Propylidynetrimethanol, propoxylated, reaction products with ammonia

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

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

Test material information

Constituent 1

Test material form:

liquid

Details on test material:

Name of test material: Trimethylolpropanepoly(oxypropylene)triamine
EC no.: 500-105-6
CAS no.: 39423-51-3
Physical state: clear colourless liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: J-98

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: no data
- Stability under test conditions: no apparent change in the physical state of the test or control articles during the assay

OTHER SPECIFICS:
- Name of test material (as cited in study report): 4236-44-30

Method

Species / strain

Species / strain 1

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

not applicable

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Details on mammalian cell type (if applicable):

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S-9 fraction of rat liver homogenate obtained from Arcolor 1254-treated Sprague Dawley rats

Test concentrations with justification for top dose:

12, 40, 120, 400 and 1200 µg/plate

Vehicle / solvent:

-solvent(s) used: distilled water

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

with and without metabolic activation

True negative controls:

no

Positive controls:

yes

Remarks:

without metabolic activation

Positive control substance:

sodium azide

Remarks:

TA1535 and TA100=10 µg/ml

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

with and without metabolic activation

True negative controls:

no

Positive controls:

yes

Remarks:

without metabolic activation

Positive control substance:

2-nitrofluorene

Remarks:

TA1538 and TA98=50 µg/ml

Controls 3

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

with and without metabolic activation

True negative controls:

no

Positive controls:

yes

Remarks:

without metabolic activation

Positive control substance:

9-aminoacridine

Remarks:

TA1537=1500 µg/ml

Controls 4

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

with and without metabolic activation

True negative controls:

no

Positive controls:

yes

Remarks:

with metabolic activation

Positive control substance:

other: 2-anthramine

Remarks:

in all strains=50 µg/ml

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation);


DURATION
- Preincubation period: 48h
- Exposure duration: 48-72h



SELECTION AGENT (mutation assays): histidine and biotin



NUMBER OF REPLICATIONS:
positive and negative controls: in triplicate
treated groups: in duplicate
tester strains: treated with five levels of the test compound




DETERMINATION OF CYTOTOXICITY
- Method: growth inhibition is tetsted at the following concentrations: 10,000, 3333, 1000, 333 and 100 µg/plate with strains TA1538 and TA100 ( in duplicate).

Evaluation criteria:

revertant colonies are counted (Artek Counter Model 880)
- positive result is defined as a reproducible, dose-related increase in the number of histidine-independent colonies
- negative result is defined as the absence of a reproducible increase in the number of histidine-independent colonies

Results and discussion

Test results

Test results 1

Key result

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

RANGE-FINDING/SCREENING STUDIES: dose levels for the Preliminary Toxicity Screen were 10,000, 3333, 1000, 333 and 100 µg/plate.
Tester Strains TA1538 and TA100 showed complete inhibition at 10,000 ug/plate, excessive inhibition at 3333 µg/plate and moderate inhibition a t 1000 µg/plate.


COMPARISON WITH HISTORICAL CONTROL DATA: all positive and negative controls were within acceptable range of mean historical data

Remarks on result:

other: all strains/cell types tested

Applicant's summary and conclusion

Conclusions:

The results for the test article 4236-44-30, Order# 5-98, were negative in strains TA1535, TA1537, TA1538, TA98 and TA100 of Salmonella typhimurium both with and without metabolic activation preparation at 1200, 400, 120, 40 and 12 µg/plate.