Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, Propyl oleate did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used. Therefore, Propyl oleate is considered to be non-mutagenic in this bacterial reverse mutation assay.

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay
Test material information:
Composition 1
Specific details on test material used for the study:
Name: 9-Octadecenoic acid (9Z)-, propyl ester
Product Description: Propyl oleate
CAS No.: 111-59-1
Physical state: pale yellow to yellow liquid at 20 °C
Batch No.: 37584
Re-certification date of batch: 08 March 2018
Purity: > 99 % (fatty acid propyl esters, max water content 0.3 % (w/w))
Free Fatty Acid, % Oleic: 0.1
Color, Gardner: 3
Iodine Value, cg I2/g 75
Cloud Point, degrees C 0
Saponification Number, mg KOH/g 177
Moisture, % 0,07
Stability: stable under test conditions
Storage condition of test material: Room temperature, protected from light
Target gene:
The Salmonella typhimurium histidine (his) reversion system measures his- → his+ reversions. The S. typhimurium strains are constructed to differentiate between base pair (TA 100, TA 1535, TA 102) and frameshift (TA 98, TA 1537) mutations.
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Additional strain characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
S9 Mix
Vehicle:
The test item was dissolved in ethanol and diluted prior to treatment. The solvent was compatible with the survival of the bacteria and the S9 activity.
Negative controls:
yes
Remarks:
A. dest.
Solvent controls:
yes
Remarks:
Ethanol
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
sodium azide
methylmethanesulfonate
other: 1. 4-NOPD; 4-nitro-o-phenylene-diamine; 2. 2-AA; 2-aminoanthracene
Evaluation criteria:
Evaluation of Mutagenicity

The Mutation Factor is calculated by dividing the mean value of the revertant counts by the mean values of the solvent control (the exact and not the rounded values are used for calculation).

A test item is considered as mutagenic if:

- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs

in at least one tester strain with or without metabolic activation.

A biologically relevant increase is described as follows:

- if in tester strains TA 98, TA 100 and TA 102 the number of reversions is at least twice as high
- if in tester strains TA 1535 and TA 1537 the number of reversions is at least three times higher

than the reversion rate of the solvent control.
Statistics:
According to OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary. A test item producing neither a dose related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups is considered to be non-mutagenic in this system.
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
no, but tested up to limit concentrations
Vehicle controls valid:
yes
Remarks:
Ethanol
Negative controls valid:
yes
Remarks:
A. dest.
Positive controls valid:
yes
Remarks:
NaN3 (-S9); 2-AA (+S9)
Remarks on result:
other: Experiment I (Plate-incorporation Test) & Experiment II (Plate-incorporation Test)
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
no, but tested up to limit concentrations
Vehicle controls valid:
yes
Remarks:
ethanol
Negative controls valid:
yes
Remarks:
A. dest.
Positive controls valid:
yes
Remarks:
NaN3 (-S9); 2-AA (+S9)
Remarks on result:
other: Experiment I (Plate-incorporation Test) & Experiment II (Plate-incorporation Test)
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
no, but tested up to limit concentrations
Vehicle controls valid:
yes
Remarks:
ethanol
Negative controls valid:
yes
Remarks:
A. dest.
Positive controls valid:
yes
Remarks:
NaN3 (-S9); 2-AA (+S9)
Remarks on result:
other: Experiment I (Plate-incorporation Test) & Experiment II (Plate-incorporation Test)
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
no, but tested up to limit concentrations
Vehicle controls valid:
yes
Remarks:
ethanol
Negative controls valid:
yes
Remarks:
A. dest.
Positive controls valid:
yes
Remarks:
4-NOPD (-S9); 2-AA (+S9)
Remarks on result:
other: Experiment I (Plate-incorporation Test) & Experiment II (Plate-incorporation Test)
Key result
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
no, but tested up to limit concentrations
Vehicle controls valid:
yes
Remarks:
ethanol
Negative controls valid:
yes
Remarks:
A. dest.
Positive controls valid:
yes
Remarks:
MMS (-S9); 2-AA (+S9)
Remarks on result:
other: Experiment I (Plate-incorporation Test) & Experiment II (Plate-incorporation Test)

Discussion

The test item Propyl oleate was investigated for its potential to induce gene mutations according to the plate incorporation test (experiment I and II) using Salmonella typhimurium strains TA 98,TA 100, TA 1535, TA 1537 and TA 102.

In two independent experiments several concentrations of the test item were used. Each assay was conducted with and without metabolic activation. The concentrations, including the controls, were tested in triplicate. The following concentrations of the test item were prepared and used in the experiments:

Experiment I: 0.0316, 0.100, 0.316, 1.0, 2.5 and 5.0 µL/plate

Experiment II: 0.0158, 0.050, 0.158, 0.50, 1.58 and 5.0µL/plate

No precipitation of the test item was observed in any tester strain used in experiment I and II (with and without metabolic activation).

No toxic effects of the test item were noted in any of the five tester strains used up to the highest dose group evaluated with and without metabolic activation in experiment I and II. No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with Propyl oleate at any concentration level, neither in the presence nor absence of metabolic activation in experiment I and II. All criteria of validity were met.

In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, Propyl oleate did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used. Therefore, Propyl oleate is considered to be non-mutagenic in this bacterial reverse mutation assay.

Conclusions:
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, Propyl oleate did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used. Therefore, Propyl oleate is considered to be non-mutagenic in this bacterial reverse mutation assay.
Executive summary:

The test item Propyl oleate was investigated for its potential to induce gene mutations according to the plate incorporation test (experiment I and II) using Salmonella typhimurium strains TA 98,TA 100, TA 1535, TA 1537 and TA 102.

In two independent experiments several concentrations of the test item were used. Each assay was conducted with and without metabolic activation. No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with Propyl oleate at any concentration level, neither in the presence nor absence of metabolic activation in experiment I and II. All criteria of validity were met. In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, Propyl oleate did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used. Therefore, Propyl oleate is considered to be non-mutagenic in this bacterial reverse mutation assay.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification