Potassium 2-(4-chloro-2-methylphenoxy)propionate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17.10.2006 - 27.11.2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Mecoprop

EC Number:

230-386-8

EC Name:

Mecoprop

Cas Number:

7085-19-0

Molecular formula:

C10H11ClO3

IUPAC Name:

2-(4-chloro-2-methylphenoxy)propanoic acid

impurity 1

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

water

Test material form:

solid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

White rabbits of New Zealand strain were used in studies.
The rabbit was quarantined for 5 days and observed carefully during this time. Two male rabbits were used in the experiment: 10.5 months old and weighing 3.9 kg and 4 months old weighing 2.9 kg.

The day before the experiment rabbits purposed for study were examined for both eyes. Only this animal was used for the experiment that showed no eye irritation, eye defects nor visible cornea damages.

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

The powdered test material was administered in amount of 0.1 g to conjunctiva sack of one eye to one rabbit, by gentle distraction of lower eyelid. Then both eyelids were kept for a moment to protect against loosing of the test material. The other eye was control one. Following evaluation of the exposed eye and to confirm the obtained results the test material was administered to one eye of rabbit No 2 in the same manner as in case of rabbit No 1.

Observation period (in vivo):

After 1, 24, 48 and 72 hours as well as 7, 14 and 21 days since preparation administration condition of cornea, iris and conjunctiva were evaluated.

Number of animals or in vitro replicates:

2 female New Zeland White rabbits.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

7 d

Score:

1

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

14 d

Score:

0

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

21 d

Score:

0

Results 5

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Results 6

Irritation parameter:

iris score

Basis:

animal #1

Time point:

7 d

Score:

0

Results 7

Irritation parameter:

iris score

Basis:

animal #1

Time point:

14 d

Score:

0

Results 8

Irritation parameter:

iris score

Basis:

animal #1

Time point:

21 d

Score:

0

Results 9

Irritation parameter:

conjunctivae score

Remarks:

erythema

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

3

Results 10

Irritation parameter:

conjunctivae score

Remarks:

erythema

Basis:

animal #1

Time point:

7 d

Score:

3

Results 11

Irritation parameter:

conjunctivae score

Remarks:

erythema

Basis:

animal #1

Time point:

14 d

Score:

1

Results 12

Irritation parameter:

conjunctivae score

Remarks:

erythema

Basis:

animal #1

Time point:

21 d

Score:

0

Results 13

Irritation parameter:

conjunctivae score

Remarks:

edema

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Results 14

Irritation parameter:

conjunctivae score

Remarks:

edema

Basis:

animal #1

Time point:

7 d

Score:

1

Results 15

Irritation parameter:

conjunctivae score

Remarks:

edema

Basis:

animal #1

Time point:

14 d

Score:

0

Results 16

Irritation parameter:

conjunctivae score

Remarks:

edema

Basis:

animal #1

Time point:

21 d

Score:

0

Results 17

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Results 18

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

7 d

Score:

3

Results 19

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

14 d

Score:

3

Results 20

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

21 d

Score:

3

Results 21

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

1

Results 22

Irritation parameter:

iris score

Basis:

animal #2

Time point:

7 d

Score:

1

Results 23

Irritation parameter:

iris score

Basis:

animal #2

Time point:

14 d

Score:

0

Results 24

Irritation parameter:

iris score

Basis:

animal #2

Time point:

21 d

Score:

0

Results 25

Irritation parameter:

conjunctivae score

Remarks:

erythema

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

3

Results 26

Irritation parameter:

conjunctivae score

Remarks:

erythema

Basis:

animal #2

Time point:

7 d

Score:

2

Results 27

Irritation parameter:

conjunctivae score

Remarks:

erythema

Basis:

animal #2

Time point:

14 d

Score:

1

Results 28

Irritation parameter:

conjunctivae score

Remarks:

erythema

Basis:

animal #2

Time point:

21 d

Score:

0

Results 29

Irritation parameter:

conjunctivae score

Remarks:

edema

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Results 30

Irritation parameter:

conjunctivae score

Remarks:

edema

Basis:

animal #2

Time point:

7 d

Score:

2

Results 31

Irritation parameter:

conjunctivae score

Remarks:

edema

Basis:

animal #2

Time point:

14 d

Score:

1

Results 32

Irritation parameter:

conjunctivae score

Remarks:

edema

Basis:

animal #2

Time point:

21 d

Score:

