Phosphonic acid, monoethyl ester, sodium salt (1:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 - 24 May 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(adopted in July 1992) and current version of 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

(adopted in July 1992)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

(adopted August 1998)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Republique Francaise, Premier Ministre, Groupe Interministeriel Des Produits Chimiques, Paris Cedex, France

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

444-960-2

EC Name:

-

Cas Number:

39148-16-8

Molecular formula:

C2H6O3P.Na

IUPAC Name:

sodium ethyl phosphonate

Test material form:

solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France
- Weight at study initiation: 2.6 ± 0.2 kg
- Housing: individually in polystyrene cages
- Diet: 110 pelleted diet (UAR, Villemoisson, Epinay-sur-Orge, France), ad libitum
- Water: filtered water (FG Millipore membrane (0.22 micron)), ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 12
- Photoperiod (hrs dark / hrs light): (12 / 12)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Remarks:

the gauze pad was moistened with distilled water prior to treatment to ensure good contact with the skin

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

3 min and 4 h

Observation period:

72 h
Reading time points: 1, 24, 48 and 72 h

Number of animals:

1 male (initial test, treatment for 3 min on one flank and for 4 h on the other flank)
2 males (4 h exposure)

Details on study design:

TEST SITE
- Area of exposure: 3 min exposure: left flank (initial test animal); 4 h exposure: right flank (3 test animals)
- Type of wrap if used: The treated skin was covered by an adhesive hypoallergenic aerated dressing and a restraining bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was wiped off with a dry cotton pad.
- Time after start of exposure: 3 min (initial test animal) or 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritant / corrosive response data:

Topical application of the test substance for 3 min did not induce cutaneous reactions in the initial test animal. After elongation of the exposure time to 4 h, one animal revealed a very slight erythema (scored with grade 1) visible 1 h after removal of the dressing. No skin reactions were noted at the following reading time points.

Any other information on results incl. tables

Table 1: Four -hour exposure - Individual cutaneous examinations and mean values of the scores recorded for each animal (24, 48, and 72 hours)

Observation time	Rabbit no.
	1		2		3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 h	0	0	0	0	1	0
24 h	0	0	0	0	0	0
48 h	0	0	0	0	0	0
72 h	0	0	0	0	0	0
Mean value 24 + 48 + 72 h	0.00	0.00	0.00	0.00	0.00	0.00

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 chosen, the test substance did not induce skin irritation to the skin of rabbits.