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EC number: 246-758-8 | CAS number: 25251-42-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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
- 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 peer reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Salmonella Mutagenicity Tests: V. Results from the Testing of 311 Chemicals
- Author:
- Errol Zeiger, Beth Anderson, Steve Haworth, Timothy Lawlor, and Kristien Mortelmans
- Year:
- 1 992
- Bibliographic source:
- Environmental and Molecular Mutagenesis Volume 19, Supplement 21: 2-141 (1992)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Procedure as described by Haworth et al 1983 with slight modification
- Principles of method if other than guideline:
- Preincubation assay was performed to evaluate the mutagenic nature of the test compound 4-(2-Naphthylamino)phenol
- GLP compliance:
- not specified
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- p-(2-naphthylamino)phenol
- EC Number:
- 202-248-7
- EC Name:
- p-(2-naphthylamino)phenol
- Cas Number:
- 93-45-8
- IUPAC Name:
- 4-(2-naphthylamino)phenol
- Details on test material:
- - Name of test material: 4-(2-Naphthylamino)phenol
- Molecular formula: C16H13NO
- Molecular weight: 235.285 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: appr. 88%
- Impurities (identity and concentrations): No data
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: 4-(2-Naphthylamino)phenol
- IUPAC name: 4-(2-naphthylamino)phenol
- Molecular formula: C16H13NO
- Molecular weight: 235.285 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: appr. 88%
- Impurities (identity and concentrations): 12%
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 100, TA1535, TA 1537, TA 97 and TA98
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- 10% and 30% hamster liver S9 and 10% and 30% rat liver S9
- Test concentrations with justification for top dose:
- 0, 0.3, 1, 3, 10, 33, 66, 100, 166, 333 or 666 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: No data available
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 4-nitro-o-phenylenediamine, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Preincubation
DURATION
- Preincubation period: 20 mins
- Exposure duration: 2 days
- Expression time (cells in growth medium): 2 days
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available
SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available
NUMBER OF REPLICATIONS: No data available
NUMBER OF CELLS EVALUATED: No data available
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data available
OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other: No data available
OTHER: No data available - Rationale for test conditions:
- No data
- Evaluation criteria:
- The plates were observed for a dose dependent increase in the number of Histidine- independent (his+) colonies.
Evaluations were made at both the individual trial and chemical levels.
Individual trials were judged mutagenic (+), weakly mutagenic (+ W), questionable (?), or nonmutagenic (-), depending on the magnitude of the increase in his+ revertants, and the shape of the dose response. A trial was considered questionable (?) if the dose-response was judged insufficiently high to support a call of “+ W”, if only a single dose was elevated over the control, or if a weak increase was not dose-related. The distinctions between a questionable response and a nonmutagenic or weakly mutagenic response, and between a weak mutagenic response and mutagenic response are highly subjective. It was not necessary for a response to reach two-fold over background for a trial to be judged mutagenic.
A chemical was judged mutagenic (+) or weakly mutagenic (+W) if it produced a reproducible, dose-related response over the solvent control, under a single metabolic activation condition, in replicate trials. A chemical was judged questionable (?) if the results of individual trials were not reproducible, if increases in his+ revertants did not meet the criteria for a “+W” response, or if only single doses produced increases in his+ revertants in repeat trials. Chemicals were judged nonmutagenic (-) if they did not meet the criteria for a mutagenic or questionable response. - Statistics:
- Mean, SEM
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 100, TA1535, TA 1537, TA 97 and TA98
- 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 available
- Remarks on result:
- other: No mutagenic potential
