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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The test article was not mutagenic and not clastogenic in various in vitro studies.
Link to relevant study records
- 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
- 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
- Target gene:
- thymidine kinase locus
- 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
- 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. - 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. - Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented publication which meets basic scientific principles.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- No information if duplicate cultures were performed.
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
- Target gene:
- not applicable
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9
- Test concentrations with justification for top dose:
- -S9: 2.99 - 29.9 µg/ml
+S9: 1.49 - 19.9 µg/ml - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without S9: 1.0 and 5.0 µg/ml, respectively
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with S9: 50 µg/ml
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 8 hours (-S9); 2 hours (+S9)
- Expression time (cells in growth medium): 8 hours (exposure time; -S9); 8 hours (+S9)
- Fixation time (start of exposure up to fixation or harvest of cells): 10 - 10.5 hours (-S9); 12 hours (+S9)
SPINDLE INHIBITOR (cytogenetic assays): colcemid
STAIN (for cytogenetic assays): 5 % Giemsa
NUMBER OF CELLS EVALUATED: 200 per dose
DETERMINATION OF CYTOTOXICITY
- Method: other: loss of confluency of cell monolayer
OTHER EXAMINATIONS:
- Determination of polyploidy: only when it seemed excessive
- Determination of endoreplication: only when it seemed excessive
- Other: categories of chromosomal aberration: simple (chromatid gap, break, fragment and deletion; chromosome gap, break, double minutes), complex (interstitial deletions, triradials, quadriradials, rings, dicentric chromosomes); other aberrations (pulverized chromosomes or cells with greater than 10 aberrations). Chromatid and chromosome gaps were recorded but were not used in the analysis, polyploidy or endoreduplication were not included in the totals or in the statistical analysis. - Evaluation criteria:
- A positive response at a single dose was designated "+W", weak evidence for clastogenicity. If there was a strong trend as the result of a large increase in aberrations at a single dose only,the result was designated as "+W*". A test was designated "+" if at least two doses gave significantly increased responses. As a general rule, a test was repeated to confirm a positive result if there was one or more elevated points, if toxicity was too great, or if the controls did not give the expected responses. When combining the conclusions from 2 or more trials, more weight was given to the trials(s) that had a more appropriate experimental design, based on dose range and harvest time. Factors such as a reduced number of cells scored or a high solvent control usually reduced the weight given to a result. In general, in combining the conclusions of 2 trials, a chemical was designated as "+" if both trials were "+", or "+W" and "+" or "+" and "?". A "+W" and "?" were judged to be a "+W". A "+" response that was not repeatable gave rise to a "?", whereas a "+W" or "?" response that was not repeatable was considered "-".
- Statistics:
- A binomial sampling assumption as described by Margolin et al. (1983) was used to examine absolute increases in aberrations over solvent control levels at each dose. The P values were adjusted by Dunnett's method to take into account the multiple dose comparisons. Only the "total" percent cells with aberrations were analyzed, and a positive response was defined as one for which the adjusted P value was <0.05.
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- Highest dose was chosen to allow sufficient numbers of M2 cells for analysis at time of harvest.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Endpoint:
- in vitro gene mutation study in bacteria
- 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
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Dose and identity of positive control substance not reported
- Principles of method if other than guideline:
- Experiment performed before actual guideline was established.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- His-operon
- Species / strain / cell type:
- S. typhimurium, other: TA1535, TA1537, TA97, TA98, TA100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced rat and hamster liver S-9
