1,1',1'',1'''-ethylenedinitrilotetrapropan-2-ol

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: Guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,1',1'',1'''-ethylenedinitrilotetrapropan-2-ol

EC Number:

203-041-4

EC Name:

1,1',1'',1'''-ethylenedinitrilotetrapropan-2-ol

Cas Number:

102-60-3

Molecular formula:

C14H32N2O4

IUPAC Name:

1-({2-[bis(2-hydroxypropyl)amino]ethyl}(2-hydroxypropyl)amino)propan-2-ol

Details on test material:

- Name of test material (as cited in study report): Lutropur Q
- Physical state: liquid, unchanged
- Analytical purity: technical
- Impurities: none
- Lot/batch No.: P. 282

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: male: 3.0 kg; females 3.03 kg mean
- Housing: single
- Diet: 130 g/animal/day
- Water: 250 ml/day
- Acclimation period: at least 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: negative control: untreated eye

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:

not washed out

Observation period (in vivo):

15 days

Number of animals or in vitro replicates:

3 (1 male, 2 females)

Details on study design:

SCORING SYSTEM: OECD Draize (OECD 405)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24, 48, 72 h

Score:

1

Reversibility:

fully reversible within: 8 d

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24, 48, 72 h

Score:

1

Reversibility:

fully reversible within: 15 d

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 24, 48, 72 h

Score:

1

Reversibility:

fully reversible within: 15 d

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

1

Reversibility:

fully reversible within: 15 d

Results 5

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24, 48, 72 h

Score:

0.3

Reversibility:

fully reversible within: 72 h

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24, 48, 72 h

Score:

1

Reversibility:

fully reversible within: 8 d

Results 7

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 24, 48, 72

Score:

0.3

Reversibility:

fully reversible within: 72 h

Results 8

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.6

Reversibility:

fully reversible within: 8 d

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24, 48, 72 h

Score:

2

Reversibility:

fully reversible within: 8 d

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24, 48, 72 h

Score:

2

Reversibility:

fully reversible within: 15 d

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24, 48, 72 h

Score:

2

Reversibility:

fully reversible within: 15 d

Results 12

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

2

Reversibility:

fully reversible within: 15 d

Results 13

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24, 48, 72 h

Score:

0.3

Reversibility:

fully reversible within: 48 h

Results 14

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24, 48, 72 h

Score:

0.7

Reversibility:

fully reversible within: 72 h

Results 15

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24, 48, 72 h

Score:

1

Reversibility:

fully reversible within: 8 d

Results 16

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.7

Reversibility:

fully reversible within: 8 d

Other effects:

Symptoms:
Animal 1: pupil contracted from 1 to 72 h; small retractions of the eyelids from 24 h till the end of the observation period; loss of corneal tissue at 72 h
Animal 2: pupil contracted from 1h to 8 d; small retractions in the eyelids from 24 h till the end of the observation period; loss of corneal tissue from 24 h to 8 d; suppuration at 48 and 72 h
Animal 3: loss of corneal tissue from 24 h to 8 d; pupil contracted from 48 h to 8 d; small retractions of the eye lids from 48 h till the end of the observation period; suppuration at 48 and 72 h; loss of hair at margins of eyelids from 8 d till the end of the observation period

Any other information on results incl. tables

Table of individual scores:

Readings	animal	Cornea	Iris	Conjuctiva
				Redness	Chemosis
24 h	1	1	0	2	1
	2	1	1	2	1
	3	1	0	2	1
48 h	1	1	1	2	0
	2	1	1	2	1
	3	1	0	2	1
72 h	1	1	0	2	0
	2	1	1	2	0
	3	1	1	2	1
8 d	1	0	0	0	0
	2	1	0	2	0
	3	1	0	2	0
15 d	1	0	0	0	0
	2	0	0	0	0
	3	0	0	0	0