p-benzoquinone dioxime

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:

weight of evidence

Study period:

1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented study carried out using scientifically valid protocols equivalent to relevant guidelines published in the peer reviewed literature, non-GLP; adapted for this endpoint according to REACH Regulation (EC) 1907/2006: Annex XI - section 1.1.2

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

p-benzoquinone dioxime

EC Number:

203-271-5

EC Name:

p-benzoquinone dioxime

Cas Number:

105-11-3

Molecular formula:

C6H6N2O2

IUPAC Name:

N-[(1Z,4Z)-4-(hydroxyimino)cyclohexa-2,5-dien-1-ylidene]hydroxylamine

Details on test material:

- Name of test material (as cited in study report): p-Quinone dioxime
- Other names: 1,4-benzoquinone dioxime ; p-benzoquinone dioxime ; CAS RN 105-11-3
- Analytical purity: Not stated, supplier Pfalz and Bauer
- Lot/batch No.: Not reported.
- Expiration date of the lot/batch: Not reported.

Method

Target gene:

Histidine and tryptophan locus

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 applicable

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Additional strain / cell type characteristics:

not applicable

Cytokinesis block (if used):

Not applicable.

Metabolic activation:

with and without

Metabolic activation system:

rat liver S9

Test concentrations with justification for top dose:

Main test (plate incorporation method): All strains: series of half log doses up to 10000 µg/plate or the limit of solubility (i.e. up to 10 mg/plate or solubility limit, whichever lower).

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Not reported. It can be presumed by applicant assessment that a standard Ames test vehicle would be used, water or DMSO are typical.
- Justification for choice of solvent/vehicle: Not reported

Controls

Untreated negative controls:

yes

Remarks:

Not specified. Concurrent Negative Controls were run.

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

not specified

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Expression time (cells in growth medium): 48h at 37 degrees Celsius

NUMBER OF REPLICATIONS: 3

Statistics:

A statistical analysis was not performed or reported.

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

The precise strain/strains which yielded positive results: within the standard Ames et al. (1975) protocol was not indicated per se in the report. Merely that positive with one of either TA98, TA100, TA1535 and/or TA1537 was observed; i.e. "Conclusion based on all Salmonella strains and activation systems." and/or "Conclusions based on E coli responses.", respectively.

Applicant's summary and conclusion

Conclusions:

Interpretation of results:
positive
Under the conditions of this study the test item was considered to be mutagenic in the presence and absence of S9 activation. The test item induced gene mutations in the strains of S. typhimurium and E. coli utilzed.

Executive summary:

The study was performed using methods equivalent or similar to the requirements of OECD Guideline 471, to evaluate the potential mutagenicity of sixty substances in an inter laboratory study which included the test item. The method used was the plate-incubation method bacterial reverse mutation assay using Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2 uvrA strains in both the presence and absence of S-9 mix. The test item was tested up to 10000 µg/plate or the limit of solubility, whichever lower. The vehicle was not specified. Appropriate numbers of positive control substances with and without metabolic activation (rat liver S9) were included and randomly allocated concurrent true negative controls and concurrent vehicle controls. Under the conditions of the study, the test item gave a positive, i.e. mutagenic response in Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2 uvrA strains in either the presence or absence of S-9 mix.