Fatty acids, vegetable-oil, polymd., unreacted fraction

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 October 2017 - 12 October 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)

Version / remarks:

9th October 2017

Deviations:

yes

Remarks:

The pre-test incubation period was supposed to be 3 h ±15 min for the substance in water. The substance was only incubated for 1 hour. This deviation has no impact on the outcome of the study since the supplier protocol recommends “at least 1 hour”.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, vegetable-oil, polymd., unreacted fraction

EC Number:

273-100-7

EC Name:

Fatty acids, vegetable-oil, polymd., unreacted fraction

Cas Number:

68937-92-8

Molecular formula:

Substance is a UVCB - no structural or molecular formula is available.

IUPAC Name:

5-[(5E)-icos-5-enoyloxy]icosanoic acid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source: Sponsor
- Batch No.of test material: 1367S17301
- Expiration date of the lot/batch: 21 June 2018

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

50 µL

Duration of treatment / exposure:

30 minutes.

Duration of post- treatment incubation (in vitro):

The tissues were incubated for 120 minutes at 37 ± 1.5 °C in a humidified atmosphere of 5 ± 0.5% CO2 (post-treatment incubation).

Number of animals or in vitro replicates:

Duplicate.

Results and discussion

In vitro

Results

Irritation parameter:

other: Cell viability

Value:

102.3

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Any other information on results incl. tables

Cell viability results after treatment for 30 minutes.

Treatment Group	Tissue No.	OD 570 nm Well 1	OD 570 nm Well 2	Mean OD of 2 Wells	Mean OD of 2 Wells blank corrected	Mean OD of Treatment Group blank corrected	Rel. Viability [%] Tissue 1, 2 *	Absolute Value of the Difference of Rel. Viability Tissue 1,2 [%]	Mean Rel. Viability [%]**
Blank	-	0.035	0.036	0.035	0.000	-	-	-	-
Negative Control	1	1.674	1.636	1.655	1.619	1.606	100.8	1.7	100.0
	2	1.610	1.645	1.628	1.592		99.2
Positive Control	1	0.592	0.588	0.590	0.554	0.547	34.5	0.9	34.1
	2	0.577	0.574	0.576	0.540		33.6
Substance	1	1.685	1.687	1.686	1.651	1.642	102.8	1.1	102.3
	2	1.665	1.672	1.669	1.633		101.7

* Relative viability: (100 x (absorbance of test item/positive control/negative control)) / (mean absorbance of negative control)

** Mean relative viability: (100 x (absorbance of test item/positive control/negative control)) / (mean absorbance of negative control)

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not expected to be an eye irritant under the conditions of this study.

Executive summary:

In an in vitro eye irritation study human reconstructed cornea-like epithelium was exposed to the neat substance for 30-minutes. The viability value of the substance-exposed tissues did not decrease below 60%, therefore the substance is not considered to possess an eye irritating potential.