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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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 1989-01-10 to 1989-02-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.8 (Subacute Inhalation Toxicity: 28-Day Study)
- Version / remarks:
- Cited as Directive 84/449/EEC, B.8
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
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-Chloraniline
- Physical state: yellow-orange, clear liquid
- Analytical purity: 99.6 % (IR spectroscopy)
- Impurities (identity and concentrations):
<0.01 % cyclohexylamine
<0.01 % N-isopropylaniline
<0.01 % 2-chloro-N-Isopropylanilin
0.08% aniline
<0.01% 2-Isopropylaniline
<0.01% o-nitrochlorobenzene
0.24% p-chloroaniline
<0.01% m-chloroaniline
<0.01% 2,4-dichloroaniline
<0.01% 2,5-dichloroaniline
<0.01% 2,3-dichloroaniline
<0.01% 2,3-dichloroaniline
<0.01% o-phenylendiamine
0.03 % unknown impurities
- Purity test date: 1 Feb 1988
- 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:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: 2-3 months
- Weight at study initiation: 165-206 g
- Fasting period before study:
- Housing: 5 (randomized) per macrolon III cage, changed every week, animals marked individually,
- Bedding: wood chips Type S8/15 Ssniff
- Diet: ad libitum; Altromin 1324
- Water: ad libitum; tap water
- Acclimation period: ~14 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12, artificial 14 W/m²
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- other: unchanged (no vehicle)
- Remarks on MMAD:
- MMAD / GSD: not applicable, vapour was tested
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: from Rhema Labortechnik, Hofheim, Germany
- Exposure chamber volume: 7 L
- Method of holding animals in test chamber: animals were held in place in special test tubes
- Source and rate of air: 10 L/ min; about 85 air changes /h
- Method of conditioning air: air was led through a bottle with prewarmed test substance
- Method of particle size determination: aerodynamic particle sizer with laser-velocimeter (TSI-APS 3300)
- Treatment of exhaust air: 70 % of the incoming air were withdrawn as exhaust air
- Temperature, humidity, pressure in air chamber:
vapour: T= ~23°C
Humidity= ~30 %
TEST ATMOSPHERE (vapour)
- Brief description of analytical method used: Ratfisch RS 55 gas chromatograph with flame ionisation detector
- Samples taken from breathing zone: yes, at the beginning, in the middle and towards the end of each test, 0.5 L/min 10-18 L per test sample - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The analytical verifiction of the applied dose was realised with a gas chromatograph equipped with a flame ionisation detector
- Duration of treatment / exposure:
- 4 w
- Frequency of treatment:
- 6 h/d, 5 d/w
Doses / concentrations
- Remarks:
- Doses / Concentrations:
39, 217 and 886 mg/m³ (7, 41 and 169 ppm)
Basis:
analytical conc.
- No. of animals per sex per dose:
- 10 per sex and dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Post-exposure period: none
- Positive control:
- none
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes / No / No data
- Time schedule: twice a day (also on weekends)
DETAILED CLINICAL OBSERVATIONS: Yes, observed were changes in the skin and fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behaviour pattern, not adequately
performable inside the test tube
BODY WEIGHT: Yes
- Time schedule for examinations: application day 1, 8, 15, 22 and day 29
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION: No data
OPHTHALMOSCOPIC EXAMINATION: Yes, retina, vitreous, lens, cornea, conjunctivae, eyelids
- Time schedule for examinations: day 0 and week 4
- Dose groups that were examined: 5 animals per dose and sex
HAEMATOLOGY: Yes
- Time schedule for collection of blood: after 4th exposure day and week 2
- Anaesthetic used for blood collection: No
- Animals fasted: general no ( for glucose measurement in week 3; yes)
- How many animals: 5 per dose per sex
- Parameters checked: leucocyte count, hematocrit, hemoglobin, erythrocyte count, MCV, MCHC, MCH, reticolocyte count, thrombocyte count, Heinz bodies, methemoglobin, clotting potential
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at time of dissection (after 4 week study), heart puncture ( bleeding to death),
- Anaesthetic used for blood collection: Yes, diethyl ether
- Animals fasted: No data
- How many animals: 40
- Parameters checked:
enzymes: GOT, GPT, AP, GLDH, LDH, ChE, CK,
substrates: glucose, Urea, bilirubin, creatinin, total protein, albumin, triglycerides, cholesterol,
protein electrophorese: globulines, albumin
electrolytes: Na, K, Mg, Ca, anorganic P, Cl
URINALYSIS: Yes / No / No data
- Time schedule for collection of urine: over night for 17 h in week 3
- Metabolism cages used for collection of urine: Yes , animals received 5 mL of water by oral gavage prior to sampling
- Animals fasted: Yes
- Parameters checked:
quantitative: volume, weight, pH, protein
semiquantitative: protein, blood, glucose, bilirubin, urobilinogen, ketone bodies
sediment: leucocytes, erythrocytes, epithelial cells, bacteria, amorphous salts, tripel phosphate, calcium oxalate
