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EC number: 202-049-5 | CAS number: 91-20-3
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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:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study, basic data given, part of a comprehensive test programme
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 986
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 981
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- No guideline stated, but study was conducted according to Ames et al. (1975), Mutat. Res. 31, 347-364; comparable to guideline study and in accordance with OECD Guideline 471
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Naphthalene
- EC Number:
- 202-049-5
- EC Name:
- Naphthalene
- Cas Number:
- 91-20-3
- Molecular formula:
- C10H8
- IUPAC Name:
- naphthalene
- Details on test material:
- - Name of test material (as cited in study report): naphthalene (obtained from Fisher Scientific)
- Physical state: white crystalline powder
- Analytical purity: 99.8%
Constituent 1
Method
- Target gene:
- his¯
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from livers of Aroclor 1254 induced male Sprague-Dawley rats or Syrian hamsters
- Test concentrations with justification for top dose:
- 0 (solvent control), 0.3, 1.0, 3.3, 10.0, 33.0, 100.0 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: no data
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: without S9 mix: TA98 4-nitro-o-phenylenediamine, TA100 and TA1535 sodium azide, TA1537 9-aminoacridine; with S9 mix: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min at 37°C
- Exposure duration: 48 h
- Expression time (cells in growth medium): 48 h at 37°C
NUMBER OF REPLICATIONS: triplicate plating
DETERMINATION OF CYTOTOXICITY
- Method: no data - Evaluation criteria:
- Mutagenic response: a dose-related, reproducible increase in the number of revertants over background;
nonmutagenic response: when no increase in the number of revertants was elicited by the chemical;
questionable response: when there was an absence of a clear-cut dose-related increase in revertants,
when the dose related increases in the number of revertants were not reproducable,
when the response was of insufficient magnitude to support a determination of mutagenicity. - Statistics:
- Mean and standard error of the mean of replicate plates were calculated.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- in tests with the highest concentrations, toxicity was observed.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Detailed results of the NTP Ames test of naphthalene
Data of both experiments are reported. Individual strain data is presented as mean ± standard error. Abbreviations are noted below the tables. Study number is 471098. Study was completed in 1981.
Strain: TA1535
Dose |
No Activation |
No Activation |
10% HLI |
10% HLI |
10% RLI |
10% RLI |
||||||
(Negative) |
(Negative) |
(Negative) |
(Negative) |
(Negative) |
(Negative) |
|||||||
Protocol |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
||||||
µg/Plate |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
0 (solvent control) |
22 |
1.5 |
19 |
2.6 |
11 |
2.3 |
8 |
0.6 |
9 |
0.6 |
12 |
2.4 |
0.3 |
24 |
3.1 |
||||||||||
1 |
21 |
3 |
26 |
2.7 |
10 |
3.3 |
11 |
2.9 |
13 |
1.2 |
16 |
1.5 |
3.3 |
22 |
5.2 |
23 |
2.3 |
10 |
0.9 |
11 |
3.8 |
9 |
0.7 |
10 |
1.7 |
10 |
30 |
2.6 |
20 |
1.2 |
12 |
0.6 |
11 |
0.3 |
8 |
0.7 |
10 |
2.6 |
33 |
20s |
1.2 |
15 |
2.3 |
13 |
1 |
11 |
1.7 |
11 |
1.5 |
13 |
1.2 |
100 |
15t |
3.5 |
6s |
1.9 |
10s |
3.2 |
