2-sec-butylphenol

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:

≥ 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD 471, 472 and Japan Guidelines for Screening Mutagenicity Of Chemicals) but study period and year of publication not clear (≥ 1996) and only summary available in English

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

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:

OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-sec-butylphenol

EC Number:

201-933-8

EC Name:

2-sec-butylphenol

Cas Number:

89-72-5

Molecular formula:

C10H14O

IUPAC Name:

2-(butan-2-yl)phenol

Details on test material:

- Name of test material (as cited in study report): o-sec-butylphenol
- Substance type: Mono-alkylphenol
- Analytical purity: 99.15%
- Impurities: p-sec-butylphenol 0.83%
- Lot/batch No.: 970922

Method

Species / strain

Species / strain 1

Species / strain / cell type:

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

Additional strain / cell type characteristics:

not specified

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

S9 Rat liver, induced with phenobarbital and 5,6-benzoflavone

Test concentrations with justification for top dose:

-S9 mix; 0, 12.5, 25, 50, 100, 200, 400 μg/plate
+S9 mix; 0, 12.5, 25, 50, 100, 200, 400 μg/plate

Vehicle / solvent:

DMSO

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide

Remarks:

TA100, TA98, WP2 uvrA, without S9

Controls 2

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

TA1535, without S9

Controls 3

Positive controls:

yes

Positive control substance:

other: aminoacridine

Remarks:

TA1537, without S9

Controls 4

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

all strains, with S9

Details on test system and experimental conditions:

METHOD OF APPLICATION: Pre-incubation
Plates/test: 3
NUMBER OF REPLICATIONS: 2

Results and discussion

Test results

Test results 1

Key result

Species / strain:

other: S. typhimurium TA100, TA1535, TA98, TA1537

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at more than 200 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 400 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

other: S. typhimurium TA1535, , TA1537

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at more than 200 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

other: Salmonella typhimurium TA100, TA98

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at more than 400 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at more than 400 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

O-sec-butylphenol was not mutagenic in Salmonella typhimurium TA100, TA1535, TA98, TA1537 and Escherichia coli WP2 uvrA with or without and exogeneous metabolic activation system.

Executive summary:

A bacterial reverse mutation test was performed to determined the genetic toxicity of o-sec-butylphenol with Salmonella typhimurium TA100, TA1535, TA98, TA1537 and Escherichia coli WP2 uvrA with and without an S9 exogeneous metabolic activation system. The test method follows OECD 471, OECD 472 and Japan Guidelines for Screening Mutagenicity Testing of Chemicals. Number of plates per test were 3. Number of replicates 2. The chemical tested did not induce gene mutations in the S. typhimurium and E. coli strains. Toxicity was observed at more than 200µg/plate (TA100, TA1535, TA98, TA1537) and at 400 µg/plate(WP2 uvrA) without an S9 mix, and at more than 200 µg/plate (TA1535, TA1537) and at 400 µg/plate (TA100, TA98, WP2 uvrA) with and S9 mix.