NEUROBEHAVIOURAL EXAMINATION: Yes / No / No data
- Time schedule for examinations: day 14 and 25 after exposure
- Dose groups that were examined: all
- Battery of functions tested: sensory activity / grip strength / motor activity - Sacrifice and pathology:
- HISTOPATHOLOGY: Yes: aorta, eye, eyelid, gut, extraorbital lacrimal, femur, brain, harder gland, skin, heart, testicles, epididymides, urinary bladder, hypophsis, bone marrow, coagulation gland, head, larynx, liver, lymph knots, stomach, mamma, spleen, muscle, adrenal, nervus ichiadicus, kidneys, esophagus, ovaries, pancreas, pharynx, prostata, medulla, seminal vesicle, thyroid, parathyroid, salivary gland, sternum, thymus, trachea, uterus, tongue
- Other examinations:
- relative (per 100 body weight) and absolut organ weight: brain, heart, testicles, liver, lung, spleen, adrenal, kidneys, ovaries, thymus, thyroid,
- Statistics:
- randomized with IBM-programm RANDU, arithmetic mean and simple standard deviations were calculated for: substance turn over, analytical concentration, temperatur, humidity, body weight gain
the statistics for the body weights were done by U-test (Mann and Whitney 1947) with modifications (Walter 1851) with alpha= 1% or 5%
ANOVA and Box-test
clinical findings: arithmetic mean and simple standard deviation, U-Test
dissection: Chi-square and Fisher-test
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- effects observed, treatment-related
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- CLINICAL SIGNS AND MORTALITY: Clinical symptoms (cyanosis, tremor, impairment of motions and of some reflexes) were observed in the
mid-dose group (female) and, more severe, the high-dose groups (both sexes, stronger in females).
No mortality was observed during the study.
BODY WEIGHT AND WEIGHT GAIN: Reduced body weight gains in the male high-dose group only.
OPHTHALMOSCOPIC EXAMINATION: One female in the high dose group displayed an ambilateral subcapsular cataract
HAEMATOLOGY: Decrease in erythrocytes, hemoglobin level and hematocrit; increased methemoglobin
(max. 3.3-11.7% in week 1), Heinz bodies (max. 0.1-0.7% in week 1) and reticulocytes;
observed in all treated female groups and both higher-dose male groups, dose-dependant.
CLINICAL CHEMISTRY: total and urinary bilirubin increased; triglycerides, cholesterol and serum cholinesterase reduced;
enhanced activity of liver monooxygenase, observed partly in mid-dose groups and generally in
high-dose groups, females being affected more strongly.
URINALYSIS: Females in the high dose group displayed higher bilirubin and protein excretion and a lower pH
NEUROBEHAVIOUR: two females in the high dose group lost their myotatic reflex in week 3 and one of those was less
sensible to external stimuli, no other influence was observed
ORGAN WEIGHTS: dose-dependant increase of spleen weight (low-dose/both);
GROSS PATHOLOGY / dark-red coloured spleen (mid-dose/both); deposition of hemosiderin in spleen (mid-dose/male);
HISTOPATHOLOGY positive hemosiderin test (all groups); dose dependant increase of macroblasts and normoblasts
in the bone marrow. The major influence seems to be a damage of the erythrocytes; no cumulative
effects were noted.
Effect levels
- Dose descriptor:
- NOEC
- Effect level:
- ca. 6.4 mg/m³ air
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Applicant's summary and conclusion
- Executive summary:
Märtins, T (1992)
The subacute inhalative toxicity of o-chloraniline vapours was tested with a head/nose exposure apparatus in male and female Wistar rats according to OECD 412 and EU method B.8 for 6 h/day during 28 d. Three dose groups and one concurrent control group with 10 animals per sex were established. The concentrations were analytical verified and were 0, 39, 217 and 886 mg o-chloroaniline /m³. No mortality was observed. Clinical symptoms mainly cyanosis were observed in females of the mid-dose group and males and females of the high-dose group . Only the males in the high-dose group displayed a reduced weight gain. Dose-dependent hematological changes were evident in all treated females (varying degree) and in the male rats of the mid- and high-dose group. They included a reduction in erythrocyte count as well as hemoglobin and an increase in methemoglobin, heinz-bodies and reticulocytes. In the high-dose group liver-monooxygenase activity was increased and the excretion of bilirubin and protein via urine was elevated.The spleen weight increased dose-dependently. The liver weight was increased in the high-dose group. The spleen was of a dark-red colour in the mid- and high-dose group with hemosiderin accumulation and higher blood volume. The bone marrow of all exposed groups displayed an dose-dependent increase in normo- and macroblasts.
The study clearly shows, that the destruction of erythrocytes is the primary toxic effect of o-chloraniline. As this effect is already evident (increased spleen weight, and changes in blood parameters and bone marrow composition) in the lowest tested dose of 39 mg/m³ a NOEC of 6 mg/m³ was extrapolated.
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