Protein hydrolyzates, milk

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Protein hydrolyzates, milk

EC Number:

296-575-2

EC Name:

Protein hydrolyzates, milk

Cas Number:

92797-39-2

IUPAC Name:

Protein hydrolyzates, milk

Test material form:

solid

In vitro test system

Test system:

human skin model

Remarks:

human three dimensional epidermal model (EPISKIN Small model (EPISKIN-SMTM)

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

foreskin from multiple donors

Source strain:

other: SkinEthic Laboratories, Lyon, France

Details on animal used as source of test system:

Epi-200-Kit Lot No.: 16858 Kit B

Justification for test system used:

In the interest of sound science and animal welfare, a sequential testing strategy is recommended to minimize the need of in vivo testing. One of the validated in vitro skin irritation tests is the EPISKIN test, which is recommended in international guidelines (e.g. OECD and EC).

Vehicle:

other: DPBS

Control samples:

yes, concurrent vehicle

Amount/concentration applied:

Each approximately 26 - 28 mg of the test item were applied to triplicate tissues, wetted
with 50 μL DPBS, and spread to match the surface of the tissues.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: mean realtive absorbance

Value:

89

Vehicle controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In conclusion, it can be stated that in this study and under the experimental conditions
reported, the test item YOGURTENE 20 CQ (PFR) U/A - 6099943 is not irritant to skin.

Executive summary:

This in vitro study was performed to assess the irritation potential of YOGURTENE 20 CQ

(PFR) U/A - 6099943 by means of the Human Skin Model Test.

Three tissues of the human skin model EpiDerm™ were treated with the test item, the

negative or the positive control for 60 minutes.

26 – 28 mg of the test item were applied to each tissue, wetted with 50 μL of DPBS, and

spread to match the tissue size.

30 μL of either the negative control (DPBS) or the positive control (5% Sodium lauryl

sulfate) were applied to each tissue.

After treatment with the negative control the absorbance values were well in the required

range of the acceptability criterion of mean OD ≥ 1.0 and ≤ 2.5 for the 60 minutes

treatment interval, thus assuring the quality of the tissues.

Treatment with the positive control induced a sufficient decrease in the relative

absorbance as compared to the negative control for the 60 minutes treatment interval,

and thus assuring the validity of the test system.

After treatment with the test item YOGURTENE 20 CQ (PFR) U/A - 6099943 the mean

relative absorbance value decreased to 89.0% compared to the relative absorbance value

of the negative control. This value is above the threshold for irritancy of ≤ 50%. Therefore,

the test item is not considered to possess an irritant potential.

In conclusion, it can be stated that in this study and under the experimental conditions

reported, the test item YOGURTENE 20 CQ (PFR) U/A - 6099943 is not irritant to skin.