2,2'-iminodiethanol

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:

other: Basic data provided

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1968

Report date:

1967

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

BASF-Test

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-iminodiethanol

EC Number:

203-868-0

EC Name:

2,2'-iminodiethanol

Cas Number:

111-42-2

Molecular formula:

C4H11NO2

IUPAC Name:

2,2'-iminodiethanol

Details on test material:

- Name of test material (as cited in study report): Diethanolamine, Substance-No. XVII/144 (pure) and XVII/146 (technical grade)

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

- Weight at study initiation: 3.0 - 3.5 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: NaCl

Amount / concentration applied:

- Amount(s) applied (volume or weight with unit): 0.05 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:

not applicable; substance was not washed out and remained in the conjunctival sac of the eye

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Details on study design:

- Washing (if done): none

Readings: 24 h, 48 h, 72 h and 8 days


SCORING SYSTEM: the original scoring system was converted into Draize scores

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 3

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 4

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 48 h

Score:

1

Max. score:

4

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 48 h

Score:

2

Max. score:

2

Results 9

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 48 h

Score:

0

Max. score:

4

Results 10

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 48 h

Score:

1

Max. score:

4

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 48 h

Score:

2

Max. score:

4

Results 12

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 48 h

Score:

1

Max. score:

4

Results 13

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 72 h

Score:

1

Max. score:

4

Results 14

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 72 h

Score:

2

Max. score:

4

Results 15

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Results 16

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 72 h

Score:

2

Max. score:

4

Results 17

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 72 h

Score:

1

Max. score:

4

Results 18

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 8 days

Score:

0

Max. score:

4

Results 19

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 8 days

Score:

1

Max. score:

4

Irritant / corrosive response data:

Product tested:(XVII/144; pure): 
Observations: Superficial corrosion, distinct corneal opacity (grade: ++), conjunctival  bleeding, distinct conjunctival redding, distinct edema, conjunctival  scale

Product tested: (XVII/146; technical grade):
Observations: Superficial corrosion, distinct corneal opacity (grade: ++), conjunctival  bleeding, distinct conjunctival redding, distinct edema, conjunctival  scale

There was no difference between the pure and the technical product in respect to eye irritation, therefore only the data for the pure product are shown in detail.

Any other information on results incl. tables

Readings	Animal	Cornea		Iris	Conjunctiva			Additional findings
		op	ar		red	ch	di
1 h	1	1	-	-	2	2	-	after 3 h corrosions of conjunctiva and nictitating membrane visible
	2	1	-	-	1	2	-	corrosions of conjunctiva and nictitating membrane visible
24 h	1	2	-	-	2	2	-	corrosions of conjunctiva and nictitating membrane visible
	2	2	-	-	1	2	-	mucosal bleedings
48 h	1	1	-	-	2	0	-	mucosal bleedings
	2	2	-	-	1	1	-	mucosal bleedings
72 h	1	1	-	-	2	0	-	mucosal bleedings
	2	2	-		1	0	-	mucosal bleedings
8 d	1	0	-	-	0	0	-	mucosal bleedings
	2	1	-	-	0	0	-	mucosal bleedings, scars eyelid
Mean 24 -72 h	1	1.33	-	-	2	0.66	-
	2	2	-	-	1	1	-
Mean 24-72 h	1-2	1.67	-	-	1.5	0.83	-