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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
Skin and eye irritations:
These informations are based on a secondary source (European Union Risk Assessment Report Diphenylamine 2008) with consistent values for skin and eye irritations.
Eye irritation:
Diphenylamine (purity, 99.9-100.1%) applied to the eyes of one rabbit for seven days without rinsing (Kreuzmann, 1991a).
An other eye irritation test with 0.1 g purified diphenylamine in 6 albino rabbits (Elf Atochem North America Inc. 1994b, study dated from 1982) wasconducted according EPA guideline.
A Draize eye irritation test was performed after instillation of 50 mg of the substance into the eyes of 2 rabbits (Bayer AG 1977).
According to a QSAR approach, DPA appears to be highly irritant to eyes (Sugai 1990).
Skin irritation:
Diphenylamine (purity, 99.9-100.1%) applied to the skin of one rabbit for seven days without rinsing (Kreuzmann, 1991b).
Skin irritation potential of diphenylamine (no data on purity) was tested in the inner surface of the ears of two Albino rabbits by means of occlusive application of the substance for 24 hours (Bayer AG 1977).
In a primary skin irritation test with purified diphenylamine in albino rabbits (Elf Atochem North America Inc. 1994a, study dated from 1982), conducted according EPA guideline, 0.5 g diphenylamine was applied on two intact and two abraded skin sites of each six rabbits, with 24h of exposure period.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: 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
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Reversibility:
- no data
- Remarks on result:
- other: no signs of irritation observed within a 7 days observation period
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Diphenylamine caused no or only very slight skin irritation in tests with rabbits: Skin irritation potential of diphenylamine (no data on purity) was tested in the inner surface of the ears of two Albino rabbits by means of occlusive application of the substance for 24 hours (no information whether a vehicle was used or not used). There were no signs of irritation observed within a 7 days observation period.
- Endpoint:
- skin irritation: 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
- 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
- Reversibility:
- no data
- Remarks on result:
- other: no skin irritation of diphenylamine in rabbits
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- This study revealed no skin irritation of diphenylamine (purity, 99.9-100.1%) in rabbits.
- Endpoint:
- skin irritation: 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
- Qualifier:
- according to guideline
- Guideline:
- other: EPA guideline
- GLP compliance:
- not specified
- Reversibility:
- no data
- Remarks on result:
- other: After 24 hours occlusive exposure, mild effects were observed. At the final 72 hours reading, 6 out of 24 application sites showed very slight edema (grade 1).
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EPA guideline
- Conclusions:
- In a primary skin irritation test with purified diphenylamine in albino rabbits, conducted according EPA guideline, 0.5 g diphenylamine was applied on two intact and two abraded skin sites of each six rabbits. After 24 hours occlusive exposure, mild effects were observed. At the final 72 hours reading, 6 out of 24 application sites showed very slight edema (grade 1).
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: 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
- Qualifier:
- according to guideline
- Guideline:
- other: EPA guideline
- GLP compliance:
- not specified
- Irritation parameter:
- other: conjunctival erythema
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 1.2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- other: conjunctival erythema
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 1.2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- other: conjunctival erythema
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- In this eye irritation test with 0.1 g purified diphenylamine in 6 albino rabbits, conducted according EPA guideline, mild-moderate effects were observed.
After 24 hours, mild iritis (in one animal only, score = 1) and mild-moderate conjunctivitis occurred. Averaged Draize scores for conjunctival erythema, 24/48/72 hours- 4/7 days: 1.2/1.2/1- 0.4/0.2 and for conjunctival chemosis: 1/1/0.5- 0.5/0.2, respectively.
