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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
not stated
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
limited reporting

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
OECD Guidelines recommend using TA 102 or E. coli to detect cross-linking/oxidising agents.
Principles of method if other than guideline:
An in-house protocol similar to OECD No. 471
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Octan-1-ol
EC Number:
203-917-6
EC Name:
Octan-1-ol
Cas Number:
111-87-5
Molecular formula:
C8H18O
IUPAC Name:
octan-1-ol

Method

Target gene:
Histidine
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537, and TA 1538
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced rat liver S9
Test concentrations with justification for top dose:
4, 20, 100, 500, and 2500 µg/plate
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
Water/Tween 80
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene (5 µg/plate), sodium azide (1 µg/plate), 4-nitro-o-phenylenediamine (40 µg/plate)
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

NUMBER OF REPLICATIONS: Four per dose level.
Evaluation criteria:
No data

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
500 and 2500 μg/plate with and without metabolic activation
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
2500 μg/plate
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at 2500 μg/plate
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
500 μg/plate with metabolic activation and 2500 μg/plate with and without metabolic activation
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
500 and 2500 μg/plate with and without metabolic activation
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: not reported

ADDITIONAL INFORMATION ON CYTOTOXICITY:
- With metabolic activation: Total inhibition of bacterial growth at 2500 ug/plate for all strains tested; also at 500 ug/plate for strains TA1537, TA1538 and TA98.
- Without metabolic activation: Total inhibition of bacterial growth at 2500 ug/plate for all strains tested; also at 500 ug/plate for strains TA1538 and TA98.
Remarks on result:
other: No mutagenic potential

Applicant's summary and conclusion

Conclusions:
In a reliable study, using a method similar to OECD test guideline 471, C8 alcohol Lorol C8 at concentrations up to 2500 µg/plate did not increase the reverse mutation rate in five histidine dependent bacterial strains of Salmonella typhimurium, in the presence or absence of a mammalian liver metabolic activation system (S9). Cytotoxicity was observed at the highest concentration tested.
Executive summary:

In a bacterial mutagenicity study, S. typhimurium cells TA 98, TA 100, TA 1535, TA 1537, and TA 1538 were exposed to 4, 20, 100, 500, and 2500 µg/plate of test material, without or with metabolic activation.

There was no increase in the reverse mutation rate in the five histidine dependent bacterial strains. Cytotoxicity was observed at the highest concentration. The study concludes that the test material is negative for mutagenicity to bacterial cells under the conditions of the study. The study was conducted according to a protocol similar to OECD TG 471, and in compliance with GLP.