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EC number: 204-539-4 | CAS number: 122-39-4
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation, other
- Type of information:
- other: risk assessment report
- Adequacy of study:
- weight of evidence
- Study period:
- May 2008
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Secondary literature: European Union Risk Assessment Report Diphenylamine
- Justification for type of information:
- European Union Risk Assessment Report DIPHENYLAMINE
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- There was an outbreak of dermatitis in a group of 16 men involved in the quality control and analysis of fine organic chemicals, including diphenylamine. Eleven of the workers (the remaining four people were tested with another substance) were patch tested with a concentration of 1% diphenylamine in methanol.
- GLP compliance:
- not specified
- Type of study:
- other: patch test
- Specific details on test material used for the study:
- No information available.
- Species:
- other: human
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No information available.
- Positive control results:
- No information available.
- Key result
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- There was an outbreak of dermatitis in a group of 16 men involved in the quality control and analysis of fine organic chemicals, including diphenylamine. Eleven of the workers (the remaining four people were tested with another substance) were patch tested with a concentration of 1% diphenylamine in methanol. None of the workers showed a positive response.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- There was an outbreak of dermatitis in a group of 16 men involved in the quality control and analysis of fine organic chemicals, including diphenylamine. Eleven of the workers (the remaining four people were tested with another substance) were patch tested with a concentration of 1% diphenylamine in methanol. None of the workers showed a positive response.
- Endpoint:
- skin sensitisation, other
- Remarks:
- in vivo
- Type of information:
- other: risk assessment report
- Adequacy of study:
- weight of evidence
- Study period:
- May 2008
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Secondary litterature: European Union Risk Assessment Report DIPHENYLAMINE
- Justification for type of information:
- European Union Risk Assessment Report DIPHENYLAMINE
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- There is no information about the possible application of the test according to a guideline in this report
- GLP compliance:
- not specified
- Type of study:
- not specified
- Justification for non-LLNA method:
- No information available.
- Specific details on test material used for the study:
- No information available.
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No information available.
- Positive control results:
- No information available.
- Key result
- Remarks on result:
- no indication of skin sensitisation
- Cellular proliferation data / Observations:
- No information available.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Diphenylamine (purity 99.9%) did not produce dermal sensitization in guinea pigs
- Endpoint:
- skin sensitisation, other
- Remarks:
- Human patch test.
- Type of information:
- other: risk assessment report
- Adequacy of study:
- weight of evidence
- Study period:
- May 2008
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Secondary litterature: European Union Risk Assessment Report DIPHENYLAMINE
- Justification for type of information:
- European Union Risk Assessment Report DIPHENYLAMINE
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A 44-year-old woman who worked in a circuit braker factory handling metals, plastics and greases had a vesicular and exudative eczema on the back of her hands. A patch test was performed.
- GLP compliance:
- not specified
- Type of study:
- other: patch test
- Specific details on test material used for the study:
- No information available.
- Species:
- other: human
- Strain:
- not specified
- Sex:
- female
- Details on test animals and environmental conditions:
- No information available.
- Positive control results:
- No information available.
- Key result
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- A 44-year-old woman who worked in a circuit braker factory handling metals, plastics and greases had a vesicular and exudative eczema on the back of her hands. Patch testing (test concentration 1%, vehicle not mentioned) revealed a positive response to diphenylamine but not to p-phenylenediamine.
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information based on the result of one woman
- Conclusions:
- A 44-year-old woman who worked in a circuit braker factory handling metals, plastics and greases had a vesicular and exudative eczema on the back of her hands. Patch testing (test concentration 1%, vehicle not mentioned) revealed a positive response to diphenylamine but not to p-phenylenediamine.
- Endpoint:
- skin sensitisation, other
- Remarks:
- Human patch test
- Type of information:
- other: risk assessment report
- Adequacy of study:
- weight of evidence
- Study period:
- May 2008
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Secondary litterature: European Union Risk Assessment Report DIPHENYLAMINE
- Justification for type of information:
- European Union Risk Assessment Report DIPHENYLAMINE
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A total of 1012 eczema patients were patch tested in nine cities (test concentration: 1% in petrolatum). There were three positive patients
in one city. These patients were all known to be positive to p-phenylenediamine and the reactions were regarded as cross sensitivities (with Diphenylamine). - GLP compliance:
- not specified
- Type of study:
- other: patch test
- Specific details on test material used for the study:
- No information available.
- Species:
- other: human
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No information available.
- Positive control results:
- No information available.
- Key result
- Run / experiment:
- other: other:
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- A total of 1012 eczema patients were patch tested in nine cities (test concentration: 1% in petrolatum). There were three positive patients in one city. These patients were all known to be positive to p-phenylenediamine and the reactions were regarded as cross sensitivities. It is mentioned that exposure is possible due to the use of perfume ingredients where diphenylamine is included at a concentration of 0.1%.
- Interpretation of results:
- ambiguous
- Remarks:
- Migrated information
- Conclusions:
- A total of 1012 eczema patients were patch tested in nine cities (test concentration: 1% in petrolatum). There were three positive patients in one city. These patients were all known to be positive to p-phenylenediamine and the reactions were regarded as cross sensitivities. It is mentioned that exposure is possible due to the use of perfume ingredients where diphenylamine is included at a concentration of 0.1%.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- in vivo
- Type of information:
- other: risk assessment report
- Adequacy of study:
- weight of evidence
- Study period:
- May 2008
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Secondary literature: European Union Risk Assessment Report Diphenylamine
- Justification for type of information:
- European Union Risk Assessment Report DIPHENYLAMINE
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A maximization test was performed on 30 volunteers ((test concentration 1% in petrolatum)
- GLP compliance:
- not specified
- Type of study:
- other: Maximization test
- Justification for non-LLNA method:
- Secondary literature: European Union Risk Assessment Report Diphenylamine to which information was obtained from a publication dated 1978
- Specific details on test material used for the study:
- No information available.
- Species:
- other: human
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No information available.
- No. of animals per dose:
- No information available.
- Details on study design:
- No information available.
- Challenge controls:
- No information available.
- Key result
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- A maximization test carried out on 30 volunteers produced no sensitization reactions (test concentration 1% in petrolatum)
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- A maximization test carried out on 30 volunteers produced no sensitization reactions (test concentration 1% in petrolatum)
Referenceopen allclose all
No detailed results are given in this report
No detailed result is available in this report.
No detailed results are given in this report
No detailed results are given in this report
No detailed results are given in this report
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Diphenylamine (purity 99.9%) did not produce dermal sensitization in guinea pigs (Kiplinger, 1995, as cited in JMPR report, 1998). There is one case of one woman where a contact allergy could be demonstrated. Other studies with 11 or 1012 patients did not demonstrate a skin sensitization that could be attributed to diphenylamine. Cross sensitization to pphenylenediamine has not been demonstrated in the woman who reacted positive to diphenylamine and cross sensitivities were suspected in three positive patients. In a maximization test carried out on 30 volunteers no sensitization reactions were produced. These data demonstrate that in humans the substance has a weak or no sensitizing potential.
Migrated from Short description of key information:
This information is based on a secondary source (European Union Risk Assessment Report Diphenylamine 2008) with consistent values for skin sensitisation.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available information classification as a skin sensitiser is not required in accordance with Regulation 1272/2008 (CLP)
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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