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Diss Factsheets

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: JORF protocol (NO300) of December 26, 1996.
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

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

Resultsopen allclose all
Irritation parameter:
other: coagulation
Run / experiment:
mean
Value:
ca. 0
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
other: Hemorrhage
Run / experiment:
mean
Value:
ca. 5
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
other: Hyperemia
Run / experiment:
mean
Value:
ca. 3
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
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.

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