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EC number: 205-182-7 | CAS number: 135-19-3
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- no
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- 2-naphthol
- EC Number:
- 205-182-7
- EC Name:
- 2-naphthol
- Cas Number:
- 135-19-3
- Molecular formula:
- C10H8O
- IUPAC Name:
- 2-naphthol
- Test material form:
- solid: flakes
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Japan SLC, Inc.
- Age at study initiation: 9 weeks of age
- Weight at study initiation: 24.5 to 27.7 g
- Assigned to test groups randomly: yes
- Housing: housed in a zyfone animal cage
- Diet: pellet diet (MF: Oriental Yeast Co., Ltd.; Lot No. 040310) ad libitum
- Water: tap water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.4 to 24.3°C
- Humidity (%): 54 to 67%
- Air changes (per hr): 18 times per hour
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: CMC
- Amount of vehicle: 0.1 mL per 10 g body weight
- Lot/batch no.: . PKG2104 - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The test substance was suspended in 0.5 w/v% methylcellulose solution using mortar and pestle.
- Duration of treatment / exposure:
- Two days
- Frequency of treatment:
- Once a day
- Post exposure period:
- 24 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 62.5 mg/kg bw/day
- Dose / conc.:
- 125 mg/kg bw/day
- Dose / conc.:
- 250 mg/kg bw/day
- No. of animals per sex per dose:
- 5 animals / dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - Positive control: Mitomycin C
- Justification for choice of positive control(s): OECD TG 474
- Route of administration: intraperitoneal
- Doses / concentrations: 0.5 mg/kg
Examinations
- Tissues and cell types examined:
- Bone marrow erythrocytes
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
On the basis of the results of a dose-finding study, 250 mg/kg, which is near the dose inducing toxic signs, was selected as the highest dose, and three doses including 125 and 62.5 mg/kg (common ratio of 2) were selected. Since there was no evident sex difference in the incidences of toxic signs, only male mice were used for this study.
TREATMENT AND SAMPLING TIMES:
Mice were euthanized by inhalation of carbon dioxide at 24 hours after the final dosing (at 24 hours after dosing in case of the positive control).
DETAILS OF SLIDE PREPARATION:
Femur was removed, and the bone marrow cells were flushed out with small amount of calf serum (Invitrogen Corp.; Lot No. 1172087, inactivated at 56°C for 30 minutes) into a centrifuge tube. Excess serum was removed by centrifugation method and the bone marrow cells were smeared on 3 slides per animal. The smears were dried well and were then fixed using methanol. Two smears per animal were stained with 3% Giemsa solution (Merck KGaA; Lot No. OB279210) for 30 minutes. They were rinsed with 1/100 mol/L sodium phosphate buffer (Merck KGaA; pH 6.8; Lot No. TP601374) and purified water, and dried. Then, these slides were rinsed with 0.01% citric acid solution and purified water, and dried again.
The bone marrow smear slides were prepared from all animals.
METHOD OF ANALYSIS:
All samples were coded and then examined by the blind method. Two thousand polychromatic erythrocytes (PCE) per animal were analyzed using a microscope (×1000). The number of micronucleated polychromatic erythrocytes (MNPCE) was counted. To examine the effect of test substance on bone marrow cells, the number of PCE out of a total of 500 erythrocytes was also counted. - Evaluation criteria:
- The results were evaluated to be positive when the statistically significant difference was detected in the each treatment group or in the positive control group as compared to the negative control group.
- Statistics:
- The Conditional Binomial test (Kastenbaum and Bowman method: upper-tailed significance level of 0.025) was performed to compare the frequency of MNPCE in the negative control group with that in each treatment group and positive control group.
The ratios of polychromatic erythrocytes to total erythrocytes were subjected to Dunnett’s multiple comparison test (two-tailed significance level of 0.05) for the analysis of significant differences between the negative control group and the groups treated with the test substance. The data obtained from the negative and positive control groups were subjected to Aspin-Welch t test (two-tailed significance level of 0.05).
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 62.5 to 1,000 mg/kg bw
- Clinical signs of toxicity in test animals: Mortality observed at 500 and 1,000 mg/kg bw in both male and female animals. Reduction of body weight was observed in both sexes at 250 mg/kg bw, as well as decreased locomotor activity and/or hypothermia.
- Rationale for exposure: Based on available information on the toxicity of the substance at the time of the study.
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei: The frequencies of MNPCE in the groups treated with the 2-Naphthol were 0.27, 0.22 and 0.29% in 62.5, 125 and 250 mg/kg groups, respectively.
Any other information on results incl. tables
Micronucleus assay
In the negative control group, 2 to 6 micronucleated cells (MNPCE) in 2000 polychromatic erythrocytes (PCE) per animal were noted indicating an incidence of 0.18%. The ratio of PCE to the total number of erythrocytes was 57.6%.
The frequencies of MNPCE in the groups treated with the 2-Naphthol were 0.27, 0.22 and 0.29% in 62.5, 125 and 250 mg/kg groups, respectively. No statistically significant increase was noted in any of the treatment groups as compared to the negative control group. The ratios of PCE to the analyzed erythrocytes, an index of the effects of the test substance on the bone marrow cells, were 54.6, 54.8 and 48.7% in 62.5, 125 and 250 mg/kg groups, respectively. No significant decrease was noted in any of the treatment groups as compared with that in the negative control group.
On the other hand, the incidence of MNPCE in the positive control group was markedly increased to 1.18% (15 to 32 MNPCEs in 2000 PCEs), and a statistically significant increase (p=0.025) was found as compared with the negative control group. The ratio of PCE was 54.0%.
Body weight and clinical observations
Due to the treatment with 2-Naphthol, 1 out of 8 males died at 21 hours after the first dosing of 250 mg/kg. In addition, toxic signs such as decrease in locomotor activity and so on were observed in the animals receiving 250 mg/kg from 1 hour after the first dosing, and 3 g reduction of mean body weight value was observed.
Applicant's summary and conclusion
- Conclusions:
- 2-Naphthol did not induce micronucleated erythrocytes in mouse bone marrow cells, i.e. structural nor numerical chromosome aberrations, under the conditions employed in this study.
- Executive summary:
To assess the potential of 2-Naphthol for inducing micronucleated erythrocytes, an in vivo micronucleus test was conducted on male mice using a method similar to the OECD Testing Guideline 474. The study was not GLP-compliant.
On the basis of the results of dose-finding study, 250 mg/kg, which is near the dose inducing toxic signs, was selected as high dose, and three doses including 125 and 62.5 mg/kg were selected. Since there was no evident sex difference in the incidences of toxic signs, only male mice were used for the present micronucleus assay.
The results revealed that the frequency of MNPCE in any of the 2-Naphthol-treated groups was comparable to that in the negative control group and no statistically significant increase was found. No statistically significant decrease in the ratio of PCE to the analyzed erythrocytes was observed in any of the test substance-treated groups.
It was concluded that 2-Naphthol did not induce micronucleated erythrocytes in mouse bone marrow cells, i.e. structural nor numerical chromosome aberrations, under the conditions employed in this study.
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