1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)

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:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: no guideline study but followed scientifically accepted standards and meet many of the requirements of OECD Test Guideline 471.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

not applicable

GLP compliance:

no

Remarks:

not required at time of testing

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Octopirox

IUPAC Name:

Octopirox

Constituent 2

Reference substance name:

piroctone olamine

IUPAC Name:

piroctone olamine

Constituent 3

Reference substance name:

1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)

EC Number:

272-574-2

EC Name:

1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)

Cas Number:

68890-66-4

Molecular formula:

C14H23NO2.C2H7NO

IUPAC Name:

1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)

Constituent 4

Reference substance name:

1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone, 2-aminoethanol salt

IUPAC Name:

1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone, 2-aminoethanol salt

Method

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

S9-mix from Aroclor 1254 pretreated rats

Test concentrations with justification for top dose:

2, 20, 100, 250, 500 microgram per plate

Vehicle / solvent:

DMSO
ethanol

Details on test system and experimental conditions:

METHOD OF APPLICATION:

DURATION
- Expression time (cells in growth medium): 48 hours
- Selection time (if incubation with a selection agent): 48 hours

NUMBER OF REPLICATIONS: 1

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

Numbers of reverted bacterial colonies

Statistics:

Comparison to negative / positive controls

Results and discussion

Test results

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:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no confounding factor
- Effects of osmolality: no confounding factor
- Evaporation from medium: no confounding factor
- Water solubility: no confounding factor
- Precipitation: no confounding factor
- Other confounding effects: none

ADDITIONAL INFORMATION ON CYTOTOXICITY:
No bacterial growth above 100 microgram per plate

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

not mutagenic in the Ames-test with or without metabolic activation

Executive summary:

Piroctone Olamine was investigated for mutagenicity with the Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537. The tests were performed in the presence and absence of a metabolizing system derived from rat liver homogenate (S9 -mix). A dose-range of 0.2 to 500 microgram per plate was used. Cytotoxicity as measured by general bacterial growth was observed at the highest doses tested. There were no conspicous behaviour in dose-response with regard to revertant colonies. Increases in numbers of revertants were not observed. Based on the results obtained, piroctone olamine is not mutagenic in these bacterial test systems either with or witout exogenous metabolic activation.