0

Results 33

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 34

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Any other information on results incl. tables

Following administration of the test material, during observations pathological changes were noticed in cornea, iris and conjunctiva of both rabbits. During observation after 1 hour since administration of the test material rabbit No 1 showed cornea turbidity on its whole surface – details of iris were clearly visible. In rabbit No 2 iris details were somewhat blurred in lower part of cornea while clearly visible in upper part of cornea. Moreover, in iris of rabbit No 2 congestion and lazy pupil reaction to light were recorded. Conjunctiva of both rabbits showed broad redness of crimson color, congestion of the third eyelid, congestion around cornea, edema with eyelids partially turned out, edema of the third eyelid and secretion on eyelids, hair of eyelids and significant part of eye region.

During observation after 24 hours since administration of the test material in rabbit No 1 turbidity of cornea increased in half of front part – iris details were somewhat blurred while clearly visible in the remaining part. In rabbit No 2 iris details were somewhat blurred in half front part and clearly visible in half backside part of cornea. Iris of both rabbits still showed congestion and lazy pupil reaction to light. Moreover, conjunctiva of these rabbits showed broad redness of bloody color, congestion of the third eyelid, congestion around cornea and edema with eyelids partially turned out and edema of the third eyelid. Rabbit No 1 still showed secretion on eyelids, hair of eyelids and significant part of eye region while in rabbit No 2 amount of secretion diminished: secretion presence was recorded on eyelids and hair of eyelids.

During observation after 48 hours since administration of the test material in cornea of rabbit No 1 iris details were somewhat blurred in 1/3 front part and clearly visible in 2/3 backside part of cornea. Turbidity of the whole cornea surface were observed in rabbit No 2 – iris details were somewhat blurred. Iris and conjunctiva of both rabbits showed similar changes as those observed after 24 hours. Both rabbits showed secretion on eyelids and hair of eyelids, and additionally in rabbit No 2 purulent secretion was noticed.

During observation after 72 hours since administration of the test material cornea of both rabbits showed changes similar to those observed after 48 hours. No pathological changes were noticed in iris of rabbit No 1 while iris of rabbit No 2 still showed congestion and lazy pupil reaction to light. Moreover, conjunctiva of both rabbits showed broad redness of bloody color, congestion of the third eyelid and around cornea as well as edema with eyelids partially turned out and edema of the third eyelid. Rabbit No 2 still showed secretion on eyelids and hair of eyelids and purulent secretion while in rabbit No 1 amount of secretion diminished to insignificant.

During observation after 7 days since administration of the test material rabbit No 1 showed turbidity of cornea on its 1/3 lower part - details of iris were clearly visible. Also in this part of cornea blood vessels penetrating into middle part of cornea surface were noticed. In rabbit No 2 cornea turbidity increased – iris details were invisible in its 1/3 lower part and somewhat blurred in the other parts. Conjunctiva of rabbit No 1 showed broad redness of bloody color and minute edema while in rabbit No 2 broad redness of crimson color and edema with eyelids partially turned out. Moreover, two rabbits still showed congestion of the third eyelid, congestion around cornea and edema of the third eyelid. Small amounts of secretion were noticed only in rabbit No 2.

During observation after 14 days since administration of the test material rabbit No 1 did not show any pathological changes in cornea. In cornea of rabbit No 2 iris details were invisible in its 1/3 lower part and clearly visible in other parts. No pathological changes were noticed in iris of both rabbits. Conjunctiva of both rabbits showed minute

erythema in form of blood vessels congestion, congestion of the third eyelid and congestion around cornea. Moreover, rabbit No 2 showed edema of the third eyelid. No secretion was observed.

After 21 days since administration of the test material rabbit No 1 did not show any pathological changes in eye anymore. Rabbit No 2 showed cornea turbidity in its 1/3 lower part – iris details were invisible. Also in this part of cornea blood vessels penetrating into middle part of cornea surface were noticed. No pathological changes in iris and conjunctiva were noticed.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Tested material causes serious eye damage.

Executive summary:

The study was performed with white rabbits of New Zealand strain. The test material was administered in amount of 0.1 mL to conjunctiva sack of one eye of two rabbits.

After 1, 24, 48 and 72 hours and 7, 14 and 21 days since preparation administration condition of cornea, iris and conjunctiva were evaluated. After administration of the test material, during the observations, changes in cornea, iris and conjunctiva of rabbits' eyes were noticed.