Any other information on results incl. tables
Table: Results for the test chemical 4-(2-Naphthylamino)phenol
Dose (µg/plate) |
TA100 |
|||||||||
NA |
10% HLI |
30% HLI |
10% RLI |
30% RLI |
||||||
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
|
0 |
91 |
5.4 |
89 |
6.2 |
139 |
5.6 |
102 |
9.0 |
154 |
4.4 |
0.3 |
125 |
5.8 |
|
|
|
|
|
|
|
|
1 |
104 |
10.0 |
|
|
|
|
|
|
|
|
3 |
91 |
2.9 |
82 |
7.3 |
|
|
98 |
6.7 |
|
|
10 |
85 |
0.7 |
105 |
21.6 |
134 |
15.7 |
108 |
17.0 |
181 |
8.9 |
33 |
46s |
15.5 |
134 |
3.5 |
159 |
13.9 |
97 |
6.1 |
156 |
5.1 |
66 |
|
|
|
|
|
|
|
|
|
|
100 |
|
|
113 |
7.4 |
124 |
14.7 |
90 |
5.1 |
149 |
7.9 |
166 |
|
|
83 |
3.0 |
|
|
94 |
6.8 |
|
|
333 |
|
|
|
|
96 |
3.5 |
|
|
73 |
2.5 |
666 |
|
|
|
|
21s |
9.4 |
|
|
0s |
0.0 |
Positive control |
352 |
7.2 |
681 |
36.9 |
612 |
23.9 |
414 |
7.2 |
550 |
31.4 |
Dose (µg/plate) |
TA1535 |
|||||||||
NA |
10% HLI |
30% HLI |
10% RLI |
30% RLI |
||||||
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
|
0 |
22 |
3.8 |
14 |
4.5 |
12 |
0.3 |
12 |
1.8 |
12 |
0.9 |
0.3 |
23 |
2.3 |
|
|
|
|
|
|
|
|
1.0 |
25 |
2.7 |
|
|
|
|
|
|
|
|
10 |
23 |
1.8 |
11 |
2.3 |
13 |
2.1 |
15 |
3.0 |
11 |
0.9 |
33 |
16 |
1.8 |
15 |
1.5 |
11 |
2.0 |
12 |
1.5 |
10 |
1.2 |
66 |
|
|
|
|
|
|
|
|
|
|
100 |
|
|
13 |
2.2 |
13 |
1.9 |
11 |
2.1 |
13 |
2.2 |
166 |
|
|
12 |
2.2 |
|
|
8 |
0.9 |
|
|
333 |
|
|
|
|
13 |
2.7 |
|
|
7 |
2.6 |
666 |
|
|
|
|
|
|
|
|
|
|
Positive control |
301 |
18.6 |
269 |
22.6 |
400 |
31.3 |
165 |
9.2 |
122 |
17.9 |
Dose (µg/plate) |
TA1537 |
|||||
NA |
10% HLI |
30% HLI |
||||
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
|
0 |
10 |
2.2 |
10 |
1.2 |
12 |
0.9 |
0.3 |
9 |
0.0 |
|
|
|
|
1 |
8 |
3.9 |
|
|
|
|
3 |
7 |
1.2 |
10 |
3.2 |
9 |
0.3 |
10 |
5 |
1.2 |
8 |
0.9 |
9 |
2.2 |
33 |
6 |
2.1 |
10 |
0.9 |
9 |
2.2 |
66 |
|
|
|
|
|
|
100 |
|
|
11 |
1.9 |
9 |
2.0 |
166 |
|
|
|
|
|
|
333 |
|
|
6 |
2.6 |
10 |
1.3 |
666 |
|
|
|
|
|
|
Positive control |
397 |
27.1 |
46 |
4.0 |
61 |
0.6 |
Dose (µg/plate) |
TA97 |
|||||||||
NA |
10% HLI |
30% HLI |
10% RLI |
30% RLI |
||||||
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
|
0 |
189 |
9.6 |
190 |
20.5 |
167 |
12.3 |
193 |
10.8 |
174 |
11.7 |
0.3 |
198 |
2.3 |
|
|
|
|
|
|
|
|
1 |
195 |
3.5 |
|
|
|
|
|
|
|
|
3 |
202 |
7.1 |
205 |
8.0 |
173 |
13.6 |
193 |
0.7 |
174 |
4.9 |
10 |
175 |
12.0 |
194 |
5.0 |
156 |
14.3 |
204 |
9.0 |
186 |
12.3 |
33 |
184 |
12.1 |
170 |
3.5 |
201 |
7.0 |
208 |
4.5 |
182 |
13.3 |
66 |
|
|
|
|
|
|
|
|
|
|
100 |
|
|
121 |
13.0 |
189 |
9.3 |
190 |
16.5 |
159 |
23.1 |
166 |
|
|
67s |
7.4 |
|
|
79 |
6.6 |
|
|
333 |
|
|
|
|
12 |
2.6 |
|
|
14 |
2.3 |
666 |
|
|
|
|
|
|
|
|
|
|
Positive control |
433 |
9.6 |
332 |
11.3 |
343 |
18.3 |
316 |
6.7 |
351 |
12.2 |
Dose (µg/plate) |
TA98 |
|||||||||
NA |
10% HLI |
30% HLI |
10% RLI |
30% RLI |
||||||
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
Mean |
SEM |
|
0 |
14 |
2.6 |
27 |
2.2 |
23 |
3.0 |
34 |
3.1 |
24 |
1.3 |
0.3 |
17 |
3.5 |
|
|
|
|
|
|
|
|
1 |
18 |
3.8 |
|
|
|
|
|
|
|
|
3 |
16 |
2.5 |
37 |
3.4 |
|
|
28 |
1.5 |
|
|
10 |
14 |
0.6 |
39 |
0.3 |
31 |
5.5 |
21 |
2.7 |
24 |
1.2 |
33 |
13 |
1.5 |
31 |
2.5 |
25 |
3.0 |
15 |
2.3 |
22 |
1.5 |
66 |
|
|
|
|
|
|
|
|
|
|
100 |
|
|
22 |
1.7 |
21 |
1.7 |
19 |
2.5 |
17 |
1.0 |
166 |
|
|
21 |
3.5 |
|
|
18 |
1.5 |
|
|
333 |
|
|
|
|
12 |
1.8 |
|
|
12 |
1.3 |
666 |
|
|
|
|
9 |
0.9 |
|
|
6 |
1.2 |
Positive control |
401 |
33.4 |
392 |
31.0 |
376 |
29.1 |
193 |
5.8 |
164 |
9.8 |
Applicant's summary and conclusion
- Conclusions:
- 4-(2-Naphthylamino)phenol did not induce gene mutation in the Salmonella typhimurium tester strains TA 100, TA1535, TA 1537, TA 97 and TA98 in the presence and absence of S9 metabolic activation system and hence is negative for gene mutation in vitro.
- Executive summary:
Preincubation assay was performed to evaluate the mutagenic nature of the 4-(2-Naphthylamino)phenol. The study was performed as described by Haworth et al 1983 with slight modification. The study involved the use of test chemical dose levels of 0, 0.3, 1, 3, 10, 33, 66, 100, 166, 333 or 666 µg/plate and Salmonella typhimurium strains TA 100, TA1535, TA 1537, TA 97 and TA98 in the presence and absence of S9 metabolic activation system. 4-(2-Naphthylamino)phenol did not induce gene mutation in the Salmonella typhimurium tester strains in the presence and absence of S9 metabolic activation system and hence is negative for gene mutation in vitro.
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