4-Nonylphenol, branched, ethoxylated

Genetic toxicity: in vitro

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

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

Test material information

Constituent 1

Reference substance name:

Nonylphenol, ethoxylated

EC Number:

500-024-6

EC Name:

Nonylphenol, ethoxylated

Cas Number:

9016-45-9

Molecular formula:

(C2-H4-O)mult-C15-H24-O

IUPAC Name:

Nonylphenol, ethoxylated

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 / strain

Species / strain 1

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 2

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 results

Test results 1

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

Test results 2

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.