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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from J check

Data source

Reference
Reference Type:
other: J check
Title:
Gene toxicity in vitro study for Polyoxyethylene p-nonylphenyl ether
Author:
National Institute of Technology and Evaluation
Year:
2017
Bibliographic source:
Japan Chemical Collaborative Knowledge Database, 2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
Gene mutation toxicity study was performed to evaluate the mutagenic nature of Polyoxyethylene p-nonylphenyl ether
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material: Polyoxyethylene p-nonylphenyl ether;Poly(oxy-1,2-ethanediyl),alpha-(nonylphenyl)-omega-hydroxy-
- Molecular formula: (C2H4O)nC15H24O
- Molecular weight: 308.459 g/mol
- Substance type: Organic
Specific details on test material used for the study:
- Name of test material: Polyoxyethylene p-nonylphenyl ether
- EC name: Nonylphenol, ethoxylated
- Molecular formula: (C2H4O)nC15H24O
- Molecular weight: 308.459 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: 100%
- Impurities (identity and concentrations): No data

Method

Target gene:
Histidine for Salmonella strains and Tryptophan for E. coli strains
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
E. coli WP2 uvr A
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
No data
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
0, 156, 313, 625, 1250, 2500, 5000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: Water
- Justification for choice of solvent/vehicle: The chemical was soluble in water
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
Water
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
9-aminoacridine
N-ethyl-N-nitro-N-nitrosoguanidine
other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (TA98, TA100; without S9); With S9: 2-Aminoanthraxene (All strains)
Details on test system and experimental conditions:
METHOD OF APPLICATION: Preincubation

DURATION
- Preincubation period: No data
- Exposure duration: No data
- Expression time (cells in growth medium): No data
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data

SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data

NUMBER OF REPLICATIONS: Duplicate with 3 plates/dose

NUMBER OF CELLS EVALUATED: No data

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data

OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data

OTHER: No data
Rationale for test conditions:
No data
Evaluation criteria:
The plates were observed for a dose dependent increase in the number of revertants/plate
Statistics:
No data

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium, other: TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
No data

Applicant's summary and conclusion

Conclusions:
Polyoxyethylene p-nonylphenyl ether failed to induce mutation in S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvr A in the presence and absence of S9 mix and hence is not likely to classify as a gene mutant in vitro.
Executive summary:

Gene mutation toxicity study was performed to evaluate the mutagenic nature of Polyoxyethylene p-nonylphenyl ether (EC name: Nonylphenol, ethoxylated). The test was performed as per the OECD guideline 471 using S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvr A with and without of S9 mix at dose levels of 0, 156, 313, 625, 1250, 2500, 5000 µg/plate. Concurrent solvent and positive controls were included in the study. Polyoxyethylene p-nonylphenyl ether failed to induce mutation in S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvr A in the presence and absence of S9 mix and hence is not likely to classify as a gene mutant in vitro.