2-methylaminoethanol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 Jun 1965 - 23 Jun 1965

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented report which meets basic scientific principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1965

Report date:

1965

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

BASF Test

Principles of method if other than guideline:

Method: BASF-Test. See further details in remarks on materials and methods.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-methylaminoethanol

EC Number:

203-710-0

EC Name:

2-methylaminoethanol

Cas Number:

109-83-1

Molecular formula:

C3H9NO

IUPAC Name:

2-(methylamino)ethan-1-ol

Details on test material:

- Name of test material (as cited in study report): Monomethylaethanolamin
- Analytical purity: 99-100 %

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.8 and 3.0 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The adjacent eye served as control treated with 0.9 % NaCl (saline).

Amount / concentration applied:

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

Duration of treatment / exposure:

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:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: 48 h reading is missing

Results 2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: 48 h reading is missing

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects

Remarks on result:

other: 48 h reading is missing

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Reversibility:

other: not specified

Remarks on result:

other: a precise evaluation of erythema score was not possible

Remarks:

.

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Reversibility:

other: not specified

Remarks on result:

other: a precise evaluation of erythema score was not possible

Remarks:

.

Any other information on results incl. tables

Findings animal1/animal2:

Time	Opacity	Iritis	Erythema	Chemosis
1h	3/3	0/0	x/x	0/0
24h	3/3	0/0	x/x	4/4
48h	-/-	-/-	-/-	-/-
72h	3/3	0/0	x/x	4/4
8d	3/3	0/0	x/x	4/4

-: The 48 h reading is missing.

x: a precise evaluation of erythema score was not possible.

Mean values over 24 h and 72 h (48 h reading is missing):

Animal1: Opacity: 3; Chemosis: 4; Erythema: x; Iritis: 0

Animal2: Opacity: 3; Chemosis: 4; Erythema: x; Iritis: 0

The application of the test substance caused within 10 minutes severe corneal opacity and corrosions of the mucous membrane. After 3 days purulent exsudate was noted. At the end of the observation period of 8 days symptoms were still persistent. Severe corneal opacity is considered to be 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:

The test substance is corrosive

Executive summary:

The test substance is corrosive