Phosphonic acid, P-2-propen-1-yl-, diethyl ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 Jan 2015 to 19 Jan 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study performed according to the guideline and under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Principles of method if other than guideline:

exposure period 15 minutes with post-exposure incubation period of 42 hours

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Diethyl allylphosphonate

EC Number:

619-646-5

Cas Number:

1067-87-4

Molecular formula:

C7H15O3P

IUPAC Name:

Diethyl allylphosphonate

Test material form:

other: liquid

Details on test material:

Identification: Diethyl Allylphosphonate
Appearance/Physical State: Clear colorless liquid

Test system

Details on study design:

The EpiSKIN assay uses reconstructed human epidermis to assess skin irritation. For the viability test enzymatic conversion of MTT to formazan is used.

In a pre-test direct interaction of the test substance with the detection chemical MTT is assessed. No interference was determined.

In the main study triplicate tissues were treated with 10 uL of the test substance during 15 minutes. In addition triplicate tissues were treated with a negative control (DPBS) and a positive control (5% SDS). After treatment tissues were rinsed, incubated in maintenance fluid for 42 hours at 37 °C (5% CO2) and treated with MTT during 3 hours (at 37 °C/5% CO2). After MTT loading a total biopsy of each epidermis (epidermis and collagen) was made, that was suspended in acidified isopropanol for 3 days and kept in the refrigerator at 1-10°C. Thereafter the optical density of the extracted MTT solutions was measured at 562 nm. Viability was expressed as percentage MTT conversion versus negative control
Tissue viability > 50% means non-irritant
Tissue viability ≤ 50% means irritant

Results and discussion

In vivo

Other effects:

The test substance did not interfere with the reduction of MTT to blue formazan salt

Any other information on results incl. tables

	Mean OD562± SD	Relative mean viability ± SD
Negative control:	0.827 ± 0.02	100 ± 2.9%
Test substance:	0.822 ± 0.05	99.4 ± 6.3%
SDS:	0.243 ± 0.06	29.4 ± 7.4%

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: tissue viability > 50%: non-irritant

Conclusions:

The test substance is non-irritant in the EPISKIN reconstructed human epidermal model.

Executive summary:

In this assay reconstructed human skin tissues were treated with 10 uL of the test substance in triplicate during 15 minutes. After treatment tissues were rinsed, kept for 42 hours and treated with MTT. Optical density of extracted MTT solutions was measured at 562 nm. The viability was 99.4%, which is indicative for non-irritant substances.

The test substance is non-irritant in the EPISKIN reconstructed human epidermal model.