Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Study period:
report date 20th September 2019
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: own data
Title:
Unnamed
Year:
2020
Report date:
2020

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
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)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
50 % aq. solution

Method

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 and discussion

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.

Applicant's summary and conclusion

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.