Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1952
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study, no guideline followed

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1952
Reference Type:
secondary source
Title:
O-Phenylphenol and its Sodium and Potassium Salts: A Toxicological Assessment
Author:
Bomhard, E. M. et al.
Year:
2002
Bibliographic source:
Crit. Rev. Toxicol. 32(6):551-626

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
OPP was tested on 200 unselected human subjects (100 males and 100 females) by means of the repeated patch test.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
o-phenylphenol (OPP), purity > 98%, 5 % solution in sesame oil

Method

Type of population:
not specified
Subjects:
- Number of subjects exposed: 200 in total
- Sex: 100 males and 100 females
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Vehicle / solvent: 5 % solution in sesame oil
- Concentrations: Induction/Challenge: 5 %
- Testing/scoring schedule: DAy 1: application of first patch; Day 5 removal of patch and scoring; Day 21 application of second patch; Days 23/26/31 scoring

Results and discussion

Results of examinations:
OPP did not cause primary irritation when tested as a 5% solution in sesame oil nor did it cause any sensitisation.

Applicant's summary and conclusion

Conclusions:
not sensitising