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EC number: 202-426-4 | CAS number: 95-51-2
- 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 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:
- 1988-10-04 to 1988-10-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 2-chloroaniline
- EC Number:
- 202-426-4
- EC Name:
- 2-chloroaniline
- Cas Number:
- 95-51-2
- Molecular formula:
- C6H6ClN
- IUPAC Name:
- 2-chloroaniline
- Details on test material:
- - Name of test material (as cited in study report): o-chloroaniline
- Physical state: yellow to orange liquid
- Analytical purity: 99.6 % (analytical results dated 1988-02-01, see 7.2.3, key, 1, Bomhard, 1988, IUC4 )
- Purity test date: 1988-02-01
- Lot/batch No.: Lagerkessel 15/ 594 488
- Stability under test conditions: stable throughout the test period
- Storage condition of test material: 3-7°C, dark
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 29 to 45 g
- Assigned to test groups randomly:yes
- Fasting period before study: no data
- Housing: 3 to 5 mice per macrolon cage I or II, respectively, bedding: wood chips S8/15 (Ssniff)
- Diet: ad libitum, Altromin 1324
- Water: ad libitum, tap water
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22*-2
- Humidity (%): ~50 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: polyethylene glycol (Luterol E400)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
oral gavage - Duration of treatment / exposure:
- single
- Frequency of treatment:
- single
- Post exposure period:
- 48 h (cyclophosphamid 24h)
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
500 mg/kg body weight
Basis:
- Remarks:
- Doses / Concentrations:
1000 mg/kg body weight
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
1500 mg/kg body weight
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5 per sex per dose or control (total 50 mice + 10 exposed mice (1500 mg/kg) in the replacement group)
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Route of administration: oral gavage
- Doses / concentrations: 20 mg/kg body weight (10 mL/kg)
Examinations
- Tissues and cell types examined:
- bone marrow (femur)
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Pilot test for maximal tolerable dose finding with groups of 5 animals, that were orally administered 800 or 1000 mg o-chloroaniline/kg body weight. one animal of the high dose group died. Up to 72 h post-dose apathy, roughend fur, pallor, prone position,
twitching, shivering and difficult breathing were observed
TREATMENT AND SAMPLING TIMES : Animals received vehicle or 500, 1000 or 1500 mg o-chloroaniline/kg body weight single per orale gavage (5 mL/ kg body weight), 10 positive control animals were sacrificed by decaptation after 24 h, the other treated animals were decaptated after 48 h (10 each), 11 of 20 treated animals (high-dose) died during the test
DETAILS OF SLIDE PREPARATION: According to Schmid's method (1975), briefly, femurs were prepared, bone marrow was immersed in calf serum and flushed serveral times from both ends of the femur, the resulting cell suspension was centrifuged 5 min at 1000 rpm, the supernatant was almost totally discarded and the pellet resuspended. one drop was added to a slide, spread, dried over night, stained and covered
METHOD OF ANALYSIS: light microscope (magnification 1000x) The micronuclei apear as stained chromatin in the anucleated erythrocytes. 1000 polychromatic erythrocytes were counted per animal. Ratio of poly- to normochromatic erythrocytes was determined and normochromatic erythrocytes with micronuclei counted as well. - Evaluation criteria:
- see above
- Statistics:
- Wilcoxon's non-parametric rank sum test (p< 0.01)
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- positive
- Remarks:
- weak significant clastogenic effect after 48 h in high-dose group
- Toxicity:
- yes
- Remarks:
- appathy, roughened fur, pallor, prone position, spasm, twitching, shivering, eyelid closure, rapid breathing, ratio between poly- and normochromatic erythrocytes unchanged
- Vehicle controls validity:
- valid
- Negative controls validity:
- other: historical
- Positive controls validity:
- valid
Any other information on results incl. tables
treated animals showed lasting symptoms of toxicity (11/20
animals died at a dose of 1500 mg/kg), the ratio
polychromatic/normochromatic erythrocytes was not altered,
at doses at or above 1000 mg/kg an increased incidence of
micronuclei-bearing polychromatic erythrocytes was observed, thus indicating a weak clastogenic effect.
