Reaction mass of methyl N-octadecylterephthalamate and 37437-26-6

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

In order to assess the potential of the test substance to induce mutagenicity an AMES test according to OECD 471 guideline was performed in Salomonella typhimurium and Escherichia coli with and without metabolic system.

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2016-01-31 to 2016-02-17

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented GLP compliant study report

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254 induced rat liver S9-mix

Test concentrations with justification for top dose:

For dierct plate assay with the tester strains, TA1535, TA1537 and TA98 in the absence and presence of S9-mix: 5.4, 17, 52, 164 and 512 μg/plate.
For Pre incubation experiment: tested at the dose levels of 5.4, 17, 52, 164 and 512 μg/plate in the tester strains TA1535, TA1537, TA98, TA100 and WP2uvrA (in the absence and presence of S9-mix)

Vehicle / solvent:

ethanol

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

2-nitrofluorene

sodium azide

methylmethanesulfonate

other: ICR-191 (Sigma); 2-aminoanthracene (2AA)

Evaluation criteria:

Data evaluation and statistical procedures:
In addition to the criteria stated below, any increase in the total number of revertants should be evaluated for its biological relevance including a comparison of the results with the historical control data range.

A test item is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 or WP2uvrA is not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537 or TA98 is not greater than three (3) times the concurrent control.
b) The negative response should be reproducible in at least one follow up experiment.

A test item is considered positive (mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 or WP2uvrA is greater than two (2) times the concurrent control, or the total number of revertants in tester strains TA1535, TA1537 or TA98 is greater than three (3) times the concurrent control.
b) In case a repeat experiment is performed when a positive response is observed in one of the tester strains, the positive response should be reproducible in at least one follow up experiment.

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

In the direct plate test as well as in the pre-incubation test, no increase in the number of revertants was observed upon treatment with HOSTAGEL HT 300 under all conditions tested.

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Remarks:

No reduction of the bacterial background lawn and no biologically significant decrease in the number of revertants were observed. For strain TA1537 fluctuation of revertants below lab historical controls with no dose relation was observed at lowest dose.

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Conclusions:

Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

Based on the results obtained with the OECD 471 AMES test, the test item is regarded as not mutagenic.

Executive summary:

HOSTAGEL HT 300 was tested in the Salmonella typhimurium reverse mutation assay with four histidine-requiring strains of Salmonella typhimurium (TA1535, TA1537, TA100 and TA98) and in the Escherichia coli reverse mutation assay with a tryptophan-requiring strain of Escherichia coli (WP2uvrA). The test was performed in two independent experiments, at first a direct plate assay was performed and secondly a pre-incubation assay both in the absence and presence of S9-mix (rat liver S9-mix induced Aroclor 1254).

The test item was tested in the first mutation assay at a concentration range of 5.4 to 512 μg/plate in the absence and presence of S9-mix in the tester strains TA1535, TA1537 and TA98. HOSTAGEL HT 300 precipitated on the plates at the top dose of 512 μg/plate. The bacterial background lawn was not reduced at any of the concentrations tested. No biologically relevant devrease in the number of revertants was observed.

In the second mutation experiment, HOSTAGEL HT 300 was tested up to concentrations of 512 μg/plate in the tester strains TA1535, TA1537, TA98, TA100 and WP2uvrA in the pre-incubation assay. HOSTAGEL HT 300 precipitated on the plates at dose levels of 164 and 512 μg/plate. The bacterial background lawn was not reduced at any of the concentrations tested and no biologically relevant decrease in the number of revertants was observed.

HOSTAGEL HT 300 did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in an independently repeated experiment.

Based on the results of this study it is concluded that HOSTAGEL HT 300 is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

In order to assess the potential of the test substance to induce mutagenicity an AMES test according to OECD 471 guideline was performed in Salomonella typhimurium and Escherichia coli with and without metabolic system (i.e. strains S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2).

All bacterial strains showed negative responses over the entire dose range, i.e. no significant dose-related increase in the number of revertants in two independently repeated experiments. The negative control values were within the laboratory historical control data ranges, except the response for TA98 in the absence of S9-mix, second experiment. However since the mean number of revertant colonies showed a characteristic number of revertant colonies (9 revertant colonies) when compared against relevant historical control data (10 relevant colonies), the validity of the test was considered to be not affected. Sufficient positive controls were used to inticate the validity of the test system.

Based on the results of this study it is concluded that the test substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.

.

Justification for selection of genetic toxicity endpoint
Well documented GLP compliant study report

Justification for classification or non-classification

Based on the available data no classification is warranted according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).