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Diss Factsheets
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EC number: 203-581-0 | CAS number: 108-42-9
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- fertility, other
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
Materials and methods
- Principles of method if other than guideline:
- Groups of 10 male and 10 female F344/N rats were administered 0, 10, 20, 40, 80, or 160 mg m-chloroaniline per kilogram body weight in dilute hydrochloric acid by gavage 5 days a week for 13 weeks. Animals were evaluated for hematology, clinical chemistry, histopathology, and reproductive system effects. Histopathological evaluations were performed on all animals in the vehicle control and 160 mg/kg groups. The following reproductive tissues/organs were examined: testes (with epididymis), prostate gland, seminal vesicle, uterus, vagina, clitoral glands, ovaries and mammary gland. additionally sperm motility and vaginal cytology were examined.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-chloroaniline
- EC Number:
- 203-581-0
- EC Name:
- 3-chloroaniline
- Cas Number:
- 108-42-9
- Molecular formula:
- C6H6ClN
- IUPAC Name:
- 3-chloroaniline
- Test material form:
- other: liquid
- Details on test material:
- m-chloroaniline, a pale yellow liquid, was identified by infrared spectroscopy; each spectrum was consistent with a literature reference (Aldrich Library of FT-IR Spectra, 1985) and with that expected for the chemical structure. Gas chromatography indicated a purity greater than 99%.
Boiling Point: 230.5°C
Density at 22°C: 1.210
Vapor pressure: <0.1 mmg Hg at 30°C
Solubility: practically insoluble in water, soluble in organic solvents
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1 M hydrochloric acid
- Details on mating procedure:
- not applicable - subchronic study
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 5 days a week for 13 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 10, 20, 40, 80, or 160 mg m-chloroaniline per kilogram body weight
Basis:
nominal conc.
- No. of animals per sex per dose:
- 10 male and 10 female rats/dose
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 160 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No relevant adverse effects on reproductive tissues/organs and sperm motility or vaginal cytology were detected at the highest applied dose (160 mg/kg bw/d).
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
No relevant adverse effects on reproductive tissues/organs and sperm motility or vaginal cytology were detected at the highest applied dose (160 mg/kg bw/d).
Applicant's summary and conclusion
- Executive summary:
Groups of 10 male and 10 female F344/N rats were administered 0, 10, 20, 40, 80, or 160 mg m-chloroaniline per kilogram body weight in dilute hydrochloric acid by gavage 5 days a week for 13 weeks. Animals were evaluated for hematology, clinical chemistry, histopathology, and reproductive system effects. Histopathological evaluations were performed on all animals in the vehicle control and 160 mg/kg groups. The following reproductive tissues/organs were examined: testes (with epididymis), prostate gland, seminal vesicle, uterus, vagina, clitoral glands, ovaries and mammary gland. additionally sperm motility and vaginal cytology were examined.
No adverse effects on reproductive tissues/organs and sperm motility or vaginal cytology evaluations were detected at the highest applied dose (160 mg/kg bw/d)
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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