Oils, fish, oxidized

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

end on 22-JUL-2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: in-vitro study performed according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

HET-CAM-Test according to Spielmann, H. et al. (1997) CAM-based Assays. Food and Chemical Toxicology 35, 39-66.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Oils, fish, oxidized

EC Number:

269-122-1

EC Name:

Oils, fish, oxidized

Cas Number:

68187-75-7

Molecular formula:

Not necessary

IUPAC Name:

Triglycerides C12-24, even, saturated and unsaturated, oxidized

Details on test material:

- Name of test material (as cited in study report): “Triglycerides, C12-24, saturated and unsaturated, oxidized”- Substance type: UVCB- Physical state: liquid- Stability under test conditions: data not available- Storage condition of test material: at room temperature

Test animals / tissue source

Species:

other: hen

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Test System: Fertilized hens eggs of the breed “White Leghorn” (Supplier: Lohmann Tierzucht, Cuxhaven, Germany), incubated for 9 days at 37,5 °C +/- 1,0 °C, rel. humidity 62,5 % +/- 7,5 %.

Test system

Vehicle:

unchanged (no vehicle)

Remarks:

The test item is applied directly

Controls:

no

Duration of treatment / exposure:

5 minutes

Observation period (in vivo):

5 minutes

Number of animals or in vitro replicates:

4 eggs for the test item and 2 eggs for each positive control are used

Details on study design:

Principle of the Test:The HET-CAM assay renders a statement about the irritation potential on eyes and mucous membrane of the tested substance. The test item is applied on the chorio allantoic membrane (CAM) of hens eggs which were brooded for 9 days. The time-dependent occurrence of different reaction types (haemorrhage, lysis, coagulation, e.g.) is documented over a time period of 5 minutes. The occurrence of reactions correlates with the intensity of the irritant potential. Execution of the Test:For Liquids, water soluble and transparent test items the Reaction Time Method (RTM) is used. - 4 eggs for the test item and 2 eggs for each positive control are used.- About 300 μL of the test item resp. the positive controls is applied on the focused part of the CAM, the stop watch is started the same moment- The CAM is observed continuously for 5 minutes and the moments (seconds after application) of occurrence of the different reaction types are documented- After finishing the experiment the eggs are put on dry ice as fast as possible to mortify the embryosCalculation of the Irritation Score (IS):Basis for the Irritation Score (IS) are the points of time where the reaction types haemorrhage, lysis and coagulation occurred.0 ≤ IS ≤ 0.09= not irritant1 ≤ IS ≤ 4.9= slightly irritant5 ≤ IS ≤ 8.9= moderate irritant9 ≤ IS ≤ 21= severe irritant

Results and discussion

In vivo

Results

Irritation parameter:

other: Irritation Score (IS)

Basis:

mean

Time point:

other: 5 minutes

Score:

0

Max. score:

21

Irritant / corrosive response data:

The test item “Triglycerides, C12-24, saturated and unsaturated, oxidized” is considered to be not irritant.

Any other information on results incl. tables

Table 1: results of controls:

Contact time	Description	Irritaion Score (IS)       (control 1 / control 2)	Haemorrhage       [sec.] (control1 / control 2)	Lysis       [sec.] (control 1 / control 2)	Coagulation IntraVascular     [sec.] (control 1 / control 2)	Coagulation Extravasc. Cloudiness   [sec.] (control 1 / control 2)
5 min	0,5 %  Texapon	9.82 / 10.06	70 / 70	45 / 35
5 min	1 %     Texapon	10.67 / 10.34	40 / 60	30 / 30
5 min	5 %     Texapon	10.62 / 11.33	22 / 15	45 / 20
5 min	0,3 %  Acetic Acid	8.58 / 8.73			32 / 26	15 / 10
5 min	3 %     Acetic Acid	8.79 / 8.73			10 / 10	8 / 10
5 min	30 %   Acetic Acid	8.97 / 8.94			2 / 3	4 / 5

Table 2: results of test item:

			Description Test Item			Remarks	Irritation Score IS / Points	Mean IS / Points	Result
Internal Egg No.	RTM	EPA	Haemorrhage     [sec]	Lysis     [sec]	Coagulation Extra-/Intravascul. or cloudiness [sec.]
A	X	/	-	-	-	-	0	0	not irritant
B	X	/	-	-	-	-	0
C	X	/	-	-	-	-	0
D	X	/	-	-	-	-	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

The test item “Triglycerides, C12-24, even, saturated and unsaturated, oxidized” is considered to be not irritant.

Executive summary:

The test item “Triglycerides, C12-24, even, saturated and unsaturated, oxidized” was tested in the HET-CAM-Testaccording to Spielmann, H. et al. (1997) CAM-based Assays. Food and Chemical Toxicology 35, 39-66. According to the definition of the Test the test item is considered to be as not irritant.