Registration Dossier

Diss Factsheets

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: Acceptable, well documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Eighty subjects received occlusive plasters containing test preparations, on one arm, three times weekly for three weeks. After an interval of two weeks, single applications were made to both arms, followed by inspection at 48 and 96 hours.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Polypropylene containing 0.5 or 5% of CAS 63843-89-0
IUPAC Name:
Polypropylene containing 0.5 or 5% of CAS 63843-89-0
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Physical state: fine white powder
- Analytical purity: no data provided

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 80
- Sex: 4 males and 76 females
- Age: from 21 to 78
Controls:
only vehicle
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: patch strip consisting of four 22 mm diameter circular undressed lint (Webril, Curity) pads located along the centre of 50 mm wide adhesive tape (Blenderm, 3M Company)
- Vehicle / solvent: Carboxymethylcellulose in water
- Concentrations: 40% w/v or 50% w/v suspensions in 3% w/v carboxymethylcellulose in water
- Volume applied: 0.5 mL
- Testing/scoring schedule: Patches were applied on Monday, Wednesday and Friday of the three-week induction (insult) period. Patches were re-applied to the same site unless reaction to a test substance or to the plaster adhesive necessitated a move, in which case an adjacent location was chosen. Subjects who were absent once during the insult period received a make-up patch (MU) on the fourth Monday.
Fourteen days after the final induction patch (i.e. five weeks after the initial patch) applications were made to both arms of each subject. The sites were designated original (Or.) or alternate (Alt.) and the results were graded after 48 and 96 hours.
- Removal of test substance: after 24 hours
- Other: The patch strip was applied to the dorsal surface of the upper arm of each subject, the position being marked by three spots of methyl, violet stain.

EXAMINATIONS
- Grading/Scoring system: scoring after 24 hours after patch removal
Patch Scoring System:
0 - No visible reaction
1 - Mild reaction, erythema
1E - Mild erythematous reaction with papules and/or oedema
2 - Moderate reaction, erythema (a grade of 2 or higher during induction necessitates relocation of the patch)
2E - Moderate erythematous reaction with oedema and/or papules
3 - Strong reaction, erythema
3E - Strong eryrthematous reaction with marked oedema, papules and/or vesicles
4 - Severe reaction with erythema, oedema, papules and vesicles (may be evidence of weeping)
A - Marked reaction to adhesive (patch relocated)
L - Patch came off (lost) during first 12 hours
(-) - Subject absent
NP - In summary tables: total number not patched because of absence.

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: No evidence of sensitization was seen. The incidence of erythema, while low, appeared to be dose-related.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION

Polymer without substance: numbers of reactions to 40% suspension in 3% carboxymethylcellulose
- Number of subjects with positive reactions: 2 after 48 hours; 1 after 96 hours (erythema score 1)
- Number of subjects with negative reactions: 78 after 48 hours; 79 after 96 hours

Polymer with 0.5% tet substance: numbers of reactions to 50% suspension in 3% carboxymethylcellulose
- Number of subjects with positive reactions: 10 after 48 hours; 3 after 96 hours (erythema score 1)
- Number of subjects with negative reactions: 70 after 48 hours; 77 after 96 hours

Polymer with 5% test substance: numbers of reactions to 50% suspension in 3% carboxymethylcellulose
- Number of subjects with positive reactions: 14 (13 x erythema score 1 and 1x erythema score 1E) after 48 hours; 4 after 96 hours (erythema score 1)
- Number of subjects with negative reactions: 66 after 48 hours; 76 after 96 hours

Applicant's summary and conclusion