- Test concentrations with justification for top dose:
- without S-9: 0, 0.3, 1.0, 3.0, 10.0, 16.0 µg/plate (all strains);
with S-9: 0, 10.0, 33.0, 100.0, 333.0, 666.0 µg/plate (TA1535, TA1537 and TA97 + 10% HLI, 10% RLI, 30% HLI or 30% RLI; TA100 and TA98 + 10% HLIor 10% RLI); 0, 3.0, 10.0, 33.0, 100.0, 333.0 µg/plate (TA100 and TA98 + 30% HLI or 30% RLI) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
- Species / strain:
- S. typhimurium, other: TA1535, TA1537, TA97, TA98, TA100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- Precipitation occurred at 666 µg/plate with 10% HLI or 10% RLI in strains TA100, TA1537, TA97, TA98
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
Referenceopen allclose all
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
Chromosome aberrations:
-S9 (harvest time: 10.5 h) |
+S9 (harvest time: 20.0 h, 2nd trial) |
||
Dose (µg/ml) |
% cells with aberrations (total) |
Dose (µg/ml) |
% cells with aberrations (total) |
0 |
3.0 |
0 |
1.5 |
2.99 |
6.0 |
9.95 |
5.0 |
9.95 |
3.0 |
14.9 |
3.5 |
29.9 |
5.0 |
19.9 |
4.0 |
(With metabolic activation, the trial with the higher dose levels was chosen here for presentation)
Maximum number of revertants (mean ± SEM):
Strain |
TA100 |
TA1535 |
TA1537 |
TA97 |
TA98 |
Negative control |
|
|
|
|
|
-S9 |
91 ± 2.8 |
16 ± 3.5 |
8 ± 0.3 |
126 ± 9.5 |
14 ± 2.8 |
+ 10% HLI |
83 ± 4.6 |
10 ± 1.5 |
12 ± 1.9 |
147 ± 9.8 |
23 ± 2.2 |
+ 30% HLI |
166 ± 6.6 |
9 ± 2.3 |
11 ± 1.3 |
187 ± 2.4 |
27 ± 2.2 |
+ 10% RLI |
108 ± 3.2 |
11 ± 2.2 |
7 ± 0.7 |
179 ± 8.9 |
24 ± 3.0 |
+ 30% RLI |
146 ± 4.4 |
16 ± 2.0 |
10 ± 1.2 |
193 ± 5.4 |
20 ± 1.7 |
Test substance |
|
|
|
|
|
-S9 |
90 ± 1.5 (3 µg) |
16 ± 2.3 (1 µg) |
8 ± 1.3 (0.3 µg) |
151 ± 7.4 (3 µg) |
16 ± 2.7 (1 µg) |
+ 10% HLI |
108 ± 5.6 (100 µg) |
9 ± 2.0 (100 µg) |
11 ± 4.0 (10 µg) |
172 ± 16.9 (100 µg) |
31 ± 0.9 (10 µg) |
+ 30% HLI |
150 ± 0.9 (10 µg) |
12 ± 1.5 (10 µg) |
12 ± 0.9 (10 µg) |
201 ± 5.6 (10 µg) |
27 ± 4.1 (33 µg) |
+ 10% RLI |
115 ± 11.6 (10 µg) |
8 ± 1.0 (10 µg) |
10 ± 1.2 (10 µg) |
194 ± 6.4 (10 µg) |
25 ± 0.6 (10 µg) |
+ 30% RLI |
124 ± 11.6 (3 µg) |
15 ± 0.3 (10 µg) |
13 ± 1.0 (10 µg) |
219 ± 8.4 (100 µg) |
25 ± 5.0 (33 µg) |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
The test article was negative in an in vivo dominant lethal assay.
Link to relevant study records
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- 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
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 478 (Genetic Toxicology: Rodent Dominant Lethal Test)
- Principles of method if other than guideline:
- Study performed before actual guideline was established.
- GLP compliance:
- not specified
- Type of assay:
- rodent dominant lethal assay
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Flow
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 30 ± 2.5 g
- Housing: 5/cage while treated, then after 2 days rest separately with two females for mating
- Diet (e.g. ad libitum): 4 % fat diet ad libitum
- Water (e.g. ad libitum): acidified according to approved laboratory animal health standards, ad libitum - Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Duration of treatment / exposure:
- 5 days
- Frequency of treatment:
- daily
- Post exposure period:
- 2 days
- Dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 166 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 500 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 10 males
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- triethylenemelamine
- Route of administration: intraperitoneal
- Doses / concentrations: 0.3 mg/kg bw in 0.85 % saline - Tissues and cell types examined:
- number of dead, living, and total embryos in the uterus
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
1/10, 1/30 and 1/100 of LD50; but high dose of 500 mg/kg bw was selected by the contract monitor, other doses were then calculated in relation to this dose.
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):
Males were treated for 5 consecutive days, after 2 days rest each male was mated with 2 virgin females from Monday through Friday. This sequence was repeated weekly with 2 new females each week for 8 weeks (period of spermatogenesis). Fourteen days from the midweek in which they were caged with the males (mid-pregnancy), females were sacrificed, dissected, and the number of dead, living, and total embryos in the uterus as well as the level of fertility recorded. - Evaluation criteria:
- Dominant lethality is indicated by a high percentage of dead implants to total implants.
