Bis(2-ethylhexyl) 2-(4-hydroxy-3,5-dimethoxybenzylidene)malonate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2005-08-15 to 2005-09-23

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:

2005

Report date:

2005

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

according to guideline

Guideline:

other: proDERM Standard Protocol-V05

Version / remarks:

V05

Deviations:

no

GLP compliance:

no

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

liquid: viscous

Details on test material:

Chemical name: 2-(4-Hydroxy-3,5-dimethoxy-benzylidene)-malonic acid bis-(2-ethyl-hexyl) ester
CAS No.: 444811-29-4

Method

Type of population:

general

Ethical approval:

no

Remarks:

not needed for cosmetic formulation

Subjects:

- Number of subjects exposed: 215
- Sex: 51 male, 164 female
- Age: 46.2 +/- 12.9 years

Clinical history:

no information

Controls:

The vehicle (vaseline) without test item was used as a control for irritation in each volunteer

Route of administration:

dermal

Details on study design:

TYPE OF TEST USED: Human Repeat Insult Patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: Hilltop Chambers, large
- Vehicle / solvent: Vaseline
- Concentrations: 5%
- Volume applied: 200 µL
- Testing/scoring schedule:
Induction Phase (3 weeks): Application 3 times per week, each patch applied for 48 hours (total number of applications: 9)
Resting phase (2 weeks)
Challenge phase (1 week): single application for 48 hours (total number of application: 1)


EXAMINATIONS
- Grading/Scoring system (Erythema):
0: No evidence of irritation
0.5: Equivocal reaction (minimal erythema, barely perceptible)
1: Definite erythema
2: Erythema, minimal edema, and/or minimal papules
3: Erythema, induration (edema), and papules
4: Erythema, induration (edema), and vesicles
5: Strong reaction, clearly spreading beyond test site

Results and discussion

Results of examinations:

The 215 volunteers have been investigated for erythema/edema at different time points during induction phase and once during the challenge phase. During induction, some volunteers showed erythema at score levels of 0.5 and 1. One volunteer showed a score of 2.
During challenge, no volunteer exhibited a score of 2 or greater. Moreover, the proportion of volunteers showing 0.5 and 1 scores was comparable to those of the induction phase.

Any other information on results incl. tables

tables see attached background material

Applicant's summary and conclusion

Conclusions:

Under the exposure conditions applied in this study, the test item did not indicate a potential for cumulative skin irritation.
During the challenge phase, the test item did not indicate a potential for producing a delayed contact hypersensitivity.

Executive summary:

The test item was investigated for its skin sensitizing potential in a Human Repeat Insult Patch Test (HRIPT) in 215 volunteers (male and female). The test material was applied as a 5% formulation in vaseline under occlusive conditions (Hill chamber). During induction, formulations with the test item were applied to each volunteer 3 times per week for 3 weeks. After a rest period of 2 weeks, the test formulation with 5% test item was applied once for 48 hours. No increase in the overall score (number and grade) was observed during challenge. Under the exposure conditions applied in this study, the test item did not indicate a potential for cumulative skin irritation.

During the challenge phase, the test item did not indicate a potential for producing a delayed contact hypersensitivity.