Registration Dossier

Administrative data

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 Triazin UV-Absorber 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 Triazin UV-Absorber administration. There was no effect of treatment on body weight.

During the observation at 1, 24, 48 and 72 hours after patch removal, there were no signs of skin irritation observed. The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema and oedema were 0.00 at all time points.

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

According to Directive 2001/59/EC and Regulation (EC) No 1272/2008, Triazin UV-Absorber does not require classification as a skin irritant. According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, Triazin UV-Absorber does not require classification as a skin irritant.

An acute eye irritation study with Triazin UV-Absorber 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 of 100 mg of 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.

 

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.

 

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) and discharge (score 2) was observed in all animals, and chemosis (score 1) was found in case of two animals.

At 24 hours after treatment, conjunctival redness (score 1) was observed in all animals.

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

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

 

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

04079

0.00

0.00

0.33

0.00

0.00

00012

0.00

0.00

0.67

0.00

0.00

04086

0.00

0.00

0.33

0.00

0.00

 

The test item Triazin UV-Absorber, applied to the rabbit 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 Directive 2001/59/EC and Regulation (EC) No 1272/2008, Triazin UV-Absorber does not require classification as an eye irritant. According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, Triazin UV-Absorber does not require classification as an eye irritant.

 

Justification for classification or non-classification

No classification necessary