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EC number: 200-539-3 | CAS number: 62-53-3
- 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
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 October 2001- 5 June 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
- Reference Type:
- publication
- Title:
- High-dose clastogenic activity of aniline in the rat bone marrow and its relationship to the carcinogenicity in the spleen of rats
- Author:
- Bomhard EM
- Year:
- 2 003
- Bibliographic source:
- Arch. Toxicol. 77, 291-297
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Anilinium chloride
- EC Number:
- 205-519-8
- EC Name:
- Anilinium chloride
- Cas Number:
- 142-04-1
- IUPAC Name:
- anilinium chloride
- Reference substance name:
- aniline, hydrochloride
- IUPAC Name:
- aniline, hydrochloride
- Details on test material:
- - Name of test material (as cited in study report): Aniline hydrochloride
- Substance type: white crystalline
- Physical state: crystalline solid
- Analytical purity: 100% w/w
- Purity test date: 10 September 1999 and 10 April 2002
- Lot/batch No.: 99-048
- Storage condition of test material: Ambient temperature (under N2)
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: PVG
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan (Bicester, UK)
- Age at study initiation: 9-11 weeks
- Housing: 3-4 per cage
- Diet (e.g. ad libitum): Rat and Mouse No. 1 Maintenance Diet; Special Diets Services, Witham, UK
- Water (e.g. ad libitum): tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30-70%
- Air changes (per hr): 15 times/hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: no data
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Application volume in each case was 10 ml/kg body weight; no further specification - Duration of treatment / exposure:
- single dose
- Frequency of treatment:
- single dose
- Post exposure period:
- Up to 48 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
300, 400 and 500 mg/kg
Basis:
actual ingested
- No. of animals per sex per dose:
- 7
- Control animals:
- other: vehicle and positive control
- Positive control(s):
- cyclophosphamide
- Justification for choice of positive control(s): positive in micronucleus test
- Route of administration: oral
- Doses / concentrations: 3 animals received a single oral administration of 7.5 mg cyclophosphamide/kg body weight; these animals were killed and the bone marrow sampled 24 h later.
Examinations
- Tissues and cell types examined:
- polychromatic and normochromatic erythrocytes of the bone marrow
- Details of tissue and slide preparation:
- TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):
sampling after 24 and 48 h in test groups, 24 hr in positive control group. For each animal both femurs were removed and stripped clean of muscle. The iliac end of the femur was removed and a fine paintbrush was rinsed in saline, wiped to remove the excess and wetted with a solution of albumin (6% w/v in physiological saline)
DETAILS OF SLIDE PREPARATION:
The iliac end of the femur was then dipped into the marrow canal and four smears were painted on a slide. Four slides were prepared for each animal. Initially, one slide from each animal was dipped in phosphate buffer then stained with a solution of acridine orange for 1 min, placed in phosphate buffer for 10 min and then in a fresh batch of buffer for a further 15 min. After staining, the des were air-dried and wet-mounted in buffer prior to analysis. Additional slides were stained for animals for which extended analysis was require
METHOD OF ANALYSIS:
The incidence of micronucleated immature erythrocytes per 1000 immature erythrocytes and the percentage of immature erythrocytes in the erythrocyte sample were evaluated by analysis of variance, separately at 24 and 48 h.
Slides were coded and scored blind. Initially for each animal, 2000 (2 x 1000) immature erythrocytes were examined for the presence of micronuclei. The slides were also examined for evidence of cytotoxicity, which may be manifest by alterations in the ratio of different cell types in the bone marrow. This was assessed by determining the ratio of immature to mature erythrocytes in a sample of 1000 erythrocytes. To investigate increases in the incidence of micronucleated immature erythrocytes at the 24-h-sampling time, a further 2000 (2 x 1000) immature erythrocytes were examined on slides from animals treated with the vehicle control and aniline hydrochloride at 500 mg/kg at the 24-h sampling time. - Evaluation criteria:
- Each treatment group mean was compared with the control group mean at the corresponding sampling time using a one-sided Student's t-test, based on the error mean square in the analysis. The criteria for identification of cell types and micronuclei are based on those of Tinwell and Ashby (1989).
- Statistics:
- ANOVA; the data for the incidence of micronucleated immature erythrocytes were transformed using a square-root transformation, prior to analysis. The data for the percentages of immature erythrocytes were transformed using the double-arcsine transformation of Freeman and Tukey prior to analysis. Analyses were carried out separately for the aniline hydrochloride-treated groups and positive control group using the MIXED procedure in SAS software. Each treatment group mean was compared with the control group mean at the corresponding sampling time using a one-sided Student's t-test, based on the error mean square in the analysis.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- positive
- Remarks:
- at 400 and 500 mg/kg bw, sampling time 24 h
- Toxicity:
- yes
- Remarks:
- cyanosis at all dose levels
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
Any other information on results incl. tables
Toxicity:
The clinical signs of animals dosed with 300 mg/kg and above included cyanosis, coloured urine (light brown) and being cold to touch. Examinations of the internal organs showed no abnormalities. None of the animals died during the observation period. The clinical signs indicate that the dose levels chosen can be considered to be in the range of the maximum tolerated dose of aniline hydrochloride for the route of administration used.
Genetic toxicity:
The group means incidences of micronucleated immature erythrocytes together with the percentages of immature erythrocytes are shown in Table 1. A small but statistically significant and dose-related increase in the incidence of micronucleated immature erythrocytes over the vehicle control values was observed at the 24-h sampling time. No such increase was observed at the 48-h sampling time. No statistically significant differences in the percentage of immature erythrocytes between the vehicle control and aniline hydrochloride-treated animals were observed at either sampling time. The test system positive control, cyclophosphamide, induced statistically significant increases in the frequency of micronucleated immature erythrocytes at the 24-h sampling time. One of the three animals of this group was a non-responder for unknown reasons.
Table 1a: Mean incidence of micronucleated immature erythrocytes
Treatment |
Dose (1) |
Mean icidence of MPE/1000 IE ± SD |
|
24 h |
48 h |
||
Aniline hydrochloride |
500 mg/kg |
4.9 ± 2.2 |
2.1 ± 0.9 |
400 mg/kg |
3.0 ± 2.2 |
2.0 ± 0.8 |
|
300 mg/kg |
2.7 ± 1.6 |
2.5 ± 0.7 |
Increase was statistically significant
Table 1b: Mean percentage of immature erythrocytes
Treatment |
Dose (1) |
% Immature erythrocytes ± SD |
|
24 h |
48 h |
||
Aniline hydrochloride |
500 mg/kg |
50.3±1.0 |
38.7±12.1 |
400 mg/kg |
37.8±12.3 |
44.9±5.9 |
|
300 mg/kg |
48.2±18.4 |
52.6±7.1 |
(1) dose expressed in terms of aniline base
IE = immature erythrocytes, MPE = micronucleated immature erythrocytes, SD = Standard deviation
Applicant's summary and conclusion
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