Fatty acids, C16-18 and C18-hydroxy, oligomeric reaction products with adipic acid, decanoic acid, isooctadecanoic acid, octanoic acid, pentaerythritol and stearic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD guideline 431 (In vitro skin corrosion: Human skin model test) adopted 2004

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

921-836-0

EC Number:

921-836-0

IUPAC Name:

921-836-0

Details on test material:

- Name of test material (as cited in study report): [trade name]
- Composition: mixed ester of fatty acids, C 16 and C 16-18 unsaturated with adipic acid and pentaerithrytol
- Physical state/appearance: yellow liquid
- Analytical purity: no data
- Batch No.: 103991

In vitro test system

Test system:

human skin model

Remarks:

SkinEthic

Source species:

human

Cell type:

non-transformed keratinocytes

Vehicle:

other: PBS

Details on test system:

TEST SYSTEM
The test substance was applied topically on SkinEthic RHE tissues, a 3D system of reconstructed epidermis of normal human keratinocytes with a functional stratum corneum. Cells are grown on inert polycarbonate filter on chemically defined medium, airlifted for 17 days. The model exhibits normal barrier functions (presence of a differentiated stratum corneum).
- Supplier of SkinEthic RHE tissue, maintenance medium (SMM) and growth medium (SGM): SkinEthic

PRE-TEST
The test product was put in contact with MTT (thiazolyl blue tetrazolium) solution to detect non-specific reduction of MTT. 40 µL of sample were incubated for 3 hours at 37 °C with 300 µL of MTT ready to use, water was used as negative control. At the end of this period a visual observation was performed and interpreted according to the following criteria:
Yellow: no interaction; light blue: slight interaction; dark blue: strong interaction
If the MTT solution becomes blue or purple the sample interact with MTT and is necessary to evaluate the part of optical density due to a non-specific reduction of the MTT.

MAIN TEST
The test product, the negative and positive control were applied in duplicate on the tissues for 3 minutes and 1 hour at room temperature.
At the end of the exposure time the product and the controls were removed from the tissues and the tissues rinsed for 5 times with PBS.
After the post treatment the tissues were treated for 3 hours at 37 °C, 5% Co2 with MTT ready to use and then put in contact with 1.5 mL of isopropanol for 2 hours at room temperature with gentle agitation for formazan extraction.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

40 ± 0.5 µL

Duration of treatment / exposure:

3 min and 1 h

Duration of post-treatment incubation (if applicable):

3 h

Number of replicates:

Triplicates each in 2 independent experiments

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 min exposure

Value:

88.98

Vehicle controls validity:

not examined

Negative controls validity:

valid

Remarks:

100

Positive controls validity:

valid

Remarks:

0.59

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

60 min exposure

Value:

88.5

Vehicle controls validity:

not examined

Negative controls validity:

valid

Remarks:

100

Positive controls validity:

valid

Remarks:

0.42

Any other information on results incl. tables

Table 1: Individual values: optic density (OD) at 570 nm; 3 minutes treatment

3 min	1	2	3	4	5	6	Mean	%Viability
Blank	0.086	0.087	0.091	0.089	0.088	0.088	0.088	-
Negative control	1.255	1.269	1.266	1.266	1.266	1.271	1.266	100%
Positive control	0.095	0.093	0.094	0.096	0.095	0.096	0.095	0.59%
Sample	1.121	1.141	1.139	1.147	1.133	1.145	1.138	88.98%

 

Table 2: Individual values: optic density (OD) at 570 nm; 1 hour treatment

1 h	1	2	3	4	5	6	Mean	%Viability
Blank	0.087	0.087	0.088	0.092	0.087	0.086	0.088	-
Negative control	1.297	1.275	1.281	1.280	1.293	1.279	1.284	100%
Positive control	0.093	0.091	0.093	0.094	0.093	0.092	0.093	0.42%
Sample	1.152	1.155	1.151	1.144	1.155	1.142	1.150	88.5%

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008

Conclusions:

Under the conditions of the Human skin model test the test substance possessed no corrosive properties towards the skin.