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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
Epidemiological data
Administrative data
- Endpoint:
- epidemiological data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 004
- Reference Type:
- publication
- Title:
- The No-effect dose of aniline in human subjects and a comparison of aniline toxicity in man and the rat
- Author:
- Jenkins FP, Robinson JA, Gellatly JB, Salmond GW.
- Year:
- 1 972
- Bibliographic source:
- Food Cosmet Toxicol. 10, 671-679
Materials and methods
- Study type:
- other: oral exposure study with volunteers
- Endpoint addressed:
- acute toxicity: oral
- Principles of method if other than guideline:
- The effects of oral administration of aniline have been investigated in human volunteers.
- GLP compliance:
- no
Test material
- Reference substance name:
- Aniline
- EC Number:
- 200-539-3
- EC Name:
- Aniline
- Cas Number:
- 62-53-3
- Molecular formula:
- C6H7N
- IUPAC Name:
- aniline
- Details on test material:
- - Name of test material (as cited in study report): aniline,
- Supplier: Hopkin and Williams Ltd. Chadwell Heath, Essex
- Analytical purity: no data; redistilled
Constituent 1
Method
- Type of population:
- other: 20 healthy volunteers, age 22 - 45 yr
- Ethical approval:
- not specified
- Details on study design:
- The volunteers consisted of 17 males and 3 females ranging in age from 22 to 45 yr. A health.check prior to the investigation included tne examination of urine and blood samples. Urine samples were examined for glucose and protein. Blood samples were examined for evidence of a deficiency of erythrocyte glucose-6-phosphate dehydrogenase by means of the in vito test of BeutIer et al (1955). Erythrocyte sedimentation rate, packed cell volume, percentage of reticulocytes and the differential white cell count were also examined.
Oral doses of 5, 15 and 25 mg aniline, respectively, were administered at 10 a.m. on three successive days to each of 20 volunteers. Higher doses of
aniline (35, 45, 55, and 65 mg ) were then administered to some of these volunteers
METHOD OF DATA COLLECTION
Blood was taken 1, 2,3, 4 and 24 hours after application in order to analyse methaemoglobin levels according to the method of Fleisch (1959) as well as Heinz bodies, packed cell volume, percentage reticulocytes, total serum proteins, serum albumin, globulin, glutamic-oxalacetic and glutamic-pyruvic transaminases and alkaline phosphatase, total serum bilirubin, direct-reading bilirubin and blood urea. Urine was sampled and tested for urobilinogen, glucose and protein; thymol turbidity test.
In order to investigate the mechanism of methaemoglobin formation, blood samples were obtained from six male and six female human volunteers and the effects of phenylhydroxylamine (a metabolite of aniline) and glucose were measured in vitro. - Exposure assessment:
- not specified
- Details on exposure:
- TYPE OF EXPOSURE: oral, bolus dose
EXPOSURE LEVELS: Doses of 5, 15 and 25 mg aniline were administered on three successive days to each of 20 volunteers.
Results and discussion
- Results:
- Screening tests before administration of aniline revealed no evidence of deficiency of red cell glucose-6-phosphate dehydrogenase in aiiy of the volunteers and no other abnormalities were detected in their blood and urine samples. Blood samples taken 24 hr after each dose of aniline revealed no adverse effect upon packed cell volume, reticulocyte count, bilirubin or urobilinogen, except for a slight increase of serum bilirubin in two males following the administration of high doses of aniline, namely 45 and 65 mg.
Aniline had no adverse effect on serum proteins, serum enzymes, blood urea or the thymol turbidity test. No Heinz bodies were detected and the examination of blood films and buffy coat preparations revealed no abnormal features.
The mean maximum increase in percentage of methaemoglobin (MetHB) was obtained in less than 4 hours after intake. Doses of 5 and 15 mg aniline produced no significant increase of methaemoglobin but the dose of 25 mg raised the level to 2.5% versus 1.2/1.8% in the lower doses. 35 mg/person led to a maximal increase of MetHb of 3.7%.
The dose of 45 mg raised the level to 7% (5 volunteers) and one volunteer who received a dose of 65 mg had a level of 16% Met-Hb two hours after administration but one hour later the level was within normal limits. The blood samples taken 24 hours after each dose revealed no adverse effects upon packed cell volume, reticulocyte count, bilirubin or urobilinogen, except for a slight increase of serum bilirubin in two male volunteers following the administration of 45 and 65 mg (0.6 and 0.9 mg/kg bw, respectively). Aniline had no adverse effects on serum proteins, serum enzymes, blood urea and thymo turbidity test. No Heinz bodies were detected. The authors conclude that this investigation supports the view that the production of methaemoglobin is due to a metabolite of aniline, namely phenylhydroxylamine (measured in the blood in vitro), and that the catalytic effect of phenylhydroxylamine is promoted by glucose.
The no-effect dose of aniline in adult man is in the region of 15 mg/man (about 0.21 mg/kg body weight). Based on a MetHb increase of 3.7%, which is considered as uncritical for humans, the NOAEL of the study was 35 mg/man.
Any other information on results incl. tables
Table 1. Maximum increase in methemoglobin following oral administration of aniline to men
Dose (mg) | No. of volunteers tested | Mean maximum increase of MetHB in % |
5 | 20 | 1.16 |
15 | 20 | 1.81 |
25 | 20 | 2.46 |
35 | 5 | 3.68 |
45 | 5 | 7.08 |
55 | 2 | 5.17 |
65 | 1 | 16.11 |
Applicant's summary and conclusion
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