- Statistics:
- The number of dead, living, and total embryos in the uteri were statistically analyzed for indications of dominant lethality, and compared with control data for significance.
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
Reference
Dominant lethality was not demonstrated by data from PANA administered to mice. In comparison, the positive control compound TEM demonstrated a clear dominant lethal effect in mice during weeks 1 through 3.
Dead implants / total implants:
Week |
Negative control |
50 mg/kg |
166 mg/kg |
500 mg/kg |
Positive control |
1 |
0/72 = 0.0 |
1/45 = 0.02 |
1/64 = 0.02 |
0/34 = 0.0 |
7/16 = 0.44* |
2 |
3/118 = 0.03 |
3/126 = 0.02 |
5/77 = 0.06 |
5/135 = 0.04 |
39/50 = 0.78** |
3 |
7/117 = 0.06 |
1/75 = 0.01 |
0/84 = 0.0 |
5/97 = 0.05 |
20/46 = 0.43** |
4 |
4/138 = 0.03 |
5/81 = 0.05 |
5/61 = 0.08 |
1/106 = 0.01 |
8/160 = 0.05 |
5 |
4/50 = 0.07 |
5/106 = 0.06 |
1/44 = 0.02 |
3/60 = 0.05 |
0/12 = 0.0 |
6 |
4/204 = 0.02 |
3/143 = 0.02 |
9/148 = 0.06* |
4/142 = 0.03 |
7/183 = 0.04 |
7 |
5/139 = 0.04 |
1/28 = 0.04 |
6/112 = 0.05 |
7/116 = 0.06 |
4/117 = 0.03 |
8 |
7/135 = 0.05 |
8/125 = 0.06 |
4/74 = 0.05 |
2/68 = 0.03 |
1/132 = 0.01 |
* P<0.05
**P<0.01
Isolated instances of apparent significant dominant lethality did occur among the experimental data. They were not associated with dose-related trends and had dead implant/total input ratios that fell within the range of all negative controls (intermediate dose, week 6).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
In vitro data
N-phenyl-1-naphthylamine was not mutagenic in bacterial tests conducted in the presence or absence of metabolic activation. These tests included bacterial Salmonella typhimurium (Zeiger et al., 1988; Rannug et al., 1984) or Salmonella typhimurium/E.coli WP2 (Baden et al., 1978; Brusick and Matheson, 1976, 1977) reverse mutation assays. A mitotic recombination assay in Saccharomyces cerevisiae yielded also negative results (Brusick and Matheson, 1976, 1977). In mammalian cells, no mutagenicity was observed in the mouse lymphoma (L5178Y cells) assay with and without metabolic activation (Brusick and Matheson, 1976, 1977). In the presence and absence of an external metabolising system, N-phenyl-1-naphthylamine did not lead to an increase in chromosomal aberrations in Chinese hamster ovary cells or in Chinese hamster lung fibroblasts (Loveday et al., 1990; Sofuni et al., 1990).
A sister chromatid exchange (SCE) assay in Chinese hamster ovary cells was marginally positive in the presence of an external metabolising system, but not without metabolic activation (Loveday et al., 1990). An unscheduled DNA synthesis (UDS) assay with human lung (WI-38) cells yielded ambiguous results (Brusick and Matheson, 1976, 1977). Repeatedly positive responses occurred in non-activated but not in activated (negative in the 1st trial, positive in the 2nd trial) test systems and the effects showed no dose-response relationship. The findings of the UDS assay were contradictory to the negative results in the chromosomal aberration assays as well as to the weakly positive result the SCE assay which was only positive in presence of an external metabolising system. With respect to the conflicting results and the lack of dose-response relationship, these findings should be considered as artefacts and not taken into account for assessment.
In vivo data
A dominant lethal assay conducted in mice did not produce significant adverse effects on reproductive performance parameters (Brusick and Matheson, 1976, 1977). Male mice were intraperitoneally administered N-phenyl-1 -naphthylamine for 5 consecutive days followed by 2 days without exposure. Each male was then caged with two virgin females. The examination of the females showed no alterations in the number of dead embryos in the uteri compared to the control animals.
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. The in vitro
and in vivo studies are negative for genetic toxicity. As a result the
substance is not considered to be classified for genetic toxicity under
Regulation (EC) No 1272/2008, as amended for the eighth time in
Regulation (EU) No 2016/218.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.