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EC number: 217-682-2 | CAS number: 1929-82-4
- 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
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 December 1984 to 11 March 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A GLP study conducted to sound scientific principles with a sufficient level of detail to assess the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Nitrapyrin
- EC Number:
- 217-682-2
- EC Name:
- Nitrapyrin
- Cas Number:
- 1929-82-4
- Molecular formula:
- C6H3Cl4N
- IUPAC Name:
- 2-chloro-6-(trichloromethyl)pyridine
- Test material form:
- solid: crystalline
- Details on test material:
- - Appearance: white crystalline solid
- Storage conditions of test material: in the dark at room temperature
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 24 - 31 g (males); 22 - 30 g (females)
- Housing: housed in groups of 5 animals of the same sex in polypropylene cages with solid floors and wire mesh lids
- Assigned to test groups randomly: yes (randomised to groups of 5 with approximately equal group weights)
- Diet: ad libitum
- Water: tap water, ad libitum
- Acclimation period: short period (not specified)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 23 °C
- Humidity (%): 50 ± 5 %
- Air changes (per hr): at least 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of darkness / 12 hours of light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Test material was dissolved in corn oil by stirring at room temperature.
For the initial range-finder solutions of 20, 30 and 40 mg/mL were prepared; for the detailed range-finder test solutions of 16, 24, 32 and 40 mg/mL were prepared, and for the main micronucleus assay a solution of 32 mg/mL was prepared. In all cases the dose volume was 25 mL/kg - Duration of treatment / exposure:
- Animals were treated by oral gavage
- Frequency of treatment:
- Single administration
- Post exposure period:
- Groups were killed 24, 48 and 72 hours following treatment.
Doses / concentrations
- Dose / conc.:
- 800 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 15 males and 15 females per dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide
- Route of administration: Oral gavage
- Doses / concentrations: 80 mg/kg (3.2 mg/mL and a dose volume of 25 mL/kg)
Examinations
- Tissues and cell types examined:
- One femur from each animal was exposed, removed, cleaned of adherent muscle and connective tissue so that the shank could be removed from the ends by using fine clippers or scissors. Disposable centrifuge tubes containing 1 mL of foetal bovine serum (FBS) were labelled with the animal numbers.
Approximately 0.5 mL of FBS was drawn into a 1 mL syringe with a fresh needle, and this was used to aspirate the contents of the femur into the centrifuge tube. - Details of tissue and slide preparation:
- The disposable centrifuge tubes containing the contents of the femurs were centrifuged at 2000 rpm for 2 - 3 minutes, the serum was carefully decanted to leave one or two drops of serum and the cell pellet. The pellet was mixed into this small volume of serum in each tube by using a Pasteur pipette, and from each tube one drop of suspension was placed on the end of 4 labelled slides. The end of a clean slide was placed across the drop, and a smear made by drawing the clean slide along the labelled slide.
Slides were allowed to air-dry and were stored for at least 48 hours before staining. In brief, two slides from each set of four were taken (the others were kept in reserve but, on this occasion were not needed) and fixed for 5 minutes in absolute ethanol. After rinsing several times in water, the slides were then stained for 10 minutes in Gurr's Giemsa R66 stain diluted 1:6 (v/v) in distilled water. Slides were rinsed, and allowed to dry thoroughly before clearing in xylene for 3 minutes. When dry, slides were finally mounted with coverslips. - Statistics:
- The numbers of micronucleated PCE and NCE of groups treated with test material or positive control were compared to vehicle controls using the chi-squared method.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Mice treated with test material exhibited PCE/NCE ratios which were similar to vehicle controls at 24 hours. There was some indication of toxicity as the ratios tended to be lower than controls at 48 and, in particular, at 72 hours where the control PCE/NCE range was 0.42 - 0.82, but six test material-treated mice had ratios in the range 0.09 - 0.51. The numbers of micronucleated PCE and NCE were generally similar to those seen in controls. Group mean frequencies exceeded controls for micronucleated PCE at 72 hours and micronucleated NCE at 48 hours, but the differences were small and not significant by chi-squared analysis. In all other cases the mean frequencies of micronucleated PCE and NCE were lower than in controls, and for micronucleated NCE at 24 and 72 hours these decreases were significant by chi-squared analysis.
All vehicle control mice exhibited a normal PCE/NCE ratio in the region of 1.0 (0.4 - 2.4 was the range).
Mice treated with the positive control chemical exhibited much lower PCE/NCE ratios (0.12 - 0.38) indicating some bone marrow toxicity. In 7 out of the 10 CPA-treated mice, numbers of micronucleated PCE clearly exceeded those seen in vehicle controls, such that the mean frequency (27.3/1000) was 5x the highest mean frequency seen in controls. Chi-squared analysis on the total counts revealed the increased numbers of micronuclei to be significant. In addition, in at least 8 of the 10 CPA-treated mice, numbers of micronucleated NCE also clearly exceeded those seen in vehicle controls, such that total numbers of micronucleated NCE in the CPA group were significantly different from controls by chi-squared analysis.
Any other information on results incl. tables
Table 1: Summary of group mean data for test material, vehicle and positive control
Treatment group |
Kill time (hours) |
Sex |
Mean ratio (PCE/NCE) |
Mean frequency of micronucleated PCE (/1000) |
Mean frequency of micronucleated NCE (/1000) |
||
per sex |
per group |
per sex |
per group |
||||
Vehicle control |
24 |
M |
1.30 |
5.20 |
5.69 |
6.17 |
7.70 |
F |
1.54 |
6.19 |
9.24 |
||||
48 |
M |
0.85 |
4.80 |
4.50 |
4.01 |
3.79 |
|
F |
0.71 |
4.20 |
3.57 |
||||
72 |
M |
0.64 |
1.80 |
2.30 |
2.62 |
2.73 |
|
F |
0.64 |
2.80 |
2.84 |
||||
Test material |
24 |
M |
1.47 |
5.20 |
4.50 |
6.36 |
5.50 |
F |
0.94 |
3.80 |
4.65 |
||||
48 |
M |
0.64 |
3.60 |
4.00 |
5.20 |
4.61 |
|
F |
0.68 |
4.40 |
4.03 |
||||
72 |
M |
0.43 |
2.00 |
2.40 |
2.18 |
1.81 |
|
F |
0.55 |
2.80 |
1.43 |
||||
Positive control |
48 |
M |
0.17 |
13.2 |
27.30 |
9.61 |
13.09 |
F |
0.28 |
41.4 |
16.56 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: Negative
Under the conditions of the study, the test material was not able to induce micronuclei in the polychromatic or normochromatic erythrocytes of the bone marrow of mice treated with the maximum tolerated dose of 800 mg/kg. - Executive summary:
The clastogenic potential of the test material was investigated in a study which was conducted under GLP conditions and following a method similar to that which is outlined in the standardised guideline OECD 474.
During the study, the test material was evaluated for its ability to induce micronuclei in mice. A maximum tolerated dose of 800 mg/kg was established and this was administered to three groups of mice (5 male and 5 females per group). Test material was administered in corn oil by oral gavage; corn oil alone was administered to control mice.
The three groups of mice were killed after 24, 48 and 72 hours, and slides prepared from bone marrow.
Some evidence of bone marrow toxicity was obtained, evidenced by a slight decrease in the ratio of polychromatic to normochromatic erythrocytes (PCE/NCE). The test material did not produce an increase in micronuclei in either PCE or NCE. It is therefore concluded that the test material is not clastogenic in the micronucleus test.
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