate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Remarks:
for TA102
Positive control substance:
mitomycin C
Remarks:
wihout S9 homogenate

Migrated to IUCLID6: 0.15 µg/plate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Remarks:
for TA98, TA100, TA102, TA1535
Positive control substance:
other: 2-aminoanthracene, 0.8 µg/plate
Remarks:
with S9 homogenate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Remarks:
for TA1537
Positive control substance:
other: 2-aminoanthracene, 1.7 µg/plate
Remarks:
with S9 homogenate
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 - 72 h


DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of revertant colonies and/or a diminution of the background lawn

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:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: not observed

ADDITIONAL INFORMATION ON CYTOTOXICITY:
Cytotoxic concentrations:
Without S9:
150ug/plate for TA1537;
500 µg/plate for TA98, TA100, TA1535; TA102

With S9:
500 µg/plate for TA98, TA100, TA1535, TA102
1500 µg/plate - for TA1537
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion