Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

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.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Diphenyl Oxide, 4%

In vivo test system

Test animals

Species:
human
Sex:
male
Details on test animals and environmental conditions:
Twenty five healthy adult males served as subjects.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
4%
Challengeopen allclose all
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

Study design: in vivo (LLNA)

Statistics:
None

Results and discussion

Positive control results:
No data

In vivo (non-LLNA)

Resultsopen allclose all
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.

Any other information on results incl. tables

None

Applicant's summary and conclusion

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.