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EC number: 201-983-0 | CAS number: 90-30-2
- 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 mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- yes
- Remarks:
- Metabolic activation with non-induced mouse liver S9
- Principles of method if other than guideline:
- The procedure was a modification of that reported by Clive and Spector (1975). Briefly, rapidly growing cells were cleansed of spontaneous Tk-/- mutants by growing them in a medium containing thymidine hypoxanthine, methotrexate and glycine (THMG). Only cells producing the enzyme thymidine kinase can utilize the exogenous thymidine from the medium and grow. Study was performed before actual guideline was established.
- GLP compliance:
- not specified
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- N-1-naphthylaniline
- EC Number:
- 201-983-0
- EC Name:
- N-1-naphthylaniline
- Cas Number:
- 90-30-2
- Molecular formula:
- C16H13N
- IUPAC Name:
- N-phenylnaphthalen-1-amine
- Details on test material:
- - Name of test material (as cited in study report): N-Phenyl-Alpha-Naphtylamine
- Substance type: red-brown pellets
- Physical state: solid
- Analytical purity: no data
- Other: Source: United States Air Force
Constituent 1
Method
- Target gene:
- thymidine kinase locus
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- Non-induced mouse liver S9-mix
- Test concentrations with justification for top dose:
- -S9: 0.5, 5.0, 10.0, 25.0 µg/ml
+S9: 0.005, 0.01, 0.05, 0.1 µg/ml - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: ethylmethanesulfonate (-S9); dimethylnitrosamine (+S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 5 hours
- Expression time (cells in growth medium): 3 days
- Selection time (if incubation with a selection agent): 10 days
- Fixation time (start of exposure up to fixation or harvest of cells): 13 days
SELECTION AGENT (mutation assays): BUdR (5' bromodeoxyuridine)
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: other: loss in growth potential, plating efficiency (cell survival) - Statistics:
- Data analysis:
A mutation frequency was determined for each test dose by dividing the number of mutants/ml by the number of surviving cells/ml (adjusted to 10e-4) as indicated by plating efficiency.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Concentration showing toxic effects was chosen as highest conentration tested tested was chosen
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- ADDITIONAL INFORMATION ON CYTOTOXICITY:
The solubility, toxicity and doses for the test chemical were determined prior to screening. The effect of the chemical on cell survival was determined by exposing the cells to a wide range of chemical concentrations in complete growth medium. Toxicity was measured as loss in growth potential of the cells induced by a five-hour exposure to the chemical. Four doses were selected from the range of concentrations by using the highest dose that showed no loss in growth potential as the penultimate dose and by bracketing this with one higher and two lower doses. Toxicity produced by chemical treatment was monitored during the experiment.
Any other information on results incl. tables
Mouse lymphoma mutagenicity assay:
|
Day 1 count |
Day 3 count |
?GS |
%GS |
MC |
VC |
%CE |
GF |
MF(10e-4) |
-S9 |
|
|
|
|
|
|
|
|
|
Control |
1.5 |
11.1 |
9.6 |
100 |
89 |
191 |
100 |
100 |
0.5 |
EMS |
1.6 |
2.3 |
0.7 |
7 |
288 |
7 |
4 |
0.3 |
41.1 |
PANA (µg/ml) |
|
|
|
|
|
|
|
|
|
0.5 |
3.1 |
11.2 |
8.1 |
84 |
68 |
214 |
112 |
94 |
0.3 |
5.0 |
2.7 |
8.6 |
5.9 |
61 |
5 |
300 |
157 |
95 |
0.02 |
10.0 |
2.6 |
10.9 |
8.3 |
86 |
50 |
202 |
105 |
122 |
0.3 |
25.0 |
3.4 |
12.4 |
9.0 |
93 |
57 |
215 |
112 |
104 |
0.3 |
+S9 |
|
|
|
|
|
|
|
|
|
Control |
1.1 |
7.2 |
6.1 |
100 |
58 |
229 |
100 |
100 |
0.3 |
DMN |
1.5 |
2.7 |
0.2 |
3 |
184 |
8 |
3 |
0.9 |
2.3 |
PANA (µg/ml) |
|
|
|
|
|
|
|
|
|
0.005 |
3.3 |
17.8 |
14.5 |
246 |
8 |
56 |
69 |
170 |
0.1 |
0.01 |
3.1 |
15.6 |
12.5 |
212 |
3 |
58 |
72 |
152 |
0.05 |
0.05 |
2.8 |
6.5 |
3.7 |
62 |
32 |
70 |
86 |
54 |
0.5 |
0.1 |
0.9 |
1.7 |
0.8 |
14 |
6 |
36 |
44 |
6 |
0.2 |
Day 1 and 3 counts: Expression day cell counts (x10e6)
?GS: Represents cell population growth during expression. The value is obtained by subtracting the Day 1 counts from the terminal day counts.
%GS: Percent suspension growth is obtained by expressing the?GS values for treated cells as a percent of the?GS for the negative controls.
MC: Mutant counts. The total number of colonies counted in the BUdR plates.
VC: Viable counts. The total number of colonies counted in the VC plates.
%CE: Cloning efficiency. Obtained by expressing the VC in treated cultures as a percent of the VC in negative controls.
GF: Growth factor. %GS x %CE / 100
MF (x10e-4): Mutation frequency. MC / VC x 10e-4
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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