Reaction mass of Benzenepropanal, 4-ethyl-α,α-dimethyl- and 3-(2-ethylphenyl)-2,2-dimethylpropanal

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

7 Nov 2011 to 16 Dec 2011

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

A repeated insult patch study was conducted to determine if the test material would induce contact sensitization in humans. A modified Draize procedure was used following Shelanski, 1953 (Proc.Sci.Sect. Toilet Goods Assoc. 19:46,1953)

GLP compliance:

no

Remarks:

but it was according to Good Clinical Practice (GCP)

Test material

Test material information

Test material form:

liquid

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 112 started the program, of which 108 subjects completed the study
- Sex: male and female
- Age: between 18 and 70
- Females were not pregnant or lactating
- Subjects agreed to avoid exposure of the test sites to the sun and to refrain from visits to tanning salons during the course of the study

Clinical history:

- Subjects were in general good health
- Subjects had no visible or known pre-existing skin diseases that might be confused with a skin reaction of the test material, or which may be reasonably expected to affect the outcome of the study
- Subjects did not have a history of acute or chronic dermatologic, medical, or physical conditions that could interfere with dermal scoring- Subjects were not currently using any systemic or topical corticosteroids, anti-inflammatory drugs or anthistamines
- Subjects did not exhibit skin disorder, sunburn, scars, excessive tattoos, etc. in the test area

Route of administration:

dermal

Details on study design:

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

ADMINISTRATION
- Type of application: occlusive
- Description of patch: occlusive strip with Flexcon ® (TruMed Technologies Inc., Burnsville, Minnesota)
- Vehicle / solvent: EtOH:DEP (1:3)
- Concentrations: 3.5%
- Volume applied: 0.2 mL
- Testing/scoring schedule: Prior to application of the test patch, the test area was wiped with 70% isopropyl alcohol and allowed the dry. The test material was applied to a 3.63 cm2 patch and allowed to evaporate for at least 30 minutes, but no longer than 90 minutes, prior to patch application. It was applied to the upper back (between the scapulae) and 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. This schedule may have been modified to allow for missed visits or holidays. If a subject was unable to report on an assigned test date, the test material was applied on 2 consecutive days during the Induction Phase and/or a makeup day was added at the end of the Induction Phase. The sites were graded for dermal irritation 24 hours after removal of the patches on Tuesday and Thursday and 48 hours after removal of the patches on Saturday. If a “2+” reaction or greater occurred, the test material was applied to an adjacent virgin site. If a “2+” reaction or greater occurred at the new site, the subject was not patched again during the Induction Phase but was challenged on the appropriate day of the study.
Following approximately a 2-week rest period, the challenge patches were applied to the 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.
- Removal of test substance: Only total patch removal

EXAMINATIONS
- Grading/Scoring system: 0 = no visible skin reaction, ± = barely perceptible erythema, 1+ = mild erythema, 2+ = well defined erythema, 3+ = severe erythema and edema, 4+ = erythema and edema with vesiculation

Results and discussion

Results of examinations:

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 108
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

Applicant's summary and conclusion

Conclusions:

Under the conditions of the test 3.5% test substance was not sensitising.

Executive summary:

One hundred twelve subjects participated in evaluating the potential of 3.5% w/w test material in EtOH:DEP (1:3) to elicit dermal irritation and/or induce sensitization. The test material 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 for a total of 9 applications during the Induction Period. The sites were graded for dermal irritation 24 hours after removal of the patches and 48 hours after removal. Following a 2-week rest period, challenge patches were applied to previously untreated test sites on the back. After 24 hours, the patches were removed and evaluated. The test sites were re-evaluated at 48 and 72 hours. One hundred eight subjects completed the study. The test material did not demonstrate a potential for elicit dermal irritation or sensitization under the test conditions.