Cocoa, powd., alkalized

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion

Remarks:

other: Ex vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: No information on GLP status.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2008

Materials and methods

Test guideline

Qualifier:

no guideline available

Deviations:

not applicable

Principles of method if other than guideline:

Human skin explants (obtained from Caucasion women aged 39-68 years – 3 donors) were exposed topically in culture to 1.5% of the test substance blended with cocoa butter or with cocoa butter alone on days 0, 1, 2, 5, 7 and 9, with sampling on days 5 and 12.(preliminary experiment). Second experiment to determine effective dose: cocoa polyphenol/cocoa butter blend with cocoa polyphenol concentrations of 0.125%, 0.25%, 0.50%. 0.75%, and 1.0%, dosed on days 0, 1, 2, 4, 6, 8, and 10, with sampling on days 6 and 11. The explants were processed histologically. By immunostaining (antibodies with a biotin/streptavidin enhancement system) collagen type I, III, and IV as well as glycosaminoglycan were tagged. Intensity and area of the staining were recorded by image analysis.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Polyphenolic fraction of cocoa powder commercially available at Barry Callebaut, Zurich, Switzerland under trade name “Acticoa”. 45% polyphenol content, 5.17% epicatechin, 0.75% catechin

IUPAC Name:

Polyphenolic fraction of cocoa powder commercially available at Barry Callebaut, Zurich, Switzerland under trade name “Acticoa”. 45% polyphenol content, 5.17% epicatechin, 0.75% catechin

Test material form:

solid: compact

Details on test material:

Name of test material (as cited in study report): Acticoa (cocoa polyphenol extract).

- Molecular formula (if other than submission substance): Not applicable
- Molecular weight (if other than submission substance): Not applicable
- Smiles notation (if other than submission substance): Not applicable
- InChl (if other than submission substance): Not applicable
- Structural formula attached as image file (if other than submission substance): Not applicable
- Substance type:
- Physical state: solid
- Analytical purity: Not applicable
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: see Identity
- Isomers composition: Not applicable
- Purity test date: Not applicable
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals

Species:

other: Human, Female, Caucasian donors of the skin explants

Test system

Type of coverage:

open

Vehicle:

other: Cocoa butter

Controls:

other: Yes: untreated, carrier (cocoa butter) only,

Amount / concentration applied:

2mg/day, 0.50 and 0.75% in cocoa butter

Duration of treatment / exposure:

10days

Observation period:

12 days (preliminary study), 11 days (dose effect study)

Number of animals:

3 explants per dose group

Results and discussion

In vivo

Irritant / corrosive response data:

Results

GAGs Collagen I Collagen III Collagen IV
Mean SD Mean SD Mean SD Mean SD

Untreated control 15.5 6.7 20.7 8.0 31.7 13.8 20.1 6.4
CPP (0.75%) 46.3 8.2 41.2 10.4 38.9 5.3 29.5 7.6
CPP (0.50%) 38.1 2.9 28.4 9.5 50.9 7.8 32.0 4.1
Estee Lauder* 47.5 5.2 17.0 2.5 54.3 11.3 42.2 10.4

CPP = cocoa polyphenols
GAGs = Glycosaminoglycans
(* Commercial “anti-aging” skin care product)

Any other information on results incl. tables

Results

 

                                  GAGs              Collagen I               Collagen III              Collagen IV

                                  Mean SD         Mean  SD              Mean  SD               Mean  SD  

 

Untreated control    15.5   6.7         20.7    8.0              31.7   13.8             20.1     6.4

CPP (0.75%)           46.3   8.2         41.2  10.4              38.9     5.3             29.5    7.6

CPP (0.50%)           38.1   2.9         28.4    9.5              50.9     7.8             32.0    4.1

Estee Lauder*          47.5   5.2         17.0    2.5              54.3   11.3            42.2  10.4

 

CPP = cocoa polyphenols

GAGs = Glycosaminoglycans

(* Commercial “anti-aging” skin care product)

Applicant's summary and conclusion

Interpretation of results:

other: In the preliminary qualitative study, small increases in epidermal thickness and collagen density were observed after 5 days of treatement. After 12 days, marked increases were seen in all collagen types; GAGs were also increased slightly.

Remarks:

Criteria used for interpretation of results: expert judgment

Conclusions:

The polyphenolic fraction of cocoa powder induces an increase in glycosamines and collagens. These are skin components that are indicative for skin elasticity and tonus. No negative influences on the skin explants were observed, in fact, the cocoa polyphenols exhibited a positive effect on skin structure when examined microscopically.

Executive summary:

Cocoa polyphenols exhibited a positive effect on skin structure when applied for at least 5 days. Cocoa butter also had a positive effect, but with evidence of action only observed after 12 days of treatment. CP doses of0.50% and 0.75% (in cocoa butter) were associated with improvements in ex vivo parameters associated with skin tonus and elasticity. At 0.5% and 0.75% CP, influence on GAGs and collagen expression was comparable with a commercially available “anti-aging” skin preparation.