2-pentylcyclopentan-1-one

Sensitisation data (human)

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

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

Test material information

Constituent 1

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.