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EC number: 202-430-6 | CAS number: 95-54-5
- 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:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 969
- Report date:
- 1969
Materials and methods
- Principles of method if other than guideline:
- Male rats were exposed to 0.08 mg/L OPD via whole-body inhalation for four hours per day for 10 days. Gross and histopathological examinations were performed on 3 rats/group after the last exposure and 14 days post-exposure.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- o-phenylenediamine
- EC Number:
- 202-430-6
- EC Name:
- o-phenylenediamine
- Cas Number:
- 95-54-5
- Molecular formula:
- C6H8N2
- IUPAC Name:
- benzene-1,2-diamine
- Details on test material:
- o-phenylenediamine, purity approximately 98.5-99%
The test material could not be ground to a suitable particle size because of its physical characteristics. Therefore a regular dust exposure was not possible.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: ChR-CD
- Sex:
- male
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Method of holding animals in test chamber: 16-liter bell jar
- System of generating particulates/aerosols: The material could not be ground to a suitable particle size because of its physical nature. Regular dust exposure was not possible.
A weighed sample was put in a three-neck borosilicate glass flask in a heated (110-130'C) mineral oil bath. Aerosols were prepared with a stainless steel nebulizer submerged into the melt. Nitrogen was blown through the nebulizer to form fine particles. Diluted air and oxygen were added to the stream prior to entering the exposure chamber to give a 20% O2 atmosphere.
U.V. spectrophotometric analysis and filter paper were used to determine concentrations 4-6 times during exposure. Particle size distribution measurements were made with a Monsanto cascade impactor once for each exposure.
- Method of particle size determination: Airborne solids were measured in the exposure chamber by collecting solids of a known air volume on a Fiberglass filter of 0.1 µ pore size.
TEST ATMOSPHERE
- Brief description of analytical method used: 4-hour exposure carried out in a 16-liter bell jar.
Mass Median Diameter Dispersion
2.0-3.2 - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 4 hours per day
- Frequency of treatment:
- 10 days
Doses / concentrations
- Dose / conc.:
- 0.83 mg/L air (analytical)
- No. of animals per sex per dose:
- 6 per dose
- Control animals:
- other: Mixture of 2.4 L/min N2 + 0.6 L/min O2
- Details on study design:
- Post-exposure period: 14 days. Six control rats of the same strain and birth date were exposed to a mixture of 2.4 L/min N2 + 0.6 L/min O2 for the same period of time as the test animals.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Not reported
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Not reported
BODY WEIGHT: Yes
- Time schedule: Not reported
- Sacrifice and pathology:
- Gross and histopathological examinations were performed on 3 rats from each group (test and control) after the last exposure and 14 days post-exposure. Histopathological examination included the lungs, liver, kidney, brain, heart, lymph nodes, spleen, testes, gastrointestinal tract, thymus, thyroid, adrenal, skin, and bone marrow.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- Respiration was abnormal during exposure, but the test rats showed no other evidence of injury. Clinical signs noted during exposure included slight irregular respiration, not responsive to sound (sometimes), face pawing, hypersensitive to touch, mild facial alopecia. No clinical signs were noted during the post-exposure period.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Repeated exposure of a group of rats to 0.08 mg/L of o-phenylenediamine caused decreased growth rate during the period of exposure with normal rate of gain during a 14-day recovery period.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- Gross and histopathological examination of rats sacrificed after the last exposure and after the 14-day recovery revealed no evidence of tissue damage.
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Gross and histopathological examination of rats sacrificed after the last exposure and after the 14-day recovery revealed no evidence of tissue damage.
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- Gross and histopathological examination of rats sacrificed after the last exposure and after the 14-day recovery revealed no evidence of tissue damage.
Effect levels
- Dose descriptor:
- NOAEL
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
Male rats were exposed to 0.08 mg/L OPD four hours per day for 10 days. Decreased growth rate during the period of exposure was noted with a normal rate of weight gain during a 14-day recovery period. Irregular respiration was noted during the exposure but the rats showed no other clinical evidence of injury. No evidence of tissue damage was observed during the pathological examinations.
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