1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-C7-17-alkyl derivs.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

October 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Consistent with standard methodology at the time although prior to GLP Principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

limited description but close to standard test method

GLP compliance:

no

Remarks:

prior to GLP Principles

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, coco, reaction products with 2-[(2-aminoethyl)amino]ethanol

EC Number:

267-058-9

EC Name:

Fatty acids, coco, reaction products with 2-[(2-aminoethyl)amino]ethanol

Cas Number:

67784-90-1

IUPAC Name:

Fatty acids, coco, reaction products with 2-[(2-aminoethyl)amino]ethanol

Test animals / tissue source

Species:

rabbit

Strain:

other: no data (albino rabbits)

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: no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): as is

VEHICLE
no vehicle used

Duration of treatment / exposure:

The test material was instilled into the right eye, with no further treatment.

Observation period (in vivo):

The eyes were examined every 24 hours for 4 days and then again on the 7th day.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: no data

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

(Individual Mean for 24-48-72hrs)

Basis:

animal: #1, #2, #3

Time point:

other: 24-48-72 hr

Score:

4

Max. score:

4

Reversibility:

other: No reversibility observed up to d7

Remarks on result:

other: All 3 animals displayed the highest score.

Results 2

Irritation parameter:

iris score

Remarks:

(Individual Mean for 24-48-72hrs)

Basis:

animal: #1, #2, #3

Time point:

other: 24-48-72 hrs

Score:

2

Max. score:

2

Reversibility:

other: No reversibility observed up to d7

Remarks on result:

other: All 3 animals displayed the highest score

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(Individual Mean for 24-48-72hrs)

Basis:

animal: #1, #2, #3

Time point:

other: 24-48-72 hrs

Score:

3

Max. score:

3

Reversibility:

other: No reversibility observed up to d7

Remarks on result:

other: All 3 animals displayed the highest score

Results 4

Irritation parameter:

chemosis score

Remarks:

(Individual Mean for 24-48-72hrs)

Basis:

animal: #1, #2, #3

Time point:

other: 24-48-72 hrs

Score:

4

Max. score:

4

Reversibility:

other: No reversibility observed up to d7

Remarks on result:

other: All 3 animals displayed the highest score

Results 5

Irritation parameter:

other: discharge

Basis:

animal: #1, #2, #3

Time point:

other: observation period

Score:

3

Max. score:

3

Reversibility:

other: No reversibility observed up to d7

Remarks on result:

other: All 3 animals displayed the highest rating

Results 6

Irritation parameter:

maximum mean total score (MMTS)

Basis:

animal: #1, #2, #3

Time point:

other: for each time point

Score:

110

Max. score:

110

Reversibility:

other: No reversibility observed up to d7

Remarks on result:

other: MMTS for each animal

Irritant / corrosive response data:

All 3 animals displayed the maximal scores for each parameter and over the whole observation period (7 days). The corneal opacity involved the the whole area.
The observation period stopped on day 7 without any decrease in the intensity of the effects.

Other effects:

no data.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information (Risk of serious damage to the eyes) Criteria used for interpretation of results: EU

Conclusions:

Severe effects to the eyes.

Executive summary:

A test to determine the potential for eye irritation was conducted using three albino rabbits. Each animal was administered 0.1 ml of the test material to one eye with the other eye serving as a negative control. Observations were recorded at 24, 48, and 72 hours and again at 4 and 7 days.

The test substance induced severe damages to the eyes (maximum scores observed in all the animals for each of the parameters).

The test substance is considered to be an extreme irritant to rabbit eyes under the test conditions.