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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2008-01-14 to 2008-02-25
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:
2008
Report date:
2008

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
according to guideline
Guideline:
other: Repeated Insult Patch Test, Protocol No.: 1.01
Deviations:
no
GLP compliance:
yes
Remarks:
The test was performed in compliance with the ICH Guideline E6 for Good Clinical Practice (GCP), as a human study was conducted.

Test material

Constituent 1
Chemical structure
Reference substance name:
3-methyl-5-phenylpent-2-enenitrile
EC Number:
299-682-2
EC Name:
3-methyl-5-phenylpent-2-enenitrile
Cas Number:
93893-89-1
Molecular formula:
C12 H13 N
IUPAC Name:
(2E)-3-methyl-5-phenylpent-2-enenitrile

Method

Type of population:
general
Ethical approval:
not applicable
Subjects:
- Number of subjects exposed: 110
- Sex: male and female
- Age: 16-79
Clinical history:
- History of allergy or casuistics for study subject or populations: only healthy subjects without known skin diseases participated
Controls:
not required
Route of administration:
dermal
Details on study design:
TYPE OF TEST USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: adhesive dressing manufactured by TruMed Technologies, Inc., Burnsville, MN
- Vehicle / solvent: DEP/EtOH
- Concentrations: 0.5 %
- Volume applied: appr. 0.2 mL
- Testing/scoring schedule: The induction patch was applied on Janura 14, 2008; the challenge phase started approcimatles two weeks afterwards.


EXAMINATIONS
- Grading/Scoring system: erythema and additional dermal sequelae were scored according to a 5 graded scoring scale

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: During induction phase, moderate skin reactions (erythema and edema) were observed after the 7th induction application. In one additional subject, barely perceptible skin reactions were observed after the induction applications 7, 8 and 9. No skin reactions were observed after the challenge exposure.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 1

Applicant's summary and conclusion

Conclusions:
The test material at a concentration of 0.5 % did not indicate a potential for skin sensitization.
Executive summary:

110 male and female volunteers participated in a study to assess the potential of the test material at a concentration of 0.5 % (in DEP/ethanol) to induce skin sensitization after repeated epidermal contact. The subjects were instructed to apply the test material to a treatment area on their upper backs. Patches were applied three times per week for a total of nine inductions (induction phase). Approximately two weeks after the final induction patch application, a challenge patch was applied to a new test site. This patch was removed and the test site scored after 24 and 72 hours. As a result, during induction phase, moderate skin reactions (erythema and edema) were observed after the 7th induction application. In one additional subject, barely perceptible skin reactions were observed after the induction applications 7, 8 and 9. No skin reactions were observed after the challenge exposure. Therefore it was concluded that the test material at a concentration of 0.5 % did not cause skin sensitization.