Alcohols, C18-unsatd and ethoxylated C18-unsatd., phosphates (5 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:

2004

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

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, C18-unsatd and ethoxylated C18-unsatd., phosphates (5 moles ethoxylation)

Molecular formula:

C18H37O4P (representative of phosphate monoesters; i.e., mono- C18-unsatd. PSE) C28H57O9P1 (representative of ethoxylated phosphate monoesters; i.e., mono- C18-unsatd. AE5 PSE) C36H71O4P1 (representative of phosphate diesters; i.e., di- C18-unsatd. PSE) C46H91O8P1 (representative ethoxylated phosphate diesters; di- C18-unsatd. PSE and C18-unsatd. AE5 PSE) C82H161O21P1 (representative ethoxylated phosphate diesters; di- C18-unsatd. AE5 PSE)

IUPAC Name:

Alcohols, C18-unsatd and ethoxylated C18-unsatd., phosphates (5 moles ethoxylation)

Test material form:

liquid

Specific details on test material used for the study:

Lot no.: 146-100

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:

50 µL test substance, negative or positive control

Duration of treatment / exposure:

3 minutes and 1 hour

Number of replicates:

3

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Remarks:

cells after 3 min

Run / experiment:

MTT test (mean viability compared to the negative control - %)

Value:

78

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 2

Irritation / corrosion parameter:

% tissue viability

Remarks:

cells after 1 h

Run / experiment:

MTT test (mean viability compared to the negative control - %)

Value:

91

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

The test substance did not induce a significant decrease of tissue viability with values of 78 and 91% after 3 min and 1 h, respectively.
The positive control induced a significant decrease of tissue viability with values of 29 and 17% after 3 min and 1 h, respectively.

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria for corrosion not met

Remarks:

non-corrosive

Conclusions:

Under the study conditions, the test substance (pH 6.20) did not induce a significant tissue mortality and was therefore predicted to be non-corrosive to skin.

Executive summary:

A study was conducted to determine the in vitro skin irritation potential of the test substance, 'mono- and di- C18-unsatd PSE and C18-unsatd. AE5 PSE', using Reconstructed Human Epidermis (RHE) cells, according to a method similar to OECD Guideline 431, in compliance with GLP. Three replicates of 50 µL test substance (undiluted) were applied topically for 3 minutes or 1 h to the model skin surface. Distilled water and potassium hydroxide were used as negative and positive controls respectively. 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 time at which 50% percent viability was acheived (ET-50) was estimated for each tissue. The test substance did not induce a significant decrease of tissue viability with values of 78 and 91% after 3 min and 1 h, respectively. The positive control induced a significant decrease of tissue viability with values of 29 and 17% after 3 min and 1 h, respectively. Therefore, the study met the validity criteria. Under the study conditions, the test substance (at pH 6.20) was predicted to be non-corrosive to skin (CPT, 2004).