5H-Cyclopenta[h]quinazoline, 6,6a,7,8,9,9a-hexahydro-7,7,8,9,9-pentamethyl-

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

The study was conducted between 20 December 2013 and 7 February 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

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:

No guideline available. The study was performed according to Api, 2002, Sensitisation methodology and primary prevention of the Research Institute for Fragrance Materials, Dermatology, 205, 84-87.

GLP compliance:

yes

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 104
- Sex: both male and female
- Age: between 18 and 70
- Race: not specified
- Other: all subjects signed an Informed Consent Form in compliance with 21 CFR Part 50: ''Protection of Human Subjects'' and a HIPAA Authorization Form in compliance with 45 CFR Parts 160 and 164. All subjects completed a Subject Profile/Medical History Form provided by Clinical Research Laboratories, Inc. prior to the study.

Clinical history:

- Subjects completed a Panelist Profile/Medical History and were in general good health as determined by the Panelist Profile/Medical History.
- Subjects did not report a history of acute or chronic dermatologic, medical or physical conditions that could interfere with dermal scoring.

Controls:

No

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: repeated insult patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: 3.63 cm^2 patch, no further details provided
- Vehicle / solvent: Alcohol SD3A:DEP (25:75)
- Concentrations: 5%
- Volume applied: 0.2 mL
- Testing/scoring schedule: patches were applied to the skin with direct skin contact for 24 hours. Patches were applied to the same site on Monday, Wednesday and Friday for a total of 9 applications. Scoring was done 24 hours after removal of the patches by the subjects on Tuesday and Thursday and 48 hours after removal of the patches on Saturday.
The testing and scoring schedule may have been modified based on availability of the subjects.
- Removal of test substance: not specified

Challenge phase: following a 2-week rest period, the challenge patches were applied to previously untreated test site on the back. After 24 hours, the patches were removed and the test sites were evaluated for dermal reactions. The test sites were re-evaluated at 48 and 72 hours.

EXAMINATIONS
- Scoring system: see 'Any other information on materials and methods incl. tables'

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: no irritation or sensitization was observed.

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

Applicant's summary and conclusion

Conclusions:

Application of 0.2 mL with 5% test substance applied at 3.63 cm^2 was not sensitising under the conditions of the test in 104 subjects.

Executive summary:

The induction phase took place on Monday, Wednesday and Friday till 9 applications had been made in approximately 3 weeks. The amount of volume applied was 0.2 ml, test concentration used was 5% and the applied surface was 3.63 cm^2.

During the induction patches were placed at the upper side of the back. Technicians removed the patches 24 hours after application, except for Saturdays on which the patients removed the patches themselves. After removal, 24 hours the skin was not treated, except for the 48 hours treatment free period after the Friday application. Two weeks after the final induction treatment, a challenge patch was applied to untreated sites of the back and removed after 24 hours. Reactions to the challenge were assessed after 24, 48, 72 and 96 hours. None of the 104 subjects tested was sensitised by the sample. It was therefore concluded that the test substance is not sensitising at the concentration used.