Golden Yellow Continuous

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8 to 11 June 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Compliant to OECD 405 and GLP guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Details on test material:

Name: Golden Yellow Continuous

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Sándor Ferenc, 2173 Kartal, Császár út 135, HUNGARY
- Age at study initiation: 9 weeks
- Weight at study initiation: 3624 to 3859 g
- Housing: single
- Diet: PURINA Base – Lap gr. diet for rabbits ad libitum
- Water: tap water ad libitum
- Acclimation period: 40 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.7-23.2
- Humidity (%): 30-69
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 8 to 11 June 2009

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

1 hour

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline solution
- Time after start of exposure: 1 hour


SCORING SYSTEM:
1, 24, 48, and 72 hours, then at 1 week post treatment

1. Conjunctivae

A. Redness (Palpebral and bulbar)
Normal 0
Some blood vessels hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse beefy red 3

B. Chemosis
Normal 0
Some swelling above normal (includes nictating membrane) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4

C. Discharge
No discharge 0
Any amount different from normal (does not include small amounts
observed in inner canthus of normal animals) 1
Discharge with moistening of the lids and hairs just adjacent to lids 2
Discharge with moistening of the lids and hairs, on considerable area
around the eye 3


2. Iris

D. Values
Normal 0
Markedly deepened rugae, congestion, swelling, moderate
circumcorneal hyperaemia: or injection: iris reactive to light
(a sluggish reaction is considered to be an effect) 1
Haemorrhage, gross destruction, or no reaction to light. 2



3. Cornea

E. Opacity-degree of density (Area most dense taken for reading)
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight
dulling of normal lustre): details of iris clearly visible 1
Easily discernible translucent area: details of iris slightly obscured 2
Nacrous area: no details of iris visible: size of pupil barely discernible 3
Opaque cornea: iris not discernible through the opacity 4

F. Area of cornea involved
One quarter (or less), but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4



Irreversible effects on the eye/serious damage to eyes (Category 1)
If, when applied to the eye of an animal, a substance produces:
— at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days;
and/or
— at least in 2 of 3 tested animals, a positive response of:
o corneal opacity ≥ 3 and/or
o iritis > 1,5
calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.


Reversible effects on the eye/irritating to eyes (Category 2)
If, when applied to the eye of an animal, a substance produces:
— at least in 2 of 3 tested animals, a positive response of:
o corneal opacity ≥ 1 and/or
o iritis ≥ 1, and/or
o conjunctival redness ≥ 2 and/or
o conjunctival oedema (chemosis) ≥ 2
o calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

1, 2, 3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

1, 2, 3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

1, 2, 3

Time point:

other: 24, 48 and 72 hours

Score:

0.33 - 1

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

other: redness

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

1, 2, 3

Time point:

other: 24 to 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

No abnormalities were detected in the control eyes during the entire study period.
Initial Pain reaction (score 1) was observed in all animals. All animals blinked several times in response to instillation of the test item.
One hour after the application, conjunctival redness (score 2) was observed in two animals, conjunctival redness (score 1) in one animal, discharge (score 2) was found in two animals, and discharge (score 1) in case of one animal.
At 24 hours after treatment, conjunctival redness (score 2) was observed in two animals, conjunctival redness (score 1) in one animal.
At 48 hours after treatment, conjunctival redness (score 1) was found in two animals.
At 72 hours after treatment, there were no signs of eye irritancy observed.

Any other information on results incl. tables

INDIVIDUAL SCORES FOR OCULAR IRRITATION

Time	Animal No.	Score of irritation								IPR
		Conjunctivae			Opacity of cornea		Iris	Control eye	Other sign
		R	CH	D	OD	OE	R
1 hour	04080	2	0	2	0	0	0	0	-	1
	04084	1	0	1	0	0	0	0	-	1
	04028	2	0	2	0	0	0	0	-	1
24 hours	04080	2	0	0	0	0	0	0	-
	04084	1	0	0	0	0	0	0	-
	04028	2	0	0	0	0	0	0	-
48 hours	04080	1	0	0	0	0	0	0	-
	04084	0	0	0	0	0	0	0	-
	04028	1	0	0	0	0	0	0	-
72 hours	04080	0	0	0	0	0	0	0	-
	04084	0	0	0	0	0	0	0	-
	04028	0	0	0	0	0	0	0	-

R = Redness; OD = Opacity degree of density; CH = Chemosis; OE = Extension of opaque area; D = Discharge; IPR = Initial pain reaction; - = No clinical signs

BODY WEIGHT DATA

Animal Number	Beginning of study (g)	At the end of study (g)	Body weight gain (g)
04080	3814	3853	39
04084	3624	3725	101
04028	3859	3952	93

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In conclusion, according to Regulation (EC) No 1272/2008, Golden Yellow Continuous does not require classification as an eye irritant.

Executive summary:

An acute eye irritation study of the test item Golden Yellow Continuous was performed in New Zealand White rabbits. The irritation effects of the test item were evaluated according to the Draize method (OECD No.: 405, 2002).

The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. An amount ofof the solid test item was administered as a single dose. The eyes of the test animals were rinsed with 0.9% NaCl solution, one hour after application of the test item.

The eyes were examined at 1, 24, 48 and 72 hours after the application.

 

Initial Pain reaction (score 1) was observed in all animals. All animals blinked several times in response to instillation of the test item.

One hour after the application, conjunctival redness (score 2) was observed in two animals, conjunctival redness (score 1) in one animal, discharge (score 2) was found in two animals, and discharge (score 1) in case of one animal.

At 24 hours after treatment, conjunctival redness (score 2) was observed in two animals, conjunctival redness (score 1) in one animal.

At 48 hours after treatment, conjunctival redness (score 1) was found in two animals.

At 72 hours after treatment, there were no signs of eye irritation observed.

As there were no local or systemic clinical signs observed 72 hours after test item administration, the study was terminated after the 72-hour observation.

No abnormalities were detected in the control eyes during the entire study period.

 

The general state and behaviour of animals were normal throughout the study period. There were no notable body weight changes during the study period.

The animal’s individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:

Animal Number	Cornea Opacity	Iris	Conjunctivae
			Redness	Chemosis	Discharge
04080	0.00	0.00	1.0	0.00	0.00
04084	0.00	0.00	0.33	0.00	0.00
04028	0.00	0.00	1.0	0.00	0.00

 

The test item Golden Yellow Continuous, applied to the rabbits eye mucosa, caused significant conjunctival irritant effects at one hour which were reduced 24 hours after application. The effects were fully reversible within 72 hours.

According to Regulation (EC) No 1272/2008, Golden Yellow Continuous does not require classification as an eye irritant.