Golden Yellow Continuous

Endpoint summary

Description of key information

Not irritating to skin or eyes

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

An acute skin irritation study of the test item Golden Yellow Continuous was performed in New Zealand White rabbits. Parameters monitored during this study included mortality, body weight measurements and clinical observations. The irritation effects of the test item were evaluated according to the Draize method (OECD No.: 404, 2002).

An amount of 0.5 g of the solid test item was applied neat to the skin of the experimental animals. The test item was applied as a single dose. Sufficient water to damp the material was used to ensure good contact with the skin and an adhesive clear plastic patch was applied. The trunk was wrapped in a semi-occlusive clear plastic film with medical tubing used to hold the patch in place. The untreated skin of each animal served as control.

After 4 hours, the remaining test item was removed with water of body temperature.

To assess skin irritation, animals were examined at 1, 24, 48 and 72 hours after the patch removal. Additional general examinations were performed daily.

 

There was no mortality or systemic clinical change related to Golden Yellow Continuous administration.

There was no effect of treatment on body weight.

At observation one and 24 hours after patch removal, very slight erythema (score 1) was found at the application site in all animals.

At 48 and 72 hours after patch removal, there were no signs of skin irritation observed.

As no systemic or local clinical signs were observed at 72 hours after patch removal, the study was terminated after the 72-hour observation.

 

The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema were 0.33 at all time points.

The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for oedema were 0.00 at all time points.

 

According to Directive 2001/59/EC and Regulation (EC) No 1272/2008, Golden Yellow Continuous does not require classification as a skin irritant.

According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, Golden Yellow Continuous does not require classification as a skin irritant.

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.