1,5-dinitronaphthalene

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

(Q)SAR

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986 and 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

The analogue approach was chosen as a suitable method for read-across since the target molecule, 1,5-dinitronapthalene, was not found in any of the existing chemical categories searchable in the following databases -US EPA, OECD, eChemPortal and OECD QSAR Toolbox.
Following that decision, the selection of suitable analogues for the molecule of interest involved the use of structural similarity analysis. These analyses were conducted in the ChemIDplus portal and relied on a quantitative measurement (scored between 0 and 1) after the evaluation of molecules with a structural similarity higher than 95% by the Tanimoto index.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

Guideline not specified, summary data from read-across report. These data were peer-reviewed and considered acceptable.

GLP compliance:

not specified

Remarks:

Read-across endpoint is taken from a collection of data - the GLP compliance is not specified. Studies were conducted in 1986 and 1994.

Type of assay:

other: read-across to multiple studies: In vitro Ames; In Vivo test Drosophilia; Bacterial mutagenicity ISSSTY

Test material

Test material information

Constituent 1

Reference substance name:

1-nitronaphthalene

EC Number:

201-684-5

EC Name:

1-nitronaphthalene

Cas Number:

86-57-7

Molecular formula:

C10H7NO2

IUPAC Name:

1-nitronaphthalene

Test material form:

solid: crystalline

Specific details on test material used for the study:

Read-across molecule, test material specifics are not available.

Method

Target gene:

Not specified

Species / strain

Species / strain / cell type:

bacteria, other: bacteria, strain not specified

Additional strain / cell type characteristics:

not specified

Metabolic activation:

not specified

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

not specified

Remarks:

Data from read-across summary, controls not specified

Details on test system and experimental conditions:

Results taken from read-across to multiple studies.

Results and discussion

Test results

Key result

Species / strain:

bacteria, other: not specified

Metabolic activation:

not specified

Genotoxicity:

positive

Remarks:

Read-across, detail not available

Cytotoxicity / choice of top concentrations:

not specified

Remarks:

Read-across, detail not available

Vehicle controls validity:

not specified

Remarks:

Read-across, detail not available

Untreated negative controls validity:

not specified

Remarks:

Read-across, detail not available

Positive controls validity:

not specified

Remarks:

Read-across, detail not available

Remarks on result:

other: Positive results in vitro were supported by a positive result in vivo, by a somatic cell test, is considered as evidence to classify when relying on in silico data. Therefore, it is acceptable to classify the substance of interest as a Mutagen Category 2.

Any other information on results incl. tables

Positive in vitro data in the bacterial system (Ames test) is available from the searchable databases for both target and source substances. Peer-reviewed, non-standardised data were considered acceptable for the current evaluation (original publications of Mortelmans et al., 1986 and Mersch-Sunderman et al., 1994).

In vivo mutagenicity potential was also reported in somatic cells of Drosophila for both target and source molecules. The results of the “Wing somatic mutation and recombination”- SMART test in Drosophila revealed that both compounds can cause genetic toxicity by eliciting an increased incidence of homologous somatic recombination. Specifically, 1-nitro-naphthalene was the compound with the strongest genotoxicity and 1,5-dinitronapthalene approximately 333 times less potent than this compound. (original data, peer-reviewed studies (standard), authors Delgado-Rodriguez et al., 1995 available at HSDB database)

The fact that positive results in vitro were supported by a positive result in vivo, by a somatic cell test, is considered by ECHA as enough evidence to lead to classification when the assessment relies upon in silico data. Therefore, it is acceptable to classify the substance of interest as a Mutagen Category 2.

Applicant's summary and conclusion

Conclusions:

Positive in vitro data in the bacterial system (Ames test) is available from the searchable databases for both target and source substances. Peer-reviewed, non-standardised data were considered acceptable for the current evaluation (original publications of Mortelmans et al., 1986 and Mersch-Sunderman et al., 1994).
In vivo mutagenicity potential was also reported in somatic cells of Drosophila for both target and source molecules. The results of the “Wing somatic mutation and recombination”- SMART test in Drosophila revealed that both compounds can cause genetic toxicity by eliciting an increased incidence of homologous somatic recombination. Specifically, 1-nitro-naphthalene was the compound with the strongest genotoxicity and 1,5-dinitronapthalene approximately 333 times less potent than this compound. (original data, peer-reviewed studies (standard), authors Delgado-Rodriguez et al., 1995 available at HSDB database)
The fact that positive results in vitro were supported by a positive result in vivo, by a somatic cell test, is considered by ECHA as enough evidence to lead to classification when the assessment relies upon in silico data. Therefore, it is acceptable to classify the substance of interest as a Mutagen Category 2.

Executive summary:

Positive in vitro data in the bacterial system (Ames test) is available from the searchable databases for both target and source substances. Peer-reviewed, non-standardised data were considered acceptable for the current evaluation (original publications of Mortelmans et al., 1986 and Mersch-Sunderman et al., 1994).

In vivo mutagenicity potential was also reported in somatic cells of Drosophila for both target and source molecules. The results of the “Wing somatic mutation and recombination”- SMART test in Drosophila revealed that both compounds can cause genetic toxicity by eliciting an increased incidence of homologous somatic recombination. Specifically, 1-nitro-naphthalene was the compound with the strongest genotoxicity and 1,5-dinitronapthalene approximately 333 times less potent than this compound. (original data, peer-reviewed studies (standard), authors Delgado-Rodriguez et al., 1995 available at HSDB database)

The fact that positive results in vitro were supported by a positive result in vivo, by a somatic cell test, is considered by ECHA as enough evidence to lead to classification when the assessment relies upon in silico data. Therefore, it is acceptable to classify the substance of interest as a Mutagen Category 2.