Phenol, 4-isocyanato-, 1,1',1''-phosphorothioate, reaction p roducts with 3-(trimethoxysilyl)-N-(3-(trimethoxysilyl)propy l)-1-propanamine

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:

2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD GLP Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 2000/32/EG, B.13, B.14 (Ames-Test); OECD 471

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Reference

Name:

Unnamed

Type:

Constituent

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Metabolic activation system:

rat liver S9, PB/betaNF induced

Test concentrations with justification for top dose:

Concentration range in the main test (with metabolic activation): 50, 150, 500, 1500 and 5000 µg/plate
Concentration range in the main test (without metabolic activation): 50, 150, 500, 1500 and 5000 µg/plate

Vehicle / solvent:

dimethyl formamide

Controls

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: see details field

Details on test system and experimental conditions:

Vehicle and positive controls were used in parallel with the test material. A solvent treatment
group was used as the vehicle control and the positive control materials in the absence of S9 were
as follows:
N-ethyl-N'-nitro-N-nitrosoguanidine (ENNG): 3 ug/plate for TA100 and 5 ug/plate for TA1535
9-Aminoacridine (9AA):80 ug/plate for TA1537
Mitomycin C (MMC):0.5 ug/plate for TAI02
4-Nitroquinoline-l-oxide (4NQO):0.2 ug/plate for T A98
In addition, 2-Aminoanthracene (2AA), Benzo(a)pyrene (BP) and 1,8-Dihydroxyanthraquinone
(DAN), which are non-mutagenic in the absence of metabolising enzymes, were used in the S9
series of plates at the following concentrations:
2AA:1 ug/plate for T Al 00
2AA:2 ug/plate for TA1535 and TA1537
BP:5 ug/plate for T A98
DAN:10 ug/plate for TAlO2

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

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 examined

Positive controls validity:

valid

Additional information on results:

The test material was non-toxic to the strain of Salmonella used (TAl 00). The test material
formulation and the S9-mix used in this experiment were both shown to be sterile.
Results for the negative controls (spontaneous mutation rates) are presented in Table 1 and were
considered to be acceptable. These data are for concurrent untreated control plates performed on
the same day as the Mutation Test.
The test material caused no visible reduction in the growth of the bacterial background lawn at
any dose level. The test material was, therefore, tested up to the maximum recommended dose
level of 5000 Ilg/plate. A particulate test material precipitate and film was observed at
5000 Ilg/plate. These observations did not prevent the scoring of revertant colonies.
No biologically significant increases in the frequency of revertant colonies were recorded for any
of the bacterial strains, with any dose of the test material, either with or without metabolic
activation. A small statistically significant increase in revertant colony frequency was observed
for bacterial strain TAlOO, (presence ofS9), at 1500 ~g/plate only in Experiment 1. This increase
was considered to be of no biological relevance because there was no evidence of a dose-response
relationship or reproducibility. Furthermore, the revertant counts at 1500 ~glplate were within the
in-house historical control range for the tester strain and the fold increase was only 1.16 times the
concurrent vehicle control.
All of the positive control chemicals used in the test induced marked increases in the frequency of
revertant colonies thus confirming the activity of the S9-mix and the sensitivity of the bacterial
strains.

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 metabolic activation
negative without metabolic activation

The test material was considered to be non-mutagenic under the conditions of this test.