negative control 48 h
sex |
polychromatic erythrocytes |
no. normochromatic erythrocytes per 1000 polychromatic erythrocytes |
micronucleated cells per 1000 normochromatic erythrocytes |
micronucleated cells per 1000 polychromatic erythrocytes |
m | 1000 | 751 | 1.3 | 3 |
m | 1000 | 584 | 0 | 2 |
m | 1000 | 889 | 1.1 | 0 |
m | 1000 | 689 | 0 | 4 |
m | 1000 | 1362 | 1.5 | 1 |
f | 1000 | 991 | 3.0 | 2 |
f | 1000 | 801 | 2.5 | 1 |
f | 1000 | 717 | 0 | 3 |
f | 1000 | 1291 | 0.8 | 1 |
f | 1000 | 995 | 0 | 0 |
mean/SD | 1000 | 907/257 | 1.0/1.1 | 1.7/1.3 |
positive control 20 mg/kg cyclophosphamide per oral 24h
sex |
polychromatic erythrocytes |
no. normochromatic erythrocytes per 1000 polychromatic erythrocytes |
micronucleated cells per 1000 normochromatic erythrocytes |
micronucleated cells per 1000 polychromatic erythrocytes |
m | 1000 | 1552 | 1.3 | 23 |
m | 1000 | 1298 | 0.8 | 13 |
m | 1000 | 1241 | 0 | 23 |
m | 1000 | 994 | 1.1 | 24 |
m | 1000 | 822 | 1.2 | 18 |
f | 1000 | 827 | 0 | 6 |
f | 1000 | 953 | 1.0 | 9 |
f | 1000 | 753 | 0 | 9 |
f | 1000 | 465 | 0 | 9 |
f | 1000 | 750 | 0 | 9 |
mean/SD | 1000 | 961/318 | 0.5/0.6 | 14.3/7. |
test substance o-chloroaniline 500 mg/kg 48 h
sex | polychromaticerythrocytes | no. normochromatic erythrocytes per 1000 polychromatic erythrocytes | micronucleated cells per 1000 normochromatic erythrocytes | micronucleated cells per 1000 polychromatic erythrocytes |
m | 1000 | 892 | 1.1 | 2 |
m | 1000 | 1373 | 2.9 | 0 |
m | 1000 | 861 | 2.3 | 2 |
m | 1000 | 1262 | 0.8 | 1 |
m | 1000 | 826 | 1.2 | 0 |
f | 1000 | 590 | 1.7 | 3 |
f | 1000 | 565 | 0 | 0 |
f | 1000 | 656 | 3.0 | 0 |
f | 1000 | 451 | 0 | 4 |
f | 1000 | 735 | 0 | 3 |
mean/SD | 1000 | 821/297 | 1.3/ 1.2 | 1.5/ 1.5 |
test substance o-chloroaniline 1000 mg/kg 48 h
sex | polychromatic erythrocytes | no. normochromatic erythrocytes per 1000 polychromatic erythrocytes | micronucleated cells per 1000 normochromatic erythrocytes | micronucleated cells per 1000 polychromatic erythrocytes |
m | 1000 | 981 | 1.0 | 3 |
m | 1000 | 1169 | 0.9 | 2 |
m | 1000 | 1130 | 2.7 | 5 |
m | 1000 | 900 | 1.1 | 3 |
m | 1000 | 863 | 0 | 2 |
f | 1000 | 703 | 0 | 3 |
f | 1000 | 1112 | 1.8 | 3 |
f | 1000 | 1119 | 0 | 5 |
f | 1000 | 688 | 0 | 9 |
f | 1000 | 1494 | 1.3 | 6 |
mean/SD | 1000 | 1016/242 | 0.9/ 0.9 | 4.1/ 2.2 |
test substance o-chloroaniline 1500 mg/kg 48 h
sex | polychromaticerythrocytes | no. normochromatic erythrocytes per 1000 polychromatic erythrocytes | micronucleated cells per 1000 normochromatic erythrocytes | micronucleated cells per 1000 polychromatic erythrocytes |
m | 1000 | 1875 | 1.6 | 2 |
m | 1000 | 892 | 0 | 2 |
m | 1000 | 1017 | 1.0 | 7 |
m | 1000 | 1116 | 0 | 8 |
m | male died without replacement | |||
f | 1000 | 2265 | 0.9 | 6 |
f | 1000 | 491 | 0 | 2 |
f | 1000 | 1280 | 0 | 4 |
f | 1000 | 1120 | 0 | 8 |
f | 1000 | 578 | 0 | 7 |
mean/SD | 1000 | 1182/573 | 0.4/ 0.6 | 5.1*/ 2.6 |
* p< 0.01 in non-prametric Wilcoxon ranking test
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): positive weakly clastogenic
There were biologically important and statistically significant variations in regard to incidence of micronucleated polychromatic erythrocytes between the negative control and the group orally treated with 1500 mg/kg body weight. - Executive summary:
Herbold, BA (1989)
o-chloroaniline was orally administed (gavage) to NMRI mice at a concentration of 500, 1000 or 1500 mg/kg body weight in polyethylene glycol and the clastogenic effect on polychromatic erythrocytes of the bone marrow (femur) was estimated after 48 h according to EU method B.12 utilizing the method introduced by Schmid (1975). Cyclophosphamide (20 mg/kg per os) served as positive control. A significant increase in micronuclei formation, 5.1/1000 (+/- 2.6), was observed 48 h post-application in bone marrow of mice treated with o-chloroaniline (1500 mg/kg). The positive and vehicle controls were valid, 14.3/1000 (+/- 7.0) and 1.7/1000 (+/- 1.3). Therefore indications of a weak clastogenic effect of o-chloroaniline at high doses were found.
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