Fatty acids, C12-18 and C18-unsatd., reaction products with chloroacetic acid and 2-(dimethylamino)ethanol and N,N-dimethyl-1,3-propanediamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19.06.2018 - 15.08.2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

Version / remarks:

In Vitro Skin Corrosion: reconstructed human epidermis (RHE) test method”, (adopted 29 July 2016).

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C12-18 and C18-unsatd., reaction products with chloroacetic acid and 2-(dimethylamino)ethanol and N,N-dimethyl-1,3-propanediamine

EC Number:

295-171-3

EC Name:

Fatty acids, C12-18 and C18-unsatd., reaction products with chloroacetic acid and 2-(dimethylamino)ethanol and N,N-dimethyl-1,3-propanediamine

Cas Number:

91845-01-1

Molecular formula:

C24H48NO4, C25H51N2O3

IUPAC Name:

2-(dimethylamino)ethyl hexadecanoate; 2-(dimethylamino)ethyl octadecanoate; N-[3-(dimethylamino)propyl]hexadecanamide; N-[3-(dimethylamino)propyl]octadecanamide

Test material form:

solid: bulk

In vitro test system

Test system:

human skin model

Source species:

other: Human EpiDerm Skin Model, EPI-200

Cell type:

other: Human-derived epidermal keratinocytes

Cell source:

other: Multilayered, highly differentiated model of the human epidermis

Source strain:

other: EPI-200, Lot no.: 28811, kit L and M

Justification for test system used:

Recommended test system in international guidelines (OECD and EC).

Vehicle:

water

Details on test system:

EpiDerm Skin Model (EPI-200, Lot no.: 28811, kit L and M
The model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm tissues (surface 0.6 cm²) were cultured on polycarbonate membranes of 10 mm cell culture inserts.

Control samples:

yes, concurrent MTT non-specific colour control

Amount/concentration applied:

51.1 to 65.0 mg

Duration of treatment / exposure:

3 min., 1 hour

Duration of post-treatment incubation (if applicable):

3 min.

Number of replicates:

3

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1 hour, 3 min.

Value:

>= 88 - <= 96

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

other: Not corrosive

Conclusions:

In conclusion, 03590 is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.

Executive summary:

The study procedures described in this report were based on the most recent OECD and EC guidelines. Batch 51716 of 03590 was a beige brown solid.  Skin tissue was moistened with 25 µL of

Milli-Q water and at least 25 mg of 03590 was applied directly on top of the skin tissue. The positive control had a mean relative tissue viability of 8.7% after the 1-hour exposure. The absolute mean OD 570  (optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit 2.8) and the laboratory historical control data range.  In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was <10%, indicating that the test system functioned properly. Skin corrosion is expressed as the remaining cell viability after exposure to the test item.  The relative mean tissue viability obtained after 3-minute and 1-hour treatments with 03590 compared to the negative control tissues was 96% and 88%, respectively.  Because the mean relative tissue viability for 03590 was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment 03590 is considered to be not corrosive.