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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Propyl (9Z,12Z)-octadeca-9,12-dienoate
Molecular formula:
C21H38O2
IUPAC Name:
Propyl (9Z,12Z)-octadeca-9,12-dienoate
Constituent 2
Chemical structure
Reference substance name:
Propyl oleate
EC Number:
203-885-3
EC Name:
Propyl oleate
Cas Number:
111-59-1
Molecular formula:
C21H40O2
IUPAC Name:
propyl oleate
Constituent 3
Chemical structure
Reference substance name:
Propyl stearate
EC Number:
222-855-0
EC Name:
Propyl stearate
Cas Number:
3634-92-2
Molecular formula:
C21H42O2
IUPAC Name:
propyl stearate
Constituent 4
Chemical structure
Reference substance name:
Heptadecanoic acid, propyl ester
Cas Number:
propyl heptadecanoate
Molecular formula:
C20H40O2
IUPAC Name:
Heptadecanoic acid, propyl ester
Constituent 5
Chemical structure
Reference substance name:
Propyl (9Z)-9-hexadecenoate
Molecular formula:
C19H36O2
IUPAC Name:
Propyl (9Z)-9-hexadecenoate
Constituent 6
Chemical structure
Reference substance name:
Propyl palmitate
EC Number:
218-803-1
EC Name:
Propyl palmitate
Cas Number:
2239-78-3
Molecular formula:
C19H38O2
IUPAC Name:
propyl palmitate
Constituent 7
Chemical structure
Reference substance name:
Pentadecanoic acid, propyl ester
Molecular formula:
C18H36O2
IUPAC Name:
Pentadecanoic acid, propyl ester
Constituent 8
Chemical structure
Reference substance name:
Propyl myristate
EC Number:
238-241-0
EC Name:
Propyl myristate
Cas Number:
14303-70-9
Molecular formula:
C17H34O2
IUPAC Name:
propyl myristate
Constituent 9
Chemical structure
Reference substance name:
Propyl laurate
EC Number:
222-961-7
EC Name:
Propyl laurate
Cas Number:
3681-78-5
Molecular formula:
C15H30O2
IUPAC Name:
propyl laurate
Test material form:
liquid
Details on test material:
Name: 9-Octadecenoic acid (9Z)-, propyl ester
Product Description: Propyl oleate
CAS No.: 111-59-1
Physical state: colourless to yellow liquid at 20 °C
Batch No.: 37584
Re-certification date of batch: 08 March 2018
Purity: > 95 % (mono constituent substance, water content 0.33 % (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
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

Method

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
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
S9 Mix
Vehicle / solvent:
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.
Controls
Untreated negative controls:
yes
Remarks:
A. dest.
Negative solvent / vehicle 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.

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:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Remarks:
Ethanol
Untreated negative controls validity:
valid
Remarks:
A. dest.
Positive controls validity:
valid
Remarks:
NaN3 (-S9); 2-AA (+S9)
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Remarks:
ethanol
Untreated negative controls validity:
valid
Remarks:
A. dest.
Positive controls validity:
valid
Remarks:
NaN3 (-S9); 2-AA (+S9)
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Remarks:
ethanol
Untreated negative controls validity:
valid
Remarks:
A. dest.
Positive controls validity:
valid
Remarks:
NaN3 (-S9); 2-AA (+S9)
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Remarks:
ethanol
Untreated negative controls validity:
valid
Remarks:
A. dest.
Positive controls validity:
valid
Remarks:
4-NOPD (-S9); 2-AA (+S9)
Key result
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Remarks:
ethanol
Untreated negative controls validity:
valid
Remarks:
A. dest.
Positive controls validity:
valid
Remarks:
MMS (-S9); 2-AA (+S9)
Remarks on result:
other: Experiment I (Plate-incorporation Test) & Experiment II (Plate-incorporation Test)

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.