[2-(2-methoxyethoxy)ethoxy]acetic 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 1990-12-18

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-methoxyethoxy)ethoxy]acetic acid

EC Number:

240-162-1

EC Name:

[2-(2-methoxyethoxy)ethoxy]acetic acid

Cas Number:

16024-58-1

Molecular formula:

C7H14O5

IUPAC Name:

2-[2-(2-methoxyethoxy)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
- Age at study initiation: 3-5 months
- Weight at study initiation: 3.52 kg
- Housing: individual
- Diet: Altromin 2123 ad libitum
- Water: tap water ad libitum

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:

one treatment, after 24 hours the eye was washed

Observation period (in vivo):

1, 24, 48 and 72 hours after application

Number of animals or in vitro replicates:

1 animal

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

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.6

Max. score:

3

Reversibility:

not fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

In the treated eye the animal exhibited a difuse reddening of the conjunctiva and swellings, eyelids were more than half closed. Opactity of the cornea was observed, from the 7th day onwards no light reaction of the iris was observed any more. White discharge, whitish conjunctiva and ablation as well as bleeding of parts of the conjunctiva was observed. 14 days after treatment the cornea showed vascularisation and an uneven surface.

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 one New Zealand White rabbit 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 the animal. The untreated right eye served as control. The treated eye of the test animal was washed out 24 hours after application. The eye was examined at 1, 24, 48, and 72 hours after the application. In the treated eye the animal exhibited a difuse reddening of the conjunctiva and swellings, eyelids were more than halfly closed. Opactity of the cornea was observed, from the 7th day onwards no light reaction of the iris was observed any more. White discharge, whitish conjunctiva and ablation as well as bleeding of parts of the conjunctiva was observed. 14 days after treatment the cornea showed vascularisation and an uneven surface. Based on these findings the test item was considered to cause serious eye damage and classified into category 1.