2,2'-[oxybis(2,1-ethanediyloxy)]bisacetic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-12-04 to 1990-12-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1984

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-[oxybis(2,1-ethanediyloxy)]bisacetic acid

EC Number:

237-655-9

EC Name:

2,2'-[oxybis(2,1-ethanediyloxy)]bisacetic acid

Cas Number:

13887-98-4

Molecular formula:

C8H14O7

IUPAC Name:

2-{2-[2-(carboxymethoxy)ethoxy]ethoxy}acetic acid

Test material form:

other: liquid: clear colourless

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
- Weight at study initiation: 3.1 - 4.1 kg
- Housing: individually
- Diet: ad libitum (Altromin 2123), hay
- Water: ad libitum (deionised, chlorated water)

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

single treatment, the eyes were washed out after 24 hours

Observation period (in vivo):

1, 24, 48 and 72 hours after application

Number of animals or in vitro replicates:

3 animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: Yes (physiological saline solution)
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3.7

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 72 hours

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 72 hours

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 72 hours

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Irritant / corrosive response data:

Up to 72 hours p.a., conjunctivae of all animals were red and swollen, eyelids were half to fully closed. From 24 h p.a. onwards all animals exhibited a reddened iris. Clear-clourless to whitish discharge was observed. The animals were sacrificed 72 h p.a. due to severe signs of irritation.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

The test item is considered to cause serious eye damage in the rabbits' eye and classified into category 1.

Executive summary:

The acute eye irritation study of the test item was performed in three New Zealand White rabbits according to OECD 405. The irritation effect of the test item was evaluated according to the Draize method. A single dose of 0.1 mL of the test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. The treated eyes of the test animals were washed out 24 hours after application. The eyes were examined at 1, 24, 48, and 72 hours after the application. Up to 72 hours p.a., conjunctivae of all animals were red and swollen, eyelids were half to fully closed. From 24 h p.a. onwards all animals exhibited a reddened iris. Clear-clourless to whitish discharge was observed. The animals were sacrificed 72 h p.a. due to severe signs of irritation. Based on these findings the test item was considered to cause serious eye damage and classified into category 1.