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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Well-conducted GLP study done according to accepted protocol. No COA for the batch tested was provided; however, sponsor has provided a letter confirming that the test article is representative of a substance of which the exact composition is available. The recommended strains TA 102 or E. coli WP2 were not tested. Only one positive control substance was tested in the presence of S9 mix. Deviations in accordance with guideline at time of study conduction.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
the recommended strains TA 102 or E. coli WP2 were not tested; only one positive control substance was tested in the presence of S9 mix; deviations in accordance with guideline at time of study conduction
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
(Z)-docos-13-enamide
EC Number:
204-009-2
EC Name:
(Z)-docos-13-enamide
Cas Number:
112-84-5
IUPAC Name:
docos-13-enamide
Details on test material:
- Analytical purity: 97%

Method

Target gene:
his
Species / strain
Species / strain / cell type:
other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
Rat liver S-9, Aroclor-induced
Test concentrations with justification for top dose:
Range-finding study: 5, 50, 500, 5000 µg / plate; definitive study 5000, 1500, 500, 150, 50 µg/plate.
Vehicle / solvent:
tetrahydrofuran (109-99-9)
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
tetrahydrofuran
True negative controls:
no
Positive controls:
yes
Remarks:
-S9: ENNG (3 µg/plate TA 100; 5 µg/plate TA 1535), 2-NF (1 µg/plate: TA 98; 2 µg/plate TA 1538), 9-AA (80 µg/plate TA 1537); +S9: 2-AA (0.5 µg/plate TA 1538 and TA 98; 1 µg/plate: TA 100; 2 µg/plate: TA 1535 and TA 1537)
Positive control substance:
9-aminoacridine
2-nitrofluorene
N-ethyl-N-nitro-N-nitrosoguanidine
other: 2-aminoanthracene
Remarks:
ENNG = N-ethyl-N-nitro-N-nitrosoguanidine; 2-NF: 2-nitrofluorene; 9-AA: 9-aminoacridine; 2-AA: 2-aminoanthracene

Results and discussion

Test results
Species / strain:
other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and 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
Untreated negative controls validity:
not applicable
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:
When tested at dose levels up to 5000 µg/plate in tetrahydrofuran, erucamide was not mutagenic in this bacterial test system.
Executive summary:

In this in vitro assessment of the mutagenic potential of erucamide, histidine dependent auxotrophic mutants of Salmonella typhimurium (strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100) were exposed to the test material diluted in tetrahydrofuran, which was also used as a negative control.

Two independent mutation tests were performed, in the presence and absence of liver preparations from Aroclor 1254-induced rats.

In the preliminary dose range finding study with dose levels of up to 5000 µg/plate no toxicity was observed. A top dose level of 5000 µg/plate was chosen for the subsequent mutation study. Other dose levels used in the mutation assays were: 1500, 500, 150 and 50 µg/plate.

The concurrent positive control compounds demonstrated the sensitivity of the assay and the metabolising activity of the liver preparations.

No evidence of mutagenic activity was seen at any dose level of erucamide in either mutation test.

It is concluded that, when tested at dose levels up to 5000 µg/plate in tetrahydrofuran, erucamide was not mutagenic in this bacterial test system.