Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Not reported

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Human repeated insult patch test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 50 subjects;
- Sex: 29 males; 21 females
- Age: Males: 22-48 years (Caucasian); 28 year (negro); 23-34 years (oriental) /females: 19-52 years (Caucasian); 30 year (oriental)
Clinical history:
None
Controls:
White Petrolatum
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: oval-shabed adhesive patches (1" x 1-1/4") with curcular gauze centers
- Vehicle / solvent: White petrolatum
- Concentrations: 2% in White Petrolatum
- Volume applied: Approximately 0.3 mL
- Testing schedule:
Phase I (Induction phase): Total of 9 induction applications
Phase III (challenge phase): 2 weeks after the last induction, on a new skin site, for 24-hr

EXAMINATIONS
Grading/Scoring system: Scoring Criteria for Skin Irritation Reactions

- Erythema and Eschar Formation:
No reaction: 0
Very slight erythema (barely perceptible): 1
Mild, well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4

- Oedema Formation:
No reaction: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edge of area well-defined by definite raising): 2
Moderate oedema (area raised approximately 1 mm): 3
Severe oedema (area raised more than 1 mm and extending beyond area of exposure): 4

- Statistical analysis: None

Results and discussion

Results of examinations:
SYMPTOMS
None

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 50
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

Applicant's summary and conclusion

Conclusions:
Under the condition of the study, the test material is not a skin sensitizer at 2% in White Petrolatum.
Executive summary:

A panel of 50 male and female human volunteers participated in a repeat insult patch test in which a 2% in White Petrolatum of the test material was applied under occlusive patches. During the induction phase nine patches were applied. Two weeks after the last induction application, a challenge patch was applied and the sites scored 24 h (after removal of patch).

 

Under the conditions employed in this study, there was no evidence of sensitisation to the test material.