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EC number: 240-886-8 | CAS number: 16867-03-1
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30.08. - 07.12.2004
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian germ cell cytogenetic assay
Test material
- Reference substance name:
- 2-aminopyridin-3-ol
- EC Number:
- 240-886-8
- EC Name:
- 2-aminopyridin-3-ol
- Cas Number:
- 16867-03-1
- Molecular formula:
- C5H6N2O
- IUPAC Name:
- 2-aminopyridin-3-ol
1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Number of animals: 81 (45 males/36 females)
Initial age at start of acclimatization: Males: 5 - 8 weeks, females: 7 - 10 weeks
Acclimatisation: minimum 5 days
Initial Body Weight at Start of Treatment: males mean value 35.4 g (SD ± 2.4 g), females mean value 31.7 g (SD ± 2.8 g)
Housing: single
Bedding: Granulated soft wood bedding
Feed: Pelleted standard diet, ad libitum
Water: Tap water, ad libitum
Environment: Temperature 22 ± 3 °C, relative humidity 30 - 83 %, artificial light 6.00 a.m. - 6.00 p.m.
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- CMC
- Details on exposure:
- The test item was formulated in 2.5% CMC. The vehicle was chosen to its relative non-toxicity for the animals. All animals received a single standard volume of 10 mL/kg body weight intraperitoneally.
- Duration of treatment / exposure:
- single administration
- Frequency of treatment:
- single administration
- Post exposure period:
- 24 and 48 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 12.5 mg/kg bw/day (nominal)
- Remarks:
- 24 h preparation interval
- Dose / conc.:
- 25 mg/kg bw/day (nominal)
- Remarks:
- 24 h preparation interval
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Remarks:
- 24 h preparation interval
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Remarks:
- 48 h preparation interval
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Substance: Cyclophosphamide (CPA)
Dissolved in: deionised water
Dosing: 40 mg/kg bw
Route and frequency of administration: i.p., once
Volume adminstered: 10 ml/ kg bw
Solution prepared on day of administration.
Examinations
- Tissues and cell types examined:
- Blood cells - erythrocytes
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- other: vehicle served as negative control
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- In conclusion, it can be stated that under the experimental conditions reported, the test item did not induce micronuclei as determined by the micronucleus test with bone marrow cells of the mouse.
Therefore, A 132 is considered to be non-mutagenic in this micronucleus assay. - Executive summary:
This study was performed to investigate the potential of A 132 to induce micronuclei in polychromatic erythrocytes (PCE) in the bone marrow of the mouse.
The test item was formulated in 2.5% CMC, which was also used as vehicle control. The volume administered intraperitoneally (i.p.) was 10 mL/kg b.w.. 24 h and 48 h after a single administration of the test item the bone marrow cells
were collected for micronuclei analysis.
Ten animals (5 males, 5 females) per test group were evaluated for the occurrence of micronuclei. At least 2000 polychromatic erythrocytes (PCEs) per animal were scored for micronuclei.
To describe a cytotoxic effect due to the treatment with the test item the ratio between polychromatic and total erythrocytes
was determined in the same sample and reported as the number of PCEs per 2000 erythrocytes.
The following dose levels of the test item were investigated:
24 h preparation interval: 12.5, 25 and 50 mg/kg b.w..
48 h preparation interval: 50 mg/kg b.w..
As estimated by pre-experiments 50 mg A 132 per kg b.w. was the highest applicable dose without significant effects on the survival rates, but with clear signs of toxicity. At a higher dose (75 mg/kg) all 4 treated animals died.
After treatment with the test item the number of PCEs was not substantially decreased as compared to the mean value of PCEs of the vehicle control thus indicating that A 132 did not exert any cytotoxic effects in the bone marrow. The bioavailability of the test item was, however, confirmed by chemical analysis of the blood of the treated animals.
In comparison to the corresponding vehicle controls there was no biologically relevant or statistically significant enhancement in the frequency of the detected micronuclei at any preparation interval after administration of the test item and with any dose level used.
40 mg/kg b.w. cyclophosphamide administered i.p. was used as positive control which showed a substantial increase of induced micronucleus frequency.
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