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

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Remarks:

in vivo test

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-10-05 to 2012-11-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been performed according to OECD guideline 405 and EU method B.5 in a GLP-certified testing facility.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

other: liquid

Details on test material:

Sponsor' s identification: 400112
Date received: 24 September 2012
Container: brown glass flask (n=l)
Quantity: 93.15 g (container + contents)
Batch No: 0001273679
Colour: yellow-brown
Storage: room temperature
Production date: May 2011
Expiry date: May 2013
Purity: 100% (not purified but used as synthesized)
Composition: UVCB substance
It was identified under the code number: PH-12/0481

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

One male albino New Zealand rabbit was supplied by the Elevage de Gérome (Quartier Labaste -F40260 Linxe).
Acclimatisation period: minimal 5-days
Age at the beginning of the test: 14 weeks
Body weight during the test: between 2.89 kg and 3.12 kg.
The animal was identified prior to inclusion in the test by means of a numbered ring on the edge of
one ear.
Housing: individual box installed in conventional air conditioned animal husbanding:
Temperature: 17 to 23°C
Relative humidity: 30 to 70%
Rate of air exchange: approximately between 10-15 changes per hour
Lighting: 12 h continuous light (07.00 to 19.00) and 12 h darkness.
Drinking water (tap-water from public distribution system) and foodstuff (SAFE- 112) were supplied freely.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the other eye of of the animal remained untreated serving as control

Amount / concentration applied:

0.1 mL of test item was used, as supplied.

Duration of treatment / exposure:

3 days

Observation period (in vivo):

3 days

Number of animals or in vitro replicates:

1

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean of scores at examinations after 1 h, 48 h and 72 h

Score:

3.7

Max. score:

4

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean of scores at examinations after 1 h, 48 h and 72 h

Score:

2

Max. score:

2

Remarks on result:

other: examination of "redness"

Results 3

Irritation parameter:

iris score

Remarks on result:

other: The iris was not visible between day 0 (1 hour after instillation) and day 3.

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: mean of scores at examinations after 1 h, 48 h and 72 h

Score:

4

Max. score:

4

Other effects:

White secretions requiring a physiological rinse was noted on days 2 and 3.
A brown coloration of the nictitating membrane was noted 1 hour after the test item application.
For ethical reasons, the animal was euthanized on day 3.

Any other information on results incl. tables

Animal n°	Time aftertreatment	CONJUNCTIVAE		IRIS	CORNEA
		CHEMOSIS	REDNESS	LESION	OPACITY
A2405	24h	3	2		4
	48h	4	2		4
	72h	4	2		4
TOTAL		11	6		12
Mean		3.7	2.0		4.0

Applicant's summary and conclusion

Interpretation of results:

other: Category 1, causes serious eye damage according to EU regulation

Conclusions:

Based on the results of this in vivo test the test item 400112 must be classified according to Regulation (EC) No. 1272/2008 in category 1 "serious eye damage".

Executive summary:

The test item 400112 was instilled as supplied, into the eye of one New Zealand rabbit at the dose of 0.1 mL. The experimental protocol was established on the basis of the official method as defined in the OECD guideline No. 405 dated April 24^th, 2002 and the test method B.5 of the council regulation No. 440/2008.

The ocular reactions observed during the study have been moderate to severe and were not reversible.

For ethical reasons, the animal was euthanized on day 3.

In accordance with the Regulation (EC) No. 1272/2008, the test item must be classified in category 1 "causes serious eye damage".