2-diethylaminoethanol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26. Nov 1968 - 05. Dec 1969

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted prior to the implementation of current testing guidelines and GLP, according to a BASF internal testing method. The study is acceptable and the report well documented, meeting basic scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Materials and methods

Principles of method if other than guideline:

BASF Test:
50 µl of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. The eyes were not washed out after 24 hours as specified in OECD Guideline 405.

GLP compliance:

no

Remarks:

GLP was not compulsory at the time the study was conducted

Test material

Test material information

Constituent 1

Reference substance name:

2-diethylaminoethanol

EC Number:

202-845-2

EC Name:

2-diethylaminoethanol

Cas Number:

100-37-8

Molecular formula:

C6H15NO

IUPAC Name:

2-(diethylamino)ethanol

Details on test material:

- Name of test material (as cited in study report): 2-diethylaminoethanol
- Analytical purity: ca. 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: 2.42 and 2.52 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The adjacent eye served as saline-control.

Amount / concentration applied:

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

Duration of treatment / exposure:

single application, eyes not washed out

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Details on study design:

SCORING SYSTEM: The original BASF grading was converted into the numerical grading according the OECD Draize system.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of 2 animals

Time point:

other: 24 h - 48 h - 72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: irreversible damage to corneal tissue (staphyloma).

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

out of 2 animals

Time point:

other: 24 h - 48 h - 72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of 2 animals

Time point:

other: 24 h - 48 h - 72 h

Score:

1.5

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 4

Irritation parameter:

iris score

Remarks:

out of 2 animals

Basis:

mean

Time point:

other: 24 h - 48 h - 72 h

Score:

0

Max. score:

2

Reversibility:

other: no symptoms

Irritant / corrosive response data:

Severe findings like hemorrhage into the conjunctivae and purulent exsudates were observed throughout the study period, which were accompanied by conjunctival redness of grade 2 and chemosis of grades 2 to 3. Starting shortly after application corneal opacity was observed which persisted over the study period of 8 days and led to irreversible damage to corneal tissue (staphyloma). The findings indicate severe damage to the eye.

Any other information on results incl. tables

Findings: animal 1/animal 2

Time	Opacity	Iritis	Erythema	Chemosis
1 h	3/3	0/0	2/2	1/2
24 h	3/3	0/0	2/2	1/2
48 h	3/3	0/0	2/2	1/2
72 h	3/3	0/0	2/2	1/2
8 d	3/3	0/0	2/2	1/2