[No public or meaningful name is available]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: JORF protocol (NO300) of December 26, 1996.

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Hen’s Egg Test on the Chorio-Allantoic Membrane (HETCAM)

Principles of method if other than guideline:

This test is an in vitro method which assists in the evaluation of the eye irritant potential of a test item.
The principle is based on the observation of the irritant effects (hyperemia, hemorrhage, coagulation) which may occur within five minutes after the deposit of a test element on the ACM of an embryonated chicken egg, on the tenth day of incubation. Depending on the presence of these phenomena and their time of onset, a score is established.
The average of the scores obtained on 4 eggs makes it possible to note the test element and to classify it according to its ocular irritant potential.
This study is carried out according to the JORF protocol (NO300) of December 26, 1996.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Docosan-1-ol, icosan-1-ol, octadecan-1-ol and their reaction products with betaine and ethanesulphonic acid

IUPAC Name:

Docosan-1-ol, icosan-1-ol, octadecan-1-ol and their reaction products with betaine and ethanesulphonic acid

Test material form:

solid: bulk

Test animals / tissue source

Species:

chicken

Strain:

other: white leghorn

Details on test animals or tissues and environmental conditions:

Embryonated chicken egg (White Leghorn strain), weighing 50 to 65 g on the day of receipt.

-Reception of eggs
The reception of the eggs is carried out according to the instruction IL 01 in force.
Upon receipt, the cracked or broken eggs are discarded, the other eggs are weighed: the weight must be between 50 and 65 g. The weight of each egg is noted on its shell and will be transcribed on the score sheet at the time of the test. The eggs are stored in the dark and at 200C ± 5 0C until incubation.
- Incubation
The weighed eggs are incubated with the air pocket up (tip down).
Incubation takes place at 37.5 ° C. ± 0.5 ° C. with a relative humidity of 40 to 60% for 10 days in an egg incubator equipped with automatic oscillating plates. The study starts on the tenth day of incubation.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Duration of treatment / exposure:

After 20 seconds of contact, the membrane is rinsed with 5 ml of physiological serum at approximately 37 ° C., avoiding any sudden projection. The rinse aid is removed by tilting the egg. Any irritation phenomena are observed for 5 minutes. The time to onset of each phenomenon is noted.

Duration of post- treatment incubation (in vitro):

Any irritation phenomena are observed for 5 minutes. The time to onset of each phenomenon is noted.

Number of animals or in vitro replicates:

4 eggs
positive control: 2 eggs
negative control: 2 eggs

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

other: coagulation

Run / experiment:

mean

Value:

ca. 0

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation parameter:

other: Hemorrhage

Run / experiment:

mean

Value:

ca. 5

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Results 3

Irritation parameter:

other: Hyperemia

Run / experiment:

mean

Value:

ca. 3

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Results 4

Irritation parameter:

in vitro irritation score

Run / experiment:

mean

Value:

8

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Executive summary:

Under the retained experimental conditions, the irritant potential of the test item COSMEGREEN ES 1822+ code ID-20/01686 pure tested, may be classified as moderately irritant accoding to the adopted scale.