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Diss Factsheets

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

Referenceopen allclose all

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).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

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

There is no detailed result in this report

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.

There is no detailed result in this report

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.
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