Phosphoric acid, mixed esters with Bu alc. and ethylene glycol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Dec 1984 - Jan 1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Knapsack-Reinigerkomponente GB

IUPAC Name:

Knapsack-Reinigerkomponente GB

Test material form:

other: liquid

Details on test material:

colorless liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River France, 76410 Saint Aubin les Elbeuf, France
- Weight at study initiation: 2483 g
- Housing: individually in polystyrene cages (0.35 x 0.55 x 0.32 m)
- Diet (e.g. ad libitum): pelleted Rabbit Diet SQC (Special Diets Services Ltd., Witham, Essex, G.B.), ad libitum
- Water (e.g. ad libitum): filtered tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 50 +/- 30%
- Photoperiod (hrs dark / hrs light): 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the second eye served as control

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

The test substance was instilled into the inferior conjuncival sac of the left eye. During the treatment and 15 min later, the animals were maintained in restrainer cages. The eyes were not washed after application.

Observation period (in vivo):

1 hour post application
24 hours post application
48 hours post application
72 hours post application
from day 4 to day 22 post application daily

Number of animals or in vitro replicates:

6

Details on study design:

The eyes were examined 1 hour daily until day 22 after application of the test substance.
After treatment the eyes were not washed out.


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:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

4

Reversibility:

not reversible

Remarks on result:

not determinable

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Remarks on result:

not determinable

Remarks:

due to opacity of cornea

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not reversible

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

4

Remarks on result:

not determinable

Remarks:

lids of the animals could not be opened

Irritant / corrosive response data:

refer to any other information on results

Other effects:

animal no. 2 was found dead on day 12 post application

Any other information on results incl. tables

From the first hour after instillation, reactions of the conjunctivae, congestion of the iris and opacity of the cornea were visible. From day 2 until the end of the study, the observation of the iris was not possible because of the opacity of the cornea. Discharge disappeared. All the other reactions still persisted.

From day 15 to day 22, chemosis only could be scored because the lids of the animals could not be opened.

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 (chemosis: 4; redness: 2; opacity: 4 in all animals) and the irreversibility of the observed effects Phosphoric acid, mixed esters with Bu.Alc. and Ethylene glycol 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:

Phosphoric acid, mixed esters with Bu.Alc. and Ethylene glycol was tested for its eye irritant properties in 6 New Zealand White rabbits.The study was performed according to OECD Guideline 405.

Effects on conjunctivae, iris and cornea (chemosis score: 4; redness score: 2; opacity score: 4) were observed in all animals one hour after application and persisted to the study termination after 22 days. One animal was found dead on day 12 post application.

With reference the reported scores and the irreversibility of the observed effects Phosphoric acid, mixed esters with Bu.Alc. and Ethylene glycol

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).