During the course of the observation period, these effects cleared up gradually. After 10 days, all treated eyes were normal again. - Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: unsuitable test system
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Chemicals were placed into conjunctival sac of the left eye. The eyes were examined and the grade of ocular reaction recorded at differents times after treatment. Ocular reactions were classified according to Draize score, and EPA toxicity categories were used for the classification of chemicals
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Takeo breeder (Shizuoka, Japan)
- Weight at study initiation: 2.0-2.2 kg
- Housing: metal cages 39x40x44 cm
- Diet (e.g. ad libitum): RC4 diet (Oriental yeast Co, Tokyo, Japan)
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25
- Humidity (%): 55
- Photoperiod (hrs dark / hrs light):12/12 - Vehicle:
- not specified
- Controls:
- other: right eye served as a blank
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):100 mg
- Concentration (if solution):0.1 ml - Duration of treatment / exposure:
- 21 days
- Observation period (in vivo):
- 1, 4, 24, 48, 72 and 96 hours, 7, 14 and 21 days
- Number of animals or in vitro replicates:
- 3 animals per chemical
- Irritation parameter:
- overall irritation score
- Basis:
- other:
- Time point:
- other: 21 days
- Score:
- > 16.9 - < 96.8
- Max. score:
- 96.8
- Reversibility:
- not fully reversible within:
- Remarks:
- 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24 h
- Reversibility:
- not specified
- Remarks on result:
- other: Not specified
- Remarks:
- Not specified
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- other: Not specified
- Remarks:
- Not specified
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 72 h
- Reversibility:
- not specified
- Remarks on result:
- other: Not specified
- Remarks:
- Not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24 h
- Reversibility:
- not specified
- Remarks on result:
- other: Not specified
- Remarks:
- Not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- other: Not specified
- Remarks:
- Not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 72 h
- Reversibility:
- not specified
- Remarks on result:
- other: Not specified
- Remarks:
- Not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Reversibility:
- not specified
- Remarks on result:
- other: Not specified
- Remarks:
- Not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- other: Not specified
- Remarks:
- Not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 72 h
- Reversibility:
- not specified
- Remarks on result:
- other: Not specified
- Remarks:
- Not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24 h
- Reversibility:
- not specified
- Remarks on result:
- other: Not specified
- Remarks:
- Not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- other: Not specified
- Remarks:
- Not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 72 h
- Reversibility:
- not specified
- Remarks on result:
- other: Not specified
- Remarks:
- Not specified
- Irritant / corrosive response data:
- scores 0 up to 7.0: class I (mild) of chemicals inducing no or mild damage recovering within 24 hours (23 chemicals)
scores 1.0 up to 42.8: class II (moderate to severe) of chemicals inducing severe irritation clearing within 21 days (64 chemicals)
scores 16.9 up to 96.8 : class III (corrosive) of chemicals inducing corrosive effect not recovering within 21 days (44 chemicals including diphenylamine) - Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: other: modified EPA toxicity categories (1991)
- Conclusions:
- Diphenylamine is corrosive to the eye of rabbits
- Endpoint:
- eye irritation: 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 2008
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Irritation parameter:
- other: chemosis score and conjunctivae score
- Basis:
- mean
- Time point:
- other: no data
- Reversibility:
- not specified
- Remarks on result:
- other: One of the animals demonstrated slight to moderate conjunctival irritation (redness and edema) within a 7 days observation period
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Moderate conjunctival irritation was detected in a Draize eye irritation test after instillation of 50 mg of the substance into the eyes of 2 rabbits. One of the animals demonstrated slight to moderate conjunctival irritation (redness and edema) within a 7 days observation period.
There is no information on reversibility or irreversibility of these effects. - Endpoint:
- eye irritation: 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
- 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
- Irritation parameter:
- other: no data
- Time point:
- other: 7 days
- Reversibility:
- not specified
- Remarks on result:
- other: corrosivity and corneal opacity after application of 0.1 g diphenylamine to the eyes of one rabbit for seven days without rinsing.
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- In a JMPR report (1998) was mentioned that Kreuzmann (1991, unpublished study) reported corrosivity and corneal opacity after application of 0.1 g
diphenylamine (purity 99.9-100.1%) to the eyes of one rabbit for seven days without rinsing.
Referenceopen allclose all
There is no detailed result in this report
There is no detailed result in this report
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Human data on local irritant or corrosive properties of diphenylamine are not available. The substance caused no or only very slight skin irritation in tests with rabbits.
Data on eye irritating properties of the substance are conflicting and poorly documented, but it may be assumed that diphenylamine may pose a risk of serious damage to eyes. There exist two studies (one with documented guideline-compliance), which both report severe eye irritation caused by diphenylamine. In one of these studies irreversibility of effects after 21 days is stated.
Effects on eye irritation: irritating
Justification for classification or non-classification
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.