[No public or meaningful name is available]

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:

11. Oct. 2012 -07.11.2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well documented guideline study under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Initiator 94

IUPAC Name:

Initiator 94

Test material form:

other: liquid

Details on test material:

Name: Initiator 94
Batch: 004IN11
according to certificate of analysis and its addendum of 1. August 2012:
purity: 32% (main component and active species: benzpinakolsilylethers
further composition: Phosphoric acid tributylester (Tributylphosphat) 19.3 %,
1,2-Benzenedicarboxylic acid-di-2-propenylester (Diallylphthalate) 8.7%;
MEthylbenzene (toluol) 12.9%; Diphenylmethanone (Benzophenon) 12.4 %;
1,1,1,1-Tetraphenylethane-1,2-diol (Benzpinakol) 14.6%
form: liquid
colour: brown
odour: aromatic
density: 1.13 g/cm3 at 20°C
Production date of batch: 16.05.2011
Expiry date of batch: 01.02.2013

Method

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA 97a, TA 98, TA 100, TA 102, TA 1535

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

First experiment: 0, 0.05, 0.151, 0.502, 1.505, 5.016 mg/plate,
second experiment: 0, 0.313, 0.626, 1.251, 2.501, 5.001 mg/plate

Vehicle / solvent:

DMSO, (Stock solution of 50 g/L of test item in DMSO)
DMSO was chosen as vehicle, because the test item was completely soluble and this solvent doesn't have any effects on the viability of the bacteria or the number of spontaneous revertants.

Controls

Untreated negative controls:

yes

Remarks:

DMSO and water

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

yes

Remarks:

water

Positive controls:

yes

Remarks:

4-Nitro-1,2-phenylene diamine, Sodium azide, 2-Amino-anthracene, Benz-a-pyrene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in a fist test in agar (plate incorporation) and in a second test in suspension in the pre-incubation method;
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours

NUMBER OF REPLICATIONS: 4

NUMBER OF CELLS EVALUATED:

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth;

Evaluation criteria:

Number of spontaneous revertants and positive control values in the range of the histrorical data.

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA 97a, TA 98, TA 100, TA 102, TA 1535 from TRINOVA BioChem

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:

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

The test item Initiator 94 is considered as "not mutagenic under the conditions of the test".

Executive summary:

The mutagenic potential of Initiator 94 is determined with the Bacterial Reverse Mutation Test according to OECD 471/ EU-guideline B.13/14. Two valid experiments were performed, a first one using the plate incorporation method and a second one with the pre-incubation method. In both experiments five strains of Salmonella typhimurium: TA 97a, TA 98, TA 100, TA 102 and TA 1535, were used with and without metabolic activation by S9. Per strain and dose 4 plates with and 4 plates without metabolic activation were used.

In the first experiment five concentrations of the test item, ranging from 50 to 5015 µg/plate, were used and incubated for 48 hours.

In the second experiment five concentrations of the test item, ranging from 313 to 5001 µg/plate, were used and incubated for 48 hours.

In both experiments no signs of toxicity towards the bacteria and no mutagenic effects could be observed. The sterility control, the negative controls and the positive controls were within the range of historical control data.

Therefore, under the conditions of this test, the test item is considered not mutagenic.