13s |
3.4 |
11s |
2.9 |
||
Positive Control |
1258 |
18.8 |
687 |
6.4 |
126 |
1.7 |
75 |
8.9 |
63 |
8 |
48 |
1.9 |
Strain: TA100
Dose |
No Activation |
No Activation |
10% HLI |
10% HLI |
10% RLI |
10% RLI |
||||||
(Negative) |
(Negative) |
(Negative) |
(Negative) |
(Negative) |
(Negative) |
|||||||
Protocol |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
||||||
µg/Plate |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
0 (solvent control) |
143 |
4.5 |
141 |
4.2 |
143 |
11.9 |
128 |
6.2 |
144 |
2.4 |
137 |
8.2 |
0.3 |
121 |
3.5 |
||||||||||
1 |
146 |
5.8 |
124 |
3.6 |
143 |
13.2 |
115 |
7.9 |
130 |
2.7 |
143 |
16 |
3.3 |
124 |
12 |
117 |
8.5 |
155 |
4.9 |
135 |
2.4 |
133 |
13.2 |
133 |
5.9 |
10 |
145 |
5.8 |
113 |
6.2 |
140 |
3.5 |
118 |
9.8 |
135 |
8.7 |
121 |
6.6 |
33 |
141s |
9.4 |
113 |
5.1 |
147 |
5.7 |
133 |
6.8 |
142 |
6.6 |
121 |
7.3 |
100 |
t |
141s |
2 |
145s |
9 |
104s |
0.6 |
127s |
5.4 |
|||
Positive Control |
1636 |
45.5 |
801 |
28.7 |
2534 |
77.9 |
754 |
19.2 |
1074 |
13.2 |
792 |
26.4 |
Strain: TA98
Dose |
No Activation |
No Activation |
10% HLI |
10% HLI |
10% RLI |
10% RLI |
||||||
(Negative) |
(Negative) |
(Negative) |
(Negative) |
(Negative) |
(Negative) |
|||||||
Protocol |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
||||||
ug/Plate |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
0 (solvent control) |
14 |
3.8 |
17 |
1 |
35 |
4.8 |
20 |
3.1 |
29 |
4.1 |
23 |
0.3 |
0.3 |
12 |
2.2 |
||||||||||
1 |
15 |
2.2 |
17 |
1.5 |
30 |
2.6 |
29 |
2.1 |
27 |
1.8 |
23 |
2.2 |
3.3 |
22 |
2.3 |
12 |
2.6 |
42 |
5.5 |
21 |
1.9 |
32 |
1.7 |
24 |
0.7 |
10 |
16 |
3.3 |
12 |
2.6 |
32 |
4.2 |
26 |
1.2 |
25 |
2.6 |
21 |
0.9 |
33 |
19s |
2.5 |
12 |
3.2 |
32 |
3.1 |
21 |
1.2 |
29 |
1.9 |
24 |
2.8 |
100 |
14s |
0.3 |
34s |
1.5 |
23 |
2.4 |
22s |
1.2 |
24 |
1.2 |
||
Positive Control |
1772 |
9.6 |
1072 |
40.3 |
2064 |
71.4 |
183 |
10.1 |
982 |
43.1 |
176 |
16.6 |
Strain TA1537
Dose |
No Activation |
No Activation |
10% HLI |
10% HLI |
10% RLI |
10% RLI |
||||||
(Negative) |
(Negative) |
(Negative) |
(Negative) |
(Negative) |
(Negative) |
|||||||
Protocol |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
||||||
ug/Plate |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
0 (solvent control) |
8 |
1.8 |
8 |
1.9 |
10 |
1.2 |
6 |
2.4 |
11 |
3.8 |
10 |
2.3 |
0.3 |
7 |
1.2 |
||||||||||
1 |
8 |
0.6 |
5 |
0.6 |
11 |
1.2 |
8 |
0.3 |
10 |
0.9 |
8 |
0.7 |
3.3 |
7 |
1.5 |
9 |
0.6 |
9 |
3.2 |
7 |
0.9 |
9 |
0.9 |
9 |
0.9 |
10 |
8 |
0.7 |
9 |
1.5 |
12 |
2 |
10 |
1.5 |
8 |
1.7 |
5 |
2.2 |
33 |
6s |
2 |
4 |
0.9 |
12 |
1.5 |
10 |
1.5 |
10 |
1.9 |
7 |
1.5 |
100 |
t |
10s |
1 |
5s |
0.6 |
5s |
1.9 |
4s |
0.6 |
|||
Positive Control |
1010 |
39.4 |
185 |
12 |
205 |
22.1 |
77 |
5.3 |
87 |
5.2 |
86 |
2.9 |
Abbreviations:
RLI = induced male Sprague Dawley rat liver S9
HLI = induced male Syrian hamster liver S9
s = slight toxicity; p = precipitate; x = slight toxicity and precipitate; t = toxic; c = contamination
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
In a reverse gene mutation assay in bacteria according to Ames (1975) using four strains of S. typhimurium (TA 97, TA 98, TA 100, TA 1535, and TA 1537), naphthalene was tested negative at concentrations of 0.3, 1.0, 3.3, 10, 33, and 100 µg/plate in the presence and absence of mammalian metabolic activation (S9 mix from Arochlor 1254 induced rat and hamster liver). At the highest concentration some cytotoxicity was observed. Under the conditions of this test, naphthalene is not mutagenic to bacteria in vitro.
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