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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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: meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
an additional S. typhimurium strain (TA 1538) was tested, but no E. coli strain was examined.
Principles of method if other than guideline:
The test substance Myristylchloroformiate was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several strains of Salmonella typhimurium in a reverse mutation assay (Ames test).
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetradecyl chloroformate
EC Number:
260-330-8
EC Name:
Tetradecyl chloroformate
Cas Number:
56677-60-2
Molecular formula:
C15H29ClO2
IUPAC Name:
tetradecyl carbonochloridate
Details on test material:
- Name of test material (as cited in study report): Myristylchlorformiat
- Physical state: liquid
- Analytical purity: ca. 99 %

Method

Target gene:
his gene
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Metabolic activation:
with and without
Metabolic activation system:
S-9 mix
Test concentrations with justification for top dose:
20, 100, 500, 2500, and 5000 ug/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: [acetone]
- Justification for choice of solvent/vehicle: none given
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene (in DMSO)
Remarks:
with S-9 mix for strains TA 100, TA 98, TA 1538, TA 1537 and TA 1535
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: N-Methyl-N'-nitro-N-nitrosoguanidine (in DMSO)
Remarks:
without S-9 mix for strains TA 1537, TA 98, TA 100, and TA 1535.
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 4-nitro-o-phenylenediamine (in DMSO)
Remarks:
without S-9 mix for strains TA 1538 and TA 98
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
without S-9 mix for strains TA 1537
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)


DURATION
- Exposure duration: 48 hours at 37°C


DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
Evaluation criteria:
The test chemical ist considered positive in this assay if the following criteria are met:
- A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S-9 mix or after adding a metabolizing system.
Statistics:
no data

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:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Under the experimental conditions chosen, it is concluded that Myristylchlorformiat is not a mutagenic agent in the Salmonella typhimurium reverse
mutation assay (Ames test).
Executive summary:

According to the results of the study, the test substance did not lead to an increase in the number of revertant colonies either without S-9 mix or after adding a metabolizing system in two experiments carried out independently of each other. The maximum increase observed at any concentration and in any strain tested did never exceed factor 1.5.