Ethanol, 2,2'-iminobis-, N-C12-18-alkyl derivs.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

ca. September-October 1967

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1967

Report date:

1967

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

6 animals instead of 3 animals; no observations at 60 min, or after 3 days

Principles of method if other than guideline:

According to FDA - Federal Register, 17 September 1964, par. 191.12

GLP compliance:

no

Remarks:

pre-GLP

Test material

Test material information

Constituent 1

Reference substance name:

Ethanol, 2,2'-iminobis-, N-C12-18-alkyl derivs.

EC Number:

276-014-8

EC Name:

Ethanol, 2,2'-iminobis-, N-C12-18-alkyl derivs.

Cas Number:

71786-60-2

Molecular formula:

Not applicable

IUPAC Name:

2,2'-(C12-18 evennumbered alkyl imino) diethanol

Test material form:

liquid: viscous

Details on test material:

- Chemical name: Ethanol, 2,2'-iminobis-, N-C12-18-alkyl derivs.
- EC number: 276-014-8

To the best of knowledge, the sample used is representative to the boundary composition shared and agreed by each registrant.

Test animals / tissue source

Species:

rabbit

Strain:

other: albino

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data


IN-LIFE DATES: somewhere between 26 September 1967 (receipt of test material) and 17 November 1967 (date of report).

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

single application in one eye

Observation period (in vivo):

3 days

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): if done, after the 24-h reading (according to protocol)

SCORING SYSTEM (Fed. Reg. 17 SEptember 1964, Sec. 191.12):

1. CORNEA
No ulceration or opacity 0
Scattered or diffuse areas of opacity, details of iris clearly visible 1*
Easily discernible translucent areas, details of iris slightly obscured 2
Nacreous areas, no details of iris visible, size of pupil barely discernible 3
Complete corneal opacity, iris invisible 4

2. IRIS
Normal 0
Folds above normal, congestion, swelling, circumcorneal injection
(any or all of these or combination of any thereof), iris still reacting to light
(sluggish reaction is positive) 1*
No reaction to light, haemorrhage, gross destruction (any or all of these) 2

3. CONJUNCTIVAE
Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal 0
Some vessels definitely injected 1
Diffuse, crimson red, indiviual vessels not easily discernible 2*
Diffuse beefy red 3

Chemosis
No swelling 0
Any swelling above normal (includes nictitating membrane) 1
Obvious swelling with partial eversion of lids 2*
Swelling with lids about half closed 3
Swelling with lids more than half closed 4
* = considered positive

TOOL USED TO ASSESS SCORE: fluorescein (after the 24-h reading)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not specified

Remarks on result:

other: no observations after 3 days

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not specified

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not specified

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not specified

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not specified

Remarks on result:

other: no observations after 3 days

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not specified

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.67

Max. score:

3

Reversibility:

not specified

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.67

Max. score:

3

Reversibility:

not specified

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.67

Max. score:

3

Reversibility:

not specified

Remarks on result:

other: no observations after 3 days

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not specified

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.67

Max. score:

3

Reversibility:

not specified

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3.33

Max. score:

4

Reversibility:

not specified

Results 13

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not specified

Remarks on result:

other: no observations after 3 days

Results 14

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not specified

Results 15

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2.33

Max. score:

3

Reversibility:

not specified

Results 16

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2.33

Max. score:

3

Reversibility:

not specified

Results 17

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

2.67

Max. score:

3

Reversibility:

not specified

Remarks on result:

other: no observations after 3 days

Results 18

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not specified

Results 19

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not specified

Results 20

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not specified

Results 21

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not specified

Remarks on result:

other: no observations after 3 days

Results 22

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not specified

Results 23

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not specified

Results 24

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

3.33

Max. score:

4

Reversibility:

not specified

Irritant / corrosive response data:

All 6 eyes showed a positive reaction consisting of corneal opacity, iritis, and severe conjunctivitis. The conjunctivae were
obviously swollen causing almost complete closure of the eyelids.

Other effects:

No data

Any other information on results incl. tables

Summary of ocular lesions

Anim. No.	Effect	Hours	Days after application					Mean score cornea Days 1/2/3	Mean score iritis Days 1/2/3	Mean score redness Days 1/2/3	Mean score chemosis Days 1/2/3
		1	1	2	3	7	21
1	Cornea Iris Redness Chemosis	- - - -	2 1 3 3	2 1 3 3	2 1 3 3	- - - -	- - - -	2.0	1.0	3.0	3.0
2	Cornea Iris Redness Chemosis	- - - -	2 1 3 3	2 1 3 3	2 1 2 2	- - - -	- - - -	2.0	1.0	2.67	2.67
3	Cornea Iris Redness Chemosis	- - - -	2 1 3 4	3 1 3 3	3 1 2 3	- - - -	- - - -	2.67	1.0	2.67	3.33
4	Cornea Iris Redness Chemosis	- - - -	2 1 3 3	2 1 2 2	2 1 2 2	- - - -	- - - -	2.0	1.0	2.33	2.33
5	Cornea Iris Redness Chemosis	- - - -	2 1 3 4	3 1 3 4	3 1 3 4	- - - -	- - - -	2.67	1.0	3.0	4.0
6	Cornea Iris Redness Chemosis	- - - -	2 1 3 4	2 1 3 3	2 1 3 3	- - - -	- - - -	2.0	1.0	3.0	3.33
Mean all anim.								2.22	1.0	2.78	3.11

- = no observation done

Applicant's summary and conclusion

Interpretation of results:

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

Remarks:

Migrated information

Conclusions:

The test compound was irritating to the rabbit eye. Because no information is available on reversibility within 21 days, based on the type and severity of the changes observed (corneal opacity, iritis, and severe conjunctivitis; the conjunctivae were obviously
swollen causing almost complete closure of the eyelids), it is expected that changes might still be present after 21 days. Therefore, the test compound was classified Category 1 according to OECD-GHS.

Executive summary:

A study was performed to assess the irritancy potential of the test material to the eye of albino rabbits. The method used generally followed that described in the OECD Guidelines for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion". A single application of the test material to the non-irrigated eye of six rabbits produced clear corneal opacity, moderate iritis, and severe conjunctival irritation. The conjunctivae were obviously swollen causing almost complete closure of the eyelids. Observations were made up to 72 h after exposure; therefore no information is available on

reversibility.

The test compound was irritating to the rabbit eye. Because no information is available on reversibility within 21 days, based on the type and severity of the changes observed (corneal opacity, iritis, and severe conjunctivitis), it is expected that changes may still be present after 21 days. Therefore, the test compound was classified Category 1 according to OECD-GHS.