Registration Dossier

Toxicological information

Sensitisation data (human)

Currently viewing:

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: case reports; no details about exposure concentrations and duration. Also assessed by OECD.

Data source

Reference
Reference Type:
publication
Title:
Contact dermatitis from cellulose acetate film.
Author:
Hjorth N
Year:
1964
Bibliographic source:
Berufsdermatosen 12: 86-100

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
retrospective evaluation of 23192 human patch tests (between 1950 to 1962).
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 23192
- Other: retrospective evaluation
Clinical history:
no data
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive / semiocclusive /other:
- Description of patch: plastic discs
- Vehicle / solvent: TPP 10% in acetone
-

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 15 of 23192 patients

Applicant's summary and conclusion

Conclusions:
Incidence of skin sensitisation is low.
Executive summary:

Among the 23192 patients patch tested from 1950 to 1962, positive reactions to cellulose acetate film containing 7 to 10% triphenyl phosphate and 3 to 4% phthalic esters occured in 15 (0.065%). The sensitivity to cellulose acetate film was analysed in only two cases, in both of which the sensitiser was found to be triphenyl phosphate. In the others it may have been either triphenyl phosphate or phthalic ester.