Poly(oxy-1,2-ethanediyl), .alpha.-[3-[(carboxymethyl)methylamino]-2-hydroxypropyl]-.omega.-(4-nonylphenoxy)-, sodium salt (1:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to: OECD Guideline for the testing of Chemicals 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method (Original Guideline adopted July 22, 2010)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

disodium 2-({2-hydroxy-3-[2-(4-nonylphenoxy)ethoxy]propyl}(methyl)amino)acetate 2-{[3-({1-chloro-3-[2-(4-nonylphenoxy)ethoxy]propan-2-yl}oxy)-2-hydroxypropyl](methyl)amino}acetate

EC Number:

616-248-3

Cas Number:

75627-31-5

Molecular formula:

UVCB not applicable

IUPAC Name:

disodium 2-({2-hydroxy-3-[2-(4-nonylphenoxy)ethoxy]propyl}(methyl)amino)acetate 2-{[3-({1-chloro-3-[2-(4-nonylphenoxy)ethoxy]propan-2-yl}oxy)-2-hydroxypropyl](methyl)amino}acetate

Details on test material:

Identity: Nonylphenol ethoxylate, sarcosine derivative
CAS No.: 75627-31-5
Batch-No.: 120229AAH
Appearance: Light yellow liquid
Purity: 81.7% weight % (dose calculation was adjusted to purity, see 9.4)
Stability in Solvent: Not relevant
Storage: At room temperature
Expiration Date: February 28, 2017

Test system

Amount / concentration applied:

Each 35.5 µL of the undiluted test item were applied to three EpiDerm (MatTek) tissues. Due to the purity of 81.7% of the test item, the applied volume was adjusted from 30 µL to 35.5 µL.

Duration of treatment / exposure:

The skin equivalents were exposed to the test item for 60 minutes. After completion of the treatment the test item was rinsed off and the skin equivalents were incubated for further 42 hours.

Details on study design:

Each 35.5 µL of the undiluted test item were applied to three EpiDerm (MatTek) tissues. Due to the purity of 81.7% of the test item, the applied volume was adjusted from 30 µL to 35.5 µL. From the negative control (DPBS) and the positive control (5% SLS) each 30 µL were applied to three tissues. The test item as well as the controls were rinsed off the tissues after 60 minutes treatment. After further 42 hours incubation the tissues were treated with the MTT solution for 3 hours following approximately 72 hours extraction of the colorant from the cells. The amount of extracted colorant was determined photometrically at a wavelength of 570 nm.

Results and discussion

In vivo

Irritant / corrosive response data:

After treatment with the of the test item Nonylphenol ethoxylate, sarcosine derivative the mean relative absorbance value was reduced to 5.3% (threshold for irritancy of ≤ 50%). Therefore, the test item is considered to possess an irritant potential.

Any other information on results incl. tables

Results after treatment with Nonylphenol ethoxylate, sarcosine derivative and the controls

 

Dose Group	Treatment Interval	Absorbance 570 nm Tissue 1*	Absorbance 570 nm Tissue 2*	Absorbance 570 nm Tissue 3*	Mean Absorbance of 3 Tissues	%Absorbance	Stand. Deviation	Mean Rel. Absorbance [% of Negative Control]**
Nega-tive Control	60 min	1.938	1.905	1.899	1.914	101.3 99.5 99.2	1.1	100.0
Positive Control	60min	0.086	0.082	0.090	0.086	5.2 5.4 5.4	0.2	4.5
Test Item	60 min	0.099	0.104	0.103	0.102	4.5 4.3 4.7	0.1	5.3

 

*       Mean of three replicate wells after blank correction
**      relative absorbance [rounded values]:

Optical evaluation of the MTT-reducing capacity of the test item after 1 hour incubation with MTT-reagent did not show blue colour.

The mean relative absorbance value of the test item, corresponding to the cell viability, decreased to 5.3% (threshold for irritancy:≤50%), consequently the test item was irritant to skin.

Since the present result was not borderline, the performance of the IL-1α Immunoassay was not necessary.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Nonylphenol ethoxylate, sarcosine derivative is irritant to skin category 2 according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008.

Executive summary:

This in vitro study was performed to assess the irritation potential of Nonylphenol ethoxylate, sarcosine derivative by means of the Human Skin Model Test.

Each three tissues of the human skin model EpiDerm^™ were treated with the test item, the negative or the positive control for 60 minutes.

35.5 µL of the undiluted test item were applied to each of triplicate tissues. Due to the purity of 81.7% of the test item, the applied volume was adjusted from 30 µL to 35.5 µL.

30 µL of either the negative control (DPBS) or the positive control (5% Sodium lauryl sulfate) were applied to each tissue.

The test item and the positive and negative controls were washed off the skin tissues after 60 minutes treatment. After further incubation for about 42 hours the tissues were treated with the MTT solution for 3 hours following approximately 72 hours extraction of the colorant from the cells. The amount of extracted colorant was determined photometrically at 570 nm.

After treatment with the negative control the mean absorbance values were well above therequired acceptability criterion of mean OD greater or equal than 1.0 and less or equal than 2.5 for the 60 minutes treatment interval thus showing the quality of the tissues.

Treatment with the positive control induced a decrease in the mean relative absorbance as compared to the negative control to 4.5% thus ensuring the validity of the test system.

The standard deviations between the % variabilities of the test item, the positive and negative controls were below 2% (threshold of the "OECD Guideline for the Testing of Chemicals 439: In vitro Skin Irritation: Reconstructed Human Epidermis Test Method”: 18%), thus ensuring the validity of the study.

After treatment with the test item Nonylphenol ethoxylate, sarcosine derivative the mean relative absorbance value was reduced to 5.3% (threshold for irritancy of ≤ 50%). Therefore, the test item is considered to possess an irritant potential.

Due to the unambiguous result of the test, the performance of the IL-1 α Immunoassay was not necessary.