2,2'-(C12-14 evennumbered alkyl imino) diethanol

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:

comparable to guideline study with acceptable restrictions

Remarks:

Rationale for the reliability:Basic study data given, according to standards/guidelines; Observation limited to 72 hrs, no information is available on reversibility.

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:

mean

Time point:

24/48/72 h

Score:

2.22

Max. score:

3

Reversibility:

not specified

Remarks on result:

other: no observations after 3 days

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not specified

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

2.78

Max. score:

3

Reversibility:

not specified

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

3.11

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

Conclusions:

The eye irritation property of the registration substance is derived based on the read-across approach.
The supporting substance CAS 71786 -60 -2 was investigated for its eye irritation property in rabbits, the applied method corresponding to OECD Guideline 405. Within observation period of 3 days, effects indicative of Cat 1 according to GHS were observed.

Executive summary:

The eye irritation property of the registration substance is derived based on the read-across approach.

The read-across supporting substance CAS 71786 -60 -2 was investigated for its eye irritation property in rabbits. The method used generally followed that described in the OECD Guidelines 405 . 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 but it is expected that the changes may not fully reversible after 21 days. Based on these findings, Category 1 is justified.

.