Phosphoric acid, dodecyl ester, potassium salt

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13. Jan - 20. Jan 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline and GLP conform study with sufficient reporting.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

77% paste in water tested

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Phosphoric acid, dodecyl ester, potassium salt

EC Number:

254-414-3

EC Name:

Phosphoric acid, dodecyl ester, potassium salt

Cas Number:

39322-78-6

Molecular formula:

not applicable

IUPAC Name:

potassium dodecyl hydrogen phosphate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breed
- Age at study initiation: 3-5 months
- Weight at study initiation: 2,5 - 3,3 kg
- Housing: single cages
- Diet (e.g. ad libitum): Altromin 2123 (Altromin GmbH, Lage/Lippe, Germany) ad libitum, 15 g hay/day
- Water (e.g. ad libitum): water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50 +/-20 %
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: From: 13. Jan 1987 To: 20. Jan. 1987

Test system

Vehicle:

water

Controls:

not required

Amount / concentration applied:

100 mg of 77% test substance in water

Duration of treatment / exposure:

24 h

Observation period (in vivo):

1 hour post application
24 hours post application
48 hours post application
72 hours post application
7 days post application

Number of animals or in vitro replicates:

3

Details on study design:

The eyes were examined 1, 24, 48, 72 hours and 7 days after application of the test substance.
24 hours after treatment the eyes were washed out with physological saline.
At 48 and 72 hours the eyes were also examined after instillation of one drop of 0.01 % fluorescein-sodium solution.

SCORING SYSTEM:

A. CORNEA
Degree of opacity (most dense area used)
No opacity ...................................................................................................................0
Scattered or diffuse areas, details of iris clearly visible........................................1
Easily discernible translucent areas, details of iris slightly obscured................2
Opalescent areas, no details of iris visible , size of pupil barely discernible ....3
Opaque, iris invisible, ulzeration ..............................................................................4

IRIS
Normal ......................................................................................................................... 0
Folds above normal , congestion, swelling, circumcorneal injection (any of all of these or combination of any thereof); iris still reacting to light
(sluggish reaction is positive) ......................... .........................................................1
No reaction to light, haemorrhage, gross destruction (any or all of these) ......2

CONJUNCTIVAE

A. Redness
Blood vessels normal...............................................................................................................0
Blood vessels definitely injected above normal ................................................................. 1
More diffuse, deeper crimson red, individual blood vessels not easily discernible .....2
Diffuse beefy red......................................................................................................................3

B. Chemosi s (refers to palpebral and bulbar conjunctivae)
No swelling .........................................................................................0
Any swelling above normal (includes nictitating membran) ..... 1
Obvious swelling with partial eversion of l i d s ...........................2
Swelling with lids about half closed ................................................3
Swelling with lids half closed to completely closed.......................4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

2.6

Max. score:

3

Reversibility:

not reversible

Results 2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

1.7

Max. score:

4

Reversibility:

not reversible

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.7

Max. score:

2

Reversibility:

not reversible

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

1.1

Max. score:

4

Reversibility:

not reversible

Any other information on results incl. tables

Individual scores:

Time after appl.	60 min.	24 h	48 h	72 h	7 d
Animal No.	1      2    3	1      2     3	1      2    3	1      2     3	1      2     3
Conjunctivae score	3      3    3	2      3     3	3      2    3	3      1     3	3     0     3
Chemosis score	3      2    3	1       1     2	1      1     3	2      1      3	2     0     2
Iris score	1      1     1	1       0      1	1      0     1	1      0      1	1     0     1
Cornea score	1      0     2	1       0      1	1      0     3	1      0      3	4     0     4

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

With reference the reported scores and the irreversibility of the observed effects Leomin PN has to be classified as irritant to the eyes (R41 - Risk of serious damage to the eyes; H318 - Causes serious eye damage) according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

Executive summary:

The test item was tested for its eye irritant properties in 3 New Zealand White rabbits.The study was performed according to OECD Guideline 405. The only deviation was that the test item was applied as 77% paste in water, but since the dry powder is moistened when it comes in contact with the eye, the testing conditions and results are considered to be the same.

Effects on conjunctivae (redness and swelling), iris and cornea were observed in all animals one hour after application. These signs were irrevesible in 2 of 3 animals.

With reference the reported scores and the irreversibility of the observed effects the test item has to be classified as irritant to the eyes (R41 - Risk of serious damage to the eyes; H318 - Causes serious eye damage) according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).