(7-methoxynaphthalen-1-yl)acetonitrile

Genetic toxicity: in vitro

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

Study period:

2008

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

and EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

The aim of the sudy was to compare two batches.
Batch No.: M06015/001 (chemical purity: 100.8%); Batch No.: 20098/A8DRT022B (chemical purity of 101.0%).

Method

Target gene:

histidine

Species / strain

Species / strain / cell type:

S. typhimurium TA 1537

Metabolic activation:

with and without

Metabolic activation system:

Arochlor induced rat liver S9 , final concentration: 0.8 % (v/v) S9

Test concentrations with justification for top dose:

The tested concentrations of Menaphtacyan used were selected from a previous study. (GERVAIS V. and Delongeas J-L (2006) Menaphtacyan Genotoxicity study: Detection of Reverse Mutation in histidine-requiring TA1537 Salmonella typhimurium (Ames test). Biologie Servier Internal report No. 5731.

Vehicle / solvent:

Dimethyl sulphoxide (DMSO)

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

Migrated to IUCLID6: and 2-anthramine

Details on test system and experimental conditions:

-direct plating preincubation
-independent experiments-triplicates/concentrations

Evaluation criteria:

-genotoxicity (bacterial lawn and number of revertants)
-genotoxictity (number of revertants)

Statistics:

Statistical analysis using automated decision tree.
For positive control, Student t test versus vehicle control on square root data.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: generally from 250 μg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

Genotoxic effects:
Slight, isolated but statistically significant increase in the numbers of revertant colonies was noted for the batch M06015/001 at 125 μg/plate in the direct plating method without methabolic activation. As this increase was not concentration related, did not reach 3.0-fold the solvent control and remained near the highest value of our historical data (18 versus 17), the M06015/001 was considered as devoid of mutagenic potential.
No increase was noted in with the batch 20098A8DRT022B. In conclusion no genotoxic effects was observed with both batches.

Cytotoxic effects:
For both batches, a reduction in size of colonies was noted from 250 μg/plate with and without metabolic activation, reaching a reduction in the numbers of colonies at 1000 μg/plate. Clearing of the bacterial lawn was noted at 1000 μg/plate without metabolic activation and from 500 μg/plate with metabolic activation.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative in TA1537

In conclusion no genotoxic effects was observed with both batches.