2-Propenoic acid, 2-cyano-3-(4-methoxyphenyl)-3-phenyl-, 2-ethylhexyl ester

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

12 September 2007 to 18 October 2007

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

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:

The substance was applied to the human skin to identify primary or cumulative irritation and/or allergic contact sensitisation. The study consists of 2 phases; induction phase with 9 applications for 24 hours and the challenge phase with a single application for 24/72 hours.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl (2E)-2-cyano-3-(4-methoxyphenyl)-3-phenylprop-2-enoate; 2-ethylhexyl (2Z)-2-cyano-3-(4-methoxyphenyl)-3-phenylprop-2-enoate

EC Number:

700-213-5

Cas Number:

947753-66-4

Molecular formula:

C25H29N03

IUPAC Name:

2-ethylhexyl (2E)-2-cyano-3-(4-methoxyphenyl)-3-phenylprop-2-enoate; 2-ethylhexyl (2Z)-2-cyano-3-(4-methoxyphenyl)-3-phenylprop-2-enoate

Details on test material:

- Name of test material (as cited in study report): RX14180
- Lot/batch No.: LOT#ABP4-071907

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 56.
- Sex: Male/female.
- Age: From 16 to 76 years old.

Clinical history:

- Medical history (for respiratory hypersensitivity): People without any illness, doctor's care, medications, adverse reactions to cosmetics or other personal care products or visible skin disease.
- Other: Participants were prohibited to use topical or systematic steroids and/or antihistamines for at least 7 days prior to the study initiation. Pregnant women were excluded.

Controls:

No.

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test.

ADMINISTRATION
- Type of application: occlusive.
- Vehicle / solvent: Corn oil.
- Concentrations: 20% dilution in the vehicle.
- Volume applied: Approximately 0.2 ml.
- Testing/scoring schedule: Induction phase with 9 applications for 24 hours and the challenge phase with a single application for 24/72 hours. Two weeks interval between induction phase and challenge phase.
- Removal of test substance: 24 hours after the application in induction phase, 24/72 hours in challenge phase.

EXAMINATIONS
- Grading/Scoring system: Arbitrary scheme 9erythema and additional dermal sequelae).

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: No sysmptoms observed.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0.
- Number of subjects with negative reactions: 50 (6 subjects incompleted the study).
- Number of subjects with irritating reactions: 0.

Applicant's summary and conclusion

Conclusions:

Under the conditions of the study, the test material did not indicate a potential for dermal irritation or allergic contact sensitisation.

Executive summary:

The test substance was applied to the human skin to identify primary or cumulative irritation and/or allergic contact sensitisation. Fifty-six males/females participated in the study. No test guideline was dollowed. T

he study consists of 2 phases; induction phase with 9 applications for 24 hours and the challenge phase with a single application for 24/72 hours with 2 weeks of interval between the phases. No potential irritation or sensitisation have been observed under the test condition.