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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
From October 16 to November 28, 1978
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Draize-Shelanski (Modified) method
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-pentylcyclopentan-1-one
EC Number:
225-392-2
EC Name:
2-pentylcyclopentan-1-one
Cas Number:
4819-67-4
Molecular formula:
C10H18O
IUPAC Name:
2-pentylcyclopentan-1-one
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): P1078/2 @ 10.0% in White Petrolatum

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed: 50 subjects
- Sex: 35 females; 15 males
- Age: 16-60 years
Clinical history:
None
Controls:
P1078/10 White Petrolatum (Control)
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: Patch test (epicutaneous test)

ADMINISTRATION - RIPT
- No. of subjects: 50
- Type of application: Occlusive
- Application site: Arms or forearms
- Description of patch: Test material was applied directly to the skin with the aid of lintine disks, secured and made air-tight with Dermicel tape.
- Vehicle / solvent: White petrolatum
- Concentrations: 10 % in white petrolatum
- Volume applied: Approximately 0.5 g
- Testing schedule: During the induction phase ten patches were applied, separated by a 24 h interval. After 10-14 days rest period, challenge or retest dose was applied for a 24 h period.
- Scoring schedule: 24 h after application
- Removal of patch: 24 h after application

ADMINISTRATION - Photosensitization study
- No. of subjects: 25
- Vehicle / solvent: White petrolatum
- Concentration: 10 %
- Irradiation: Following the evaluation of the sensitization patch, the test site area of twenty-five subjects were exposed to a Hanovia UV sunlamp for a period of 45 seconds at a distance of 20 inches.
- Scoring schedule: 24 h after UV exposure

EXAMINATIONS
Grading/Scoring system: Scoring Criteria for Skin Irritation Reactions
- Erythema and Eschar Formation:
No reaction: 0
Very slight erythema (barely perceptible): 1
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 (raised more than 1 mm and extending beyond area of exposure): 4

- Statistical analysis: None

Results and discussion

Results of examinations:
SYMPTOMS
- Test material did not produce primary irritation, fatiguing or sensitization reactions in any of the subjects.

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

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
The test material does not appear to be a primary skin irritant or fatiguing agent. No sensitization reactions were noted. Exposure to UV light does not appear to initiate or increase the incidence and severity of irritation, fatigue or sensitization.
Executive summary:

A panel of 50 male and female human volunteers participated in a repeat insult patch test in which the test material was applied to the arms or fore arms of the subjects under occlusive patches. During the induction phase ten patches were applied, separated by a 24 h interval. The patches were removed 24 hours after application. Following a 10-14-day rest period, a challenge patch was applied for 24 h and the sites scored 24 h after application.

A subset of 25 subjects selected from the group of 50 subjects was simultaneously studied for photosensitization. Following the evaluation of the sensitization patch, the test site area of twenty-five subjects were exposed to a UV light for a period of 45 seconds at a distance of 20 inches.

24 h later these areas were examined for phototoxic response.

The test material does not appear to be a primary skin irritant or fatiguing agent. No sensitization reactions were noted. Exposure to UV light does not appear to initiate or increase the incidence and severity of irritation, fatigue or sensitization.

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