1-(2-hydroxy-5-nonyl(branched)-phenyl)ethanone oxime

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

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

Test material information

Constituent 1

Reference substance name:

2-Hydroxy-5-nonyl(branched)-benzaldehyde oxime

EC Number:

605-717-8

Cas Number:

174333-80-3

Molecular formula:

C16H25NO2

IUPAC Name:

2-Hydroxy-5-nonyl(branched)-benzaldehyde oxime

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): C-SAT 090069
- Analytical purity: 89-91% active substance
- Physical state: amber coloured viscous liquid
- Lot/batch No.: C-081
- Mol. weight: 263 g/mol
- Expiration date of the lot/batch: Feb 26, 2013
- Storage condition of test material: at room temperature

Method

Target gene:

uvrB

Species / strain

Species / strain 1

Species / strain / cell type:

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

Additional strain / cell type characteristics:

not applicable

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 102

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

Experiment IIA: 0.03, 0.1, 0.3, 1, 3, 10, 33, 100 µg/plate
Pre-ExperimenUExperiment I and II: 3, 10, 33, 100, 333, 1000, 2500, 5000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: solubility properties and relatively non-toxic to the bacteria

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

for TA 1535 and TA 100 without metabolic activation

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 4-NOPD

Remarks:

for TA 1537 and TA 98 without metabolic activation

Controls 3

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

methylmethanesulfonate

Remarks:

for TA 102 without metabolic activation

Controls 4

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

not specified

Positive control substance:

other: 2-aminoanthracene

Remarks:

for all strains with metabolic activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation); preincubation

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

The Salmonella typhimurium reverse mutation assay is considered acceptable if it meets
the following criteria:
- regular background growth in the negative and solvent control
- the spontaneous reversion rates in the negative and solvent control are in the range of
our historical data
- the positive control substances should produce a significant increase in mutant colony
frequencies

A test item is considered as a mutagen if a biologically relevant increase in the number of
revertants exceeding the threshold of twice (strains TA 98, TA 100, and TA 102) or thrice
(strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is
observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded
at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically
relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is
regarded as an indication of a mutagenic potential if reproduced in an independent second
experiment. However, whenever the colony counts remain within the historical range of
negative and solvent controls such an increase is not considered biologically relevant.

Statistics:

According to the OECD guideline 471, a statistical analysis of the data is not mandatory.

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:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

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:

valid

Positive controls validity:

valid

Any other information on results incl. tables

The plates incubated with the test item showed reduced background growth with and without S9 mix in all strains used.

Toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in the test groups with and without metabolic activation.

No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with the test substance at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.

Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.

Applicant's summary and conclusion

Conclusions:

Based on the results of a study according to OECD Test Guideline 471 under GLP, the test substance is considered not to be mutagenic.

Executive summary:

The registered substance has been tested in a GLP-study according to OECD test guideline 471. The strain salmonella typhimurium TA 98, 100, 102, 1535 and 1537 were used without and with metabolic activation by S9. Appropriate, strain-specific controls were used giving valid results. The test substance was applied in suspension.

As the test substance did not give any positive result, it is considered not to be mutagenic.