Phenol, 4,4'-(1-methylethylidene)bis-, polymer with (chloromethyl)oxirane, reaction products with diethylenetriamine and 4-methyl-2-pentanone in xylene and butanol

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Phenol, 4,4'-(1-methylethylidene)bis-, polymer with (chloromethyl)oxirane, reaction products with diethylenetriamine and 4-methyl-2-pentanone in xylene and butanol

EC Number:

947-984-6

Molecular formula:

The substance is a UVCB, of which a major component can be represented by the following: C28H46ClN3O4

IUPAC Name:

Phenol, 4,4'-(1-methylethylidene)bis-, polymer with (chloromethyl)oxirane, reaction products with diethylenetriamine and 4-methyl-2-pentanone in xylene and butanol

Constituent 2

Reference substance name:

Phenol, 4,4'-(1-methylethylidene)bis-, oligomer with (chloromethyl)oxirane, reaction products with diethylenetriamine and 4-methyl-2-pentanone, n=2

IUPAC Name:

Phenol, 4,4'-(1-methylethylidene)bis-, oligomer with (chloromethyl)oxirane, reaction products with diethylenetriamine and 4-methyl-2-pentanone, n=2

Constituent 3

Reference substance name:

1,2-xylene; 1,3-xylene; 1,4-xylene; ethylbenzene

EC Number:

905-588-0

Molecular formula:

C32H40

IUPAC Name:

1,2-xylene; 1,3-xylene; 1,4-xylene; ethylbenzene

Constituent 4

Reference substance name:

Butan-1-ol

EC Number:

200-751-6

EC Name:

Butan-1-ol

Cas Number:

71-36-3

Molecular formula:

C4H10O

IUPAC Name:

butan-1-ol

Test material form:

liquid: viscous

Method

Species / strain

Species / strain / cell type:

other: TA 1535, TA 97, TA 98, TA 100 and TA 102

Additional strain / cell type characteristics:

other: histidine deficient

Metabolic activation:

with and without

Metabolic activation system:

S-9

Test concentrations with justification for top dose:

0, 2.5, 7.4, 22.2, 66.7 and 200.0 μg/mL

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: not specified

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-nitrofluorene

sodium azide

methylmethanesulfonate

other: 2-aminoanthracene and 2-aminofluorene

Details on test system and experimental conditions:

METHOD OF APPLICATION:in agar (plate incorporation)
- Cell density at seeding (if applicable): 5x10^7 to 4x10^8

DURATION
- Preincubation period: 16 hours
- Exposure duration: three days

SELECTION AGENT (mutation assays): histidine

NUMBER OF REPLICATIONS: one

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

not applicable

Positive controls validity:

not specified

Test results 2

Key result

Species / strain:

S. typhimurium TA 97

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at the two highest doses, in absence of S-9 mix

Vehicle controls validity:

not specified

Untreated negative controls validity:

not applicable

Positive controls validity:

not specified

Test results 3

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at the highest dose, in absence of S-9 mix

Vehicle controls validity:

not specified

Untreated negative controls validity:

not applicable

Positive controls validity:

not specified

Test results 4

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

not applicable

Positive controls validity:

not specified

Test results 5

Species / strain:

S. typhimurium TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at two highest doses, in absence of S-9 mix. In presence of S-9 mix at highest dose.

Vehicle controls validity:

not specified

Untreated negative controls validity:

not applicable

Positive controls validity:

not specified

Applicant's summary and conclusion

Conclusions:

It was concluded that the test substance did not show mutagenic activity in any of the Salmonella typhimurium strains, either in absence or in the presence of the S-9 mix.

Executive summary:

The test substance was examined for mutagenic activity in the Ames test using the histidine requiring Salmonella typhimurium mutants TA 1535, TA 97, TA 98, TA 100 and TA 102 as indicator strains and a liver mircosome fraction of Aroclor-induced rats for metabolic activation (S-9 mix).

It was concluded that the test substance did not show mutagenic activity in any of the S. typhimurium strains, either in absence or in the presence of the S-9 mix.