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Diss Factsheets
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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
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- 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
- Endpoint addressed:
- basic toxicokinetics
- Principles of method if other than guideline:
- study on human volunteers, no guideline followed
- 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
- Analytical purity: no data (redestilled)
Constituent 1
Method
- Ethical approval:
- not specified
- Details on study design:
- Effects of aniline ingestion on hematotoxicity was examined in 20 human volunteers/17 males and 3 females). Doses of 5, 15 and 25 mg aniline, respectively, were administered on three consecutive days to each of 20 volunteers. Higher doses of aniline, i.e. 35, 45, 55, 65 mg were then administered to 5, 5, 2, 1 of these volunteers, respectively.
Results and discussion
- Results:
- Following oral administration of aniline to human volunteers a dose dependent increase in the percentage of MetHb was observed. Maximum increase in MetHb was observed after 1 - 4 hours. The no-effect dose in this study was 15 mg/man based on the lack of hematotoxicity (increase in MetHb level, formation of Heinz bodies). Based on the MetHb increase of 3.7% the NOAEL of the study was 35 mg/man.
Any other information on results incl. tables
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 45 and 65 mg aniline. 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. No significant increase in MetHb was observed 1, 2 and 3 h after application of 5 mg and 15 mg aniline. After exposure to 25 mg aniline an increase in MetHb of 2.5% versus 1.2/1.8% in the two lower doses was observed. Exposure to 45 mg aniline lead to an increase in MetHb level of 7% (5 volunteers) and one volunteer who received a dose of 65 mg had a level of 15% Met-Hb. The mean maximum increase in MetHb was observed in less than 4 hours after intake. The no-effect dose of aniline in adult man in this study is 15 mg/man. The NOAEL was determined with 35 mg/man.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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