Di(µ-2,2´,2´´-nitrilotris(ethanol)-diperchlorato)dinatrium

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-study according to OECD guideline 471 (Bacterial Reverse Mutation Test)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

The pure active substance was used.
Purity: 98%
Batch number: AH0612 W001-01
Production date: 20.12.2006
Expiry date: 30.06.2008
Storage: Closed vessel at room temperature (acc. to recommended conditions)

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 97

Species / strain 3

Species / strain / cell type:

S. typhimurium TA 98

Species / strain 4

Species / strain / cell type:

S. typhimurium TA 100

Species / strain 5

Species / strain / cell type:

S. typhimurium TA 102

Metabolic activation:

with and without

Metabolic activation system:

S9 (Trinova Biochem, Gießen, Germany, batch no. 2061, 2113, 2078)

Test concentrations with justification for top dose:

50, 150, 500, 1502, 5005 µg/plate (1st experiment)
1250, 2500, 5000 µg/plate (2nd experiment)

Vehicle / solvent:

deionised water

Controls

Controls 1

Untreated negative controls:

yes

Remarks:

water

Negative solvent / vehicle controls:

yes

Remarks:

water

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

without S9, 80µg for TA 97a, TA 98, TA 102

Controls 2

Untreated negative controls:

yes

Remarks:

water

Negative solvent / vehicle controls:

yes

Remarks:

water

Positive controls:

yes

Positive control substance:

other: 4-nitro-1,2-phenylene diamine

Remarks:

without S9, 6µg for TA 100, TA 1535

Controls 3

Untreated negative controls:

yes

Remarks:

water

Negative solvent / vehicle controls:

yes

Remarks:

water

Positive control substance:

benzo(a)pyrene

Remarks:

with S9, 40µg for TA 98

Controls 4

Untreated negative controls:

yes

Remarks:

water

Negative solvent / vehicle controls:

yes

Remarks:

water

Positive control substance:

other: 2-aminoanthracene

Remarks:

with S9, 40µg for TA 98

Details on test system and experimental conditions:

All strains were obtained from Prof. Ames in the year 2001 and 2002 and stored as stock cultures at -80°C.
One day before the start of the experiments, one vial per strain was thawed and put into a culture vessel containing nutrient broth.

Evaluation criteria:

The test substance is considered to have mutagenic potential, if at least a reproducible two-fold increase of revertant colonies per plate in at least one strain can be observed. A concentration-realted increaseover the range tested can also be considered as a sign of mutagenic activity.

Statistics:

Mean values and standard deviations as well as increase factors of colony counts were calculated.

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

ambiguous

Remarks:

non concentration dependend borderline positive response in one concentration withou S9

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Remarks:

No signs of toxicity was present. The background lawm was visible and the number of revertant colonies was not reduced.

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 97

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Remarks:

No signs of toxicity was present. The background lawm was visible and the number of revertant colonies was not reduced.

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Remarks:

No signs of toxicity was present. The background lawm was visible and the number of revertant colonies was not reduced.

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Remarks:

No signs of toxicity was present. The background lawm was visible and the number of revertant colonies was not reduced.

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 5

Species / strain:

S. typhimurium TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Remarks:

No signs of toxicity was present. The background lawm was visible and the number of revertant colonies was not reduced.

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Only in TA1535 without metabolic a borderline increase in a non-concentration dependent way was observed.

As this could not be confirmed in the second experiment, this increase was considered negligible.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The test substance is considered non mutagenic under the conditions of the test.