Naphthalene-1,5-diol

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:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: only as secondary citation available: guideline study and GLP

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Naphthalene-1,5-diol

EC Number:

201-487-4

EC Name:

Naphthalene-1,5-diol

Cas Number:

83-56-7

Molecular formula:

C10H8O2

IUPAC Name:

naphthalene-1,5-diol

Test material form:

other: solid

Details on test material:

content : >99.9 %
batch no.820211/01

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Additional strain / cell type characteristics:

other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Metabolic activation system:

Liver S9-fraction fromphenobarbital/beta-naphthoflavone-induced rats was used as exogenous metabolic activation system

Test concentrations with justification for top dose:

Experiment I: 33-5000 µg/plate without and with S9-mix
Experiment II: 10-5000 µg/plate without and with S9-mix

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

other: in accordance with the OECD guideline

Positive control substance:

not specified

Details on test system and experimental conditions:

Test concentrations were based on the level of toxicity in a preliminary toxicity test with strains TA98, TA100, TA102, TA
1535 and TA 1537 both without and with S9-mix. Toxicity was evaluated for 8 concentrations up to the prescribed
maximum concentration of 5000 μg/plate on the basis of a reduction in the number of revertant colonies
and/or thinning of the bacterial background lawn.

Since in this pre-experiment evaluable plates were obtained for five concentrations or more in all strains used
the pre-experiment is reported as experiment I.
Experiment I was performed with the direct plate incorporation method, incubation time: 48 h, with and without S9-mix
Experiment II with the pre-incubation method, incubation time: 48 h, with and without S9-mix
Negative and positive controls were in accordance with the OECD guideline.

Evaluation criteria:

details not given , in accordance with the OECD Guideline

Statistics:

no data

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

other: yes, but details not given

Additional information on results:

Precipitation of 1,5-naphthalenediol was observed
in experiment I at 5000 μg/plate and in
experiment II at 2500 and 5000 μg/plate both without and with S9-mix.
Toxic effects
In experiment I without S9-mix toxic effects were observed at 2500 μg/plate for TA102 and
TA1535 and at 5000 μg/plate for TA98, TA100 and TA1537; with S9-mix at 5000 μg/plate
for TA100, TA102 and TA1535.
In experiment II without S9-mix toxicity was reported at
1000 μg/plate for TA98 and TA100 and at 2500 μg/plate for TA102; with S9-mix at 1000
μg/plate for TA102 and at 2500 μg/plate TA98.

Both in experiment I and II no biological relevant increase in revertant colonies was seen in
any of the five tester strains following treatment with 1,5-naphthalenediol neither in the
absence nor in the presence of S9-mix.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

under the experimental conditions used 1,5 -naphthalenediol was not genotoxic
(mutagenic) in the gene mutation tests in bacteria

Executive summary:

SCCS (2010) reported

1,5-Naphthalenediol was investigated for the induction of gene mutations in Salmonella typhimurium (Ames test) using TA98, TA100, TA102, TA1535 and TA1537 and concentrations up to 5000 µg/plate in the presence and in the absence of a metabolic activation system. Both in experiment I and II no biological relevant increase in revertant colonies was seen in any of thefore tester strains following treatment with 1,5-naphthalenediol neither in the absence nor in the presenceof S9-mix.

Thus, under the experimental conditions used 1,5 -naphthalenediol was not genotoxic (mutagenic) in the gene mutation tests in bacteria