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Toxicological information

Genetic toxicity: in vitro

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to
Guideline:
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
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
Controlsopen allclose all
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
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
TA1535, without S9
Positive controls:
yes
Positive control substance:
other: aminoacridine
Remarks:
TA1537, without S9
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 resultsopen allclose all
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
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
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
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
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.