2-(2-aminoethoxy)ethanol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1966

Materials and methods

Principles of method if other than guideline:

BASF-Test, see details in remarks on results.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-aminoethoxy)ethanol

EC Number:

213-195-4

EC Name:

2-(2-aminoethoxy)ethanol

Cas Number:

929-06-6

Molecular formula:

C4H11NO2

IUPAC Name:

2-(2-aminoethoxy)ethan-1-ol

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): Aminodiglykol, 2-(2-Hydroxyaethoxy-)aethylamin
- Physical state: liquid
- Analytical purity: > 99 %

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.87 and 2.92 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent negative control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl

Duration of treatment / exposure:

8 days (single application)

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 h - 48 h - 72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 h - 48 h - 72 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 8 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 h - 48 h -72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 h - 48 h - 72 h

Score:

1.5

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Any other information on results incl. tables

Findings animal1/2:

Time

Opacity

Iritis

Erythema

Chemosis

1h

1/3

0/0

2/2

2/2

24h

1/3

0/0

2/2

2/2

48h

1/1

1/2

2/2

1/1

72h

3/3

1/2

2/2

1/2

8d

3/3

0/2

0/2

0/2

Mean values over 24h, 48h and 72h:

Animal1: Opacity: 1.7; Iritis: 0.7; Erythema: 2; Chemosis: 1.3;

Animal2: Opacity: 2.3; Iritis: 1.3; Erythema: 2; Chemosis: 1.7;

The application of the test substance caused moderate to severe corneal opacity, irritis, moderate erythema and slight to moderate chemosis.

At the end of the observation period after 8 days staphyloma and severe corneal opacity were noted. Severe corneal opacity, is considered to be an irreversible effect to ophthalmic tissue.

The original BASF grading was converted into the numerical grading according to the OECD Draize system.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

Irreversible effects on the eyes / serious damage to eyes

Executive summary:

In a primary eye irritation study in rabbits, 50 µL of the test substance caused moderate to severe irreversible corneal opacity, irritis, moderate erythema and slight to moderate chemosis. At the end of the observation period after 8 days staphyloma and severe corneal opacity were noted.