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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 May - 31 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 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(adopted in February 1987)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2012

Deviations:

yes

Remarks:

No systemic analgesic was used sixty minutes before application, local analgesic applied two minutes prior to treatment instead of five minutes, no use of systemic analgesic after treatment

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

(adopted in July 1992)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Version / remarks:

(adopted in 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France
- Weight at study initiation: 2.8 ± 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

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

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

Number of animals or in vitro replicates:

3 males

Details on study design:

SCORING SYSTEM: Draize scoring system supplemented with scoring scale for discharge and area of opacity

TOOL USED TO ASSESS SCORE: fluorescein (on Day 2 and repeated thereafter whenever necessary)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibilty not applicable

Results 7

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 8

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48

Irritant / corrosive response data:

The test item induced slight to moderate effects on the conjunctivae (redness) in 3/3 test animals scored with grade 2 in 2/3 (animal # 2 and 3) and grade 3 in 1/3 animals (animal #1) 1 h after instillation of the test substance. Moreover, chemosis was observed in 3/3 animals at the same reading time point graded with 2 (animal #2) or 3 (animal # 1 and 3). 24 h after substance instillation, chemosis was observed in 2/3 animals (grade 1) which was fully reversible at the 48 h reading time point. Effects on the conjunctivae (redness) were still visible after 24 h (animal #2, grade 1; animal #1 and 3, grade 2) or 48 h (animal #1 and 3, grade 1) but were completely reversible in all animals after 72 h at the latest. No other ocular reactions were observed in the test animals.

Other effects:

Clear to whitish purulent discharge was noted in all animals (grade 2), which was reversible latest 48 h after instillation of the test substance.

Any other information on results incl. tables

Table 1: Results of eye irritation study

Rabbit #	Time [h]	conjunctivae		iris	cornea
		redness	swelling
1	1	3	3	0	0
	24	2	0	0	0
	48	1	0	0	0
	72	0	0	0	0
	average	1.0	0.0	0.0	0.0
2	1	2	2	0	0
	24	1	1	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.3	0.3	0.0	0.0
3	1	2	3	0	0
	24	2	1	0	0
	48	1	0	0	0
	72	0	0	0	0
	average	1.0	0.3	0.0	0.0

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 irritation to the eyes of rabbits.