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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

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.

No detailed results are given in this report

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.

No detailed result is available in this report.

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.

No detailed results are given in this report

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%.

No detailed results are given in this report

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)

No detailed results are given in this report

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)
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)