5H-Cyclopenta[h]quinazoline, 6,7,8,9-tetrahydro-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:

11 Sep 2013 to 18 Oct 2013

Reliability:

2 (reliable with restrictions)

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:

2013

Report date:

2013

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

- Principle of test: Repeated Insult (occlusive)
- Short description of test conditions: During the induction phase 0.2 mL of 10% of the substance was placed to the back of each subject, every Monday, Wednesday and Friday till 9 applications had been made. The patch was removed after 24 hours. During the challenge phase (after a rest period of 2 weeks) the challenge patch was applied to a previously unpatched test site.
- Parameters analysed / observed: During the induction phase positive reactions of a level 2 erythema or greater results in a change of application site After the challenge, the site was scored after 24, 48 and 72 hours for erythema and oedema

GLP compliance:

yes

Remarks:

Good Clinical Practice Quality Assurance Audit Statement

Test material

Test material information

1

Reference substance name:

(8S)-7,7,8,9,9-pentamethyl-5H,6H,7H,8H,9H-cyclopenta[h]quinazoline

EC Number:

801-093-8

Cas Number:

1315251-11-6

Molecular formula:

C16H22N2

IUPAC Name:

(8S)-7,7,8,9,9-pentamethyl-5H,6H,7H,8H,9H-cyclopenta[h]quinazoline

Test material form:

solid

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 112
- Sex: Male and female
- Age: 18 - 70 years

Clinical history:

The subjects did no exhibit any physical or dermatological condition that would have precluded application of the test article or determination of potential effects of the substance

Route of administration:

dermal

Details on study design:

TYPE OF TEST USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: Occlusive
- Description of patch: 3.63cm^2 patch.
- Concentrations: 10% w/w EtOH:DEP (1:3))
- Volume applied: 0.2 mL

EXAMINATIONS
- Grading/Scoring system: See 1 table in ''Any other information on materials and methods incl. tables''

Results and discussion

Results of examinations:

- At 10%, the test material did not demonstrate a potential for eliciting dermal irritation or sensitisation.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions 107
- Number of subjects discontinued study participation: 5

Applicant's summary and conclusion

Conclusions:

Based on the test population of 107 subjects and under the conditions of this study, the substance (10% w/w EtOH:DEP(1 :3) did not demonstrate a potential for eliciting dermal irritation or sensitisation

Executive summary:

112 subjects participated in evaluating the potential of the substance to elicit dermal irritation and/or induce sensitisation. The substance was applied under an occlusive patch to the upper back of each subject and was allowed to remain in direct skin contact for a period of 24 hours. Patches were applied to the same site on Monday, Wednesday, and Friday for a total of 9 applications during the Induction Period. The sites were graded by a CRL technician for dermal irritation 24 hours after removal of the patches by the subjects on Tuesday and Thursday and 48 hours after removal of the patches on Saturday. Following approximately a 2-week rest period, challenge patches were applied to previously untreated test sites on the back. After 24 hours, the patches were removed by a CRL technician and the test sites were evaluated for dermal reactions. The test sites were re-evaluated at 48 and 72 hours. Subjects exhibiting reactions during the Challenge Phase of the study may have been asked to return for a 96-hour reading. 107 subjects completed the study. 

The substance (10% w/w EtOH:DEP(1:3) did not demonstrate a potential for eliciting dermal irritation or sensitisation under the following test conditions: 0.2 mL of the substance applied to a 3.63 cm^2 occlusive patch.