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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a standard method but was non-GLP.
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
no guideline followed
Principles of method if other than guideline:
The Maximization Test (J. I. D. ; Vol. 47; #5; 1966) was utilized.
GLP compliance:
no
Type of study:
other: The Maximization Test
Species:
human
Sex:
male
Details on test animals and environmental conditions:
Twenty five healthy adult males served as subjects.
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
4%
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
4%
No. of animals per dose:
25
Details on study design:
The test material was mixed into petrolatum N. F. at the indicated concentration. The test material was applied to the same forearm sites under occlusion for five alternate-day 48-hour periods. Each application of the test material was preceded by treatment of the patch site with 5% aqueous sodium lauryl sulfate under occlusion. Following a ten day rest period challenge patches of the test material were applied to fresh sites on the scapular backs under occlusion for 48 hours. The challenge sites were pretreated for one hour with 10% aqueous sodium lauryl sulfate. Clinical evaluations were made at 48 and 72 hours.
Challenge controls:
None
Positive control substance(s):
no
Statistics:
None
Positive control results:
No data
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
4%
No. with + reactions:
0
Total no. in group:
25
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 4%. No with. + reactions: 0.0. Total no. in groups: 25.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
4%
No. with + reactions:
0
Total no. in group:
25
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 4%. No with. + reactions: 0.0. Total no. in groups: 25.0.

None

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Diphenyl oxide did not produce any cases of contact allergy.
Executive summary:

Diphenyl oxide was evaluated for sensitization in humans following the Maximization Test (J.I.D., Vol. #5, 1966). The test material was mixed into petrolatum N. F. at 4% concentration. The test material was applied to the same forearm sites under occlusionfor five alternate-day 48-hour periods. Each application of the test material was preceded by treatment of the patch site with 5% aqueous sodium lauryl sulfate under occlusion. Following a ten day rest period challenge patches of the test material were applied to fresh sites on the scapular backs under occlusion for 48 hours.The challenge sites were pretreated for one hour with 10% aqueous sodium lauryl sulfate. Clinical evaluations were made at 48 and 72 hours.

Diphenyl oxide did not produce any cases of contact allergy.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There are two available studies for this material. Neither study is reported in great detail; however the results are sufficient to make a judgment on whether this material is a sensitiser.

In the Human patch test 25 male volunteers were exposed dermally to 4% DPO. This did not produce any evidence of a sensitising response in any of the volunteers.

In the Guinea pig study, none of the animals were sensitised to DPO at concentrations up to 40% with a 10% induction dose. However, only 5 animals were used in the test group and 2 animals in the control group. The study was clearly negative, but the sample size was smaller than the current guideline (10 test and 5 control animals).

Whilst neither study is particularly robust, the overall weight of evidence is that this substance is not considered as a sensitiser.


Migrated from Short description of key information:
Human Patch test
Guinea Pig maximisation test

Justification for selection of skin sensitisation endpoint:
study results in the target, human population.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No data are available for the assessment of respiratory sensitising potential. However, this substance does not appear to be a skin sensitiser and so it is unlikely that it would be a respiratory sensitiser.


Migrated from Short description of key information:
No data

Justification for classification or non-classification

DPO is not classified as a sensitiser.