reaction mass of diethyl (E)-2-methylbut-2-enedioate and diethyl (Z)-2-methylbut-2-enedioate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

14 August 2017 - 22 September 2017

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:

2017

Report date:

2017

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

according to guideline

Guideline:

other:

Version / remarks:

internal approved standard method

Deviations:

no

GLP compliance:

no

Remarks:

but GCP compliance (according to ICH Guideline E6)

Test material

Test material information

Constituent 1

Reference substance name:

diethyl 2-methylidenebutanedioate

EC Number:

607-321-0

Cas Number:

2409-52-1

Molecular formula:

C9H14O4

IUPAC Name:

diethyl 2-methylidenebutanedioate

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 105 subjects completed the study
- Sex: male/female
- Age: 18-78 years

Clinical history:

Exclusion Criteria:
- Ill health
- Under a doctor's care or taking medications which could influence the outcome of the study
- Pregnancy or nursing
- A history of adverse reactions to cosmetics or other personal care products

Route of administration:

dermal

Details on study design:

TYPE OF TEST USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: absorbent pad + adhesive dressing
- Concentrations: 1.1%
- Volume applied: 0.2 mL
- Testing/scoring schedule: Patches were applied three times per week (e.g., Monday, Wednesday, and Friday) for a total of nine applications. Challenge exposure two weeks after the final Induction patch application.
- Removal of test substance: twenty-four hours after application

EXAMINATIONS
- Grading/Scoring system: 0 = No visible skin reaction, 0.5 = Barely perceptible, 1 = Mild, 2 = Moderate, 3 = Marked, 4 = Severe, E = Edema, D = Dryness, S = Staining, P = Papules, V = Vesicles, B = Bullae, U = Ulceration, Sp = Spreading

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: no symptoms observed

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 105
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, test material (1.1%), indicated no potential for dermal irritation or allergic contact sensitisation.

Executive summary:

A human repeated insult patch test was performed to determine the potential of a test material to induce primary or cumulative irritation and/or allergic contact sensitization. One hundred 115 qualified subjects, male and female, were selected for this evaluation. 105 subjects completed the study. The remaining subjects discontinued their participation for various reasons, none of which were related to the application of the test material.

The upper back between the scapulae served as the treatment area. Approximately 0.2 mL of the test material, or an amount sufficient to cover the contact surface, was applied to the 3/4" x 3/4" absorbent pad portion of an adhesive dressing. This was then applied to the appropriate treatment site to form an occlusive patch. For induction patches were applied three times per week for a total of applications. The induction patches were removed twenty-four hours after application and the erythema were scored. Approximately two weeks after the final Induction patch application, a challenge patch was applied to a virgin test site adjacent to the original Induction patch site, following the same procedure described for induction. The patch was removed and the site scored at the clinic Day 1 and Day 3 post-application.

Observations remained within normal limits throughout the test interval. Under the conditions of this study, test material (1.1%) indicated no potential for dermal irritation or allergic contact sensitisation.