2,2,5-trimethyl-5-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 November 14 to December 16, 1977

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:

Repeated insult patch test or Draize-Shelanski test

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2,5-trimethyl-5-pentylcyclopentan-1-one

EC Number:

265-779-3

EC Name:

2,2,5-trimethyl-5-pentylcyclopentan-1-one

Cas Number:

65443-14-3

Molecular formula:

C13H24O

IUPAC Name:

2,2,5-trimethyl-5-pentylcyclopentan-1-one

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Samples of 0977/1 10% in White Petrolatum

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 52 subjects; 50 subjects completed the study
- Sex: 25 males; 27 females
- Age: Males: 23-43 years (Caucasian); females: 20-49 years (Caucasian); 24-34 years (Negro)

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
- Site of application: Upper back, scapular area for induction. Challenge patch was placed adjacent to but not in contact with the site of the induction applications.
- Description of patch: Readi-Band clear plastic patches, which are approximately 1 ½” square and contain a ¾” square nonwoven Webril centre were utilized for all patch applications.
- Vehicle / solvent: White petrolatum
- Concentrations: 0977/1 10% in White Petrolatum
- Volume applied: Approximately 0.2 mL
- Testing schedule:
Phase I (Induction phase): Total of 9 induction applications within a period of 3 consecutive weeks.
Phase II: During this phase, exposure to the test material was terminated for a period of 12 days following the last induction application (Thursday, Week 3)
Phase III (challenge phase): On the twelfth day following the last induction application, all panellists were exposed to a single, occluded patch application of the test material as in Phase I.
- Exposure period: 23 h
- Scoring schedule: Induction: skin sites were graded for irritation approximately 30-60 minutes following patch removal; challenge: Approximately 30-60 minutes following removal of the challenge patch, both the challenge site and site of the induction applications were graded for irritation. Both these sites were again observed for possible delayed reactions (indicative of sensitization) 48 and 72 hours after application of the challenge patch.
- Removal of patch: 23 h after application

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
- 0977/1 10% in White Petrolatum: Two subjects exhibited slight irritation reactions at random intervals during the course of the induction applications. These reactions were transient in nature and may be considered of little or no consequence based on the total response of the panel to the test product.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
0977/1 10% in White Petrolatum:
- 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: 2

Any other information on results incl. tables

Table 7.10.4/1: Skin reactions

Test material	No. of Reactors	No. of Reactions	No. of patches applied	Reactions with scores
				0	1	2	3	4	5	6	7	8
0977/1 10% in White Petrolatum	2	2	457	455	2	0	0	0	0	0	0	0

 

1-2-slight; 3-4=mild; 5-6=moderate; 7-8=severe

See the attached document for information on tables of results

Applicant's summary and conclusion

Conclusions:

Under the condition of the study, the test material is not a skin sensitizer at 10% in White Petrolatum.

Executive summary:

A panel of 52 male and female human volunteers (50 subjects completed the study) participated in a repeat insult patch test in which a 10% in White Petrolatum of the test material was applied to the upper back, scapular area of the subjects under occlusive patches. During the induction phase nine patches were applied within a period of 3 consecutive weeks. The patches were removed 23 hours after application. On the twelfth day following the last induction application, a challenge patch was applied and the sites scored 24 h (30-60 minutes after removal of patch), 48 and 72 h after application.

At 10% in White Petrolatum, two subjects exhibited slight irritation reactions at random intervals during the course of the induction applications. These reactions were transient in nature and may be considered of little or no consequence based on the total response of the panel to the test product. There was no evidence of sensitization to either material noted at any time in any of the subjects participating in the study.

 

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