Alcohols, C16-18 and ethoxylated C16-18 , phosphates (20 moles ethoxylation)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: MatTek Corporation EpiDermTM skin model in vitro toxicity testing system

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C16-18 and ethoxylated C16-18 , phosphates (20 moles ethoxylation)

Molecular formula:

C18H39O4P1 (monoester representative, i.e., mono- C18 PSE) C56H115O24P1 (ethoxylated monoester representative, i.e., mono- C16 AE20 PSE) C32H67O4P1 (diester representative, i.e., di- C18 PSE) C112H227O44P1 (ethoxylated diester representative, i.e., di- C16 AE20 PSE)

IUPAC Name:

Alcohols, C16-18 and ethoxylated C16-18 , phosphates (20 moles ethoxylation)

Test material form:

solid

In vitro test system

Test system:

human skin model

Remarks:

artificial three-dimensional model of human skin

Source species:

human

Cell type:

non-transformed keratinocytes

Justification for test system used:

Validated, accurate and reliable method for the prediction skin irritationg and no-label (no-skin irritating) test substances.

Vehicle:

unchanged (no vehicle)

Details on test system:

Three tissues were used for each treatment and concurrent control groups. The optical density (OD) was determined by using the MTT (3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue) reduction assay and expressed as relative percentage of viability of the negative control-treated tissues.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

- 25 mg neat test substance
- 50 µL of water
- 8N potassium hydroxide

Duration of treatment / exposure:

3 minutes or 1 h

Number of replicates:

3

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Remarks:

compared to negative control

Run / experiment:

3 min exposure

Value:

ca. 101

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks:

28% viability

Remarks on result:

other: no prediction of irritation

Results 2

Irritation / corrosion parameter:

% tissue viability

Remarks:

compared to negative control

Run / experiment:

1 h exposure

Value:

ca. 99

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks:

6% viability

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

The test substance did not reduce the viability to 50% or below and should be considered as non-corrosive to the skin.

Applicant's summary and conclusion

Interpretation of results:

other: not classified based on EU CLP criteria

Conclusions:

Under the study conditions, the test substance tested was determined to be non-corrosive to the skin.

Executive summary:

A study was conducted to determine the in vitro skin corrosion potential of the test substance, 'mono- and di- C16 -18 PSE and C16-18 AE20 PSE' using reconstructed human epidermis (RHE), according to a method similar to OECD Guideline 431, in compliance with GLP. Three replicates of 25 µg of the test substance (with 25 µL of distilled water), 50 µL of the negative control (water) and 8N positive control substance (8N Potassium hydroxide) were added to millicells MatTek Epiderm tissue samples for 3 minutes and 1 h time period. After exposure periods, the tissues were rinsed with phosphate buffered saline (PBS) to remove any residual material. After all tisses had been rinsed and dosed, they were placed for MTT assay. The MTT plates were then incubated for 3 h (at 37 ºC, 5% C02). After incubation period, the optical density (OD) was determined by using the MTT reduction assay and expressed as relative percentage of viability of the negative control-treated tissues. The mean viability of cells exposed to the test substance were 101% and 99% of the negative control after 3 min and 1 h, respectively. The test substance did not reduce the viability to 50% or below and should be considered as non-corrosive to the skin. Under the study conditions, the test substance tested was determined to be non-corrosive to the skin (CPT, 2003).