(4R)-Tetrahydro-4-hydroxy-4-methyl-2H-Pyran-2-one

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation, other

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

20th September 2019

Reliability:

1 (reliable without restriction)

Cross-reference

Reason / purpose for cross-reference:

exposure-related information

Reference

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Study period:

report date 20th September 2019

Reliability:

1 (reliable without restriction)

Type of sensitisation studied:

skin

Study type:

study with volunteers

Qualifier:

according to guideline

Guideline:

other: dermatalogocical assesement of safe use of mevalonlactone with volunteers (claim "dermatologically tested" is approved)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

50 % aq. solution

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

Female and male, aged from 19 to 60 years (mean age 43)

Clinical history:

Healthy subjects
intact skin on test site
ability of giving a consent for his/her participation
aged from 18 to 70 years
Phototype (Fitzpatrick): i to IV
any gender

non-inclusion criteria:
pregnancy or breastfeeding
skin marks on test sites (pigmentation disorders, vascular malformations, scars, sunburns)
active dermatosis
Antecedents of allergic reactions
Atopy antecedents
Discomfort sensation with temperature changes
Subjects with history of allergy to the materials used in the study
[...]

Controls:

yes.

Route of administration:

dermal

Details on study design:

evaluation scale used was published by the International Contact Dermatitis Research Group (ICDRG), (FISCHER, 1995)
Induction period with 9 consecutive applications lasting 3 weeks
2 Weeks resting period
6th week: Challenge Period with one application

Results of examinations:

During the study, no subjects presented any clinical sign in the test product application site. No subjects presented clinical signs in the control site.

Conclusions:

According to the methodology used to assess the absence of the skin sensitization potential of the product Mevalonolactone, it could be concluded that:

During the study, no subjects presented skin clinical signs related to the product.
The product did not induced a skin sensitization process in the study group.
The product was considered safe under the study conditions.
The claim "Dermatologically tested" can be supported.

Materials and methods

In vivo test system

Test animals

Strain:

not specified