Registration Dossier

Administrative data

Description of key information

The skin irritation potential of the test substance Dusatnox L was evaluated in skin irritation study with 3 New Zeland White rabbits according to the GLP and OECD 404. 
The eye irritation potential of the test substance Dusatnox L was evaluated in eye irritation study with 3 New Zeland White rabbits according to the GLP and OECD 405.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

The skin irritation potential of the test substance Dusatnox L was evaluated in skin irritation study with 3 New Zeland White rabbits according to the GLP and OECD 404. Sample amount was 0.5 ml. Exposure time was 4 hours, observation period after 1, 24, 48, and 72 hours.

In 1 hour after application very mild repletion without oedema was found out at the 1st animal, in 24 hours after

application no changes were found out. In 48 and 72 hours after application the mild repletion without oedema was

found out. On the 5th day after application the increased separating of skin surface coats, the mild repletion without

oedema were found out. On the next days the repletion became milder, the reaction was quite lost on the 9th day

after application.

In 1 hour after application the very mild repletion without oedema was found out at the 2nd and the 3rd animal, in 24

hours no changes were found out, in 48 hours the very mild repletion was found out and in 72 hours after

application the mild repletion and very mild oedema were found out. On the 4th and the 5th day - mild repletion

without oedema, on the 6th day - mild repletion and separating of skin surface coats without oedema. After 10th

day at the 2nd animal and after 14th day at the 3rd animal their skin was quite healed without the changes.

Changes fully reversible within 14 days Irritation Index: 1,16

The test shows the substance has the light irritant effects on the skin .

The eye irritation potential of the test substance Dusatnox L was evaluated in eye irritation study with 3 New Zeland White rabbits according to the GLP and OECD 405. Sample amount of 0.1 ml was applied into the conjuntival sac of the rabbits . Exposure time was 4 hours.

The clinical eye examination was carried out in the periods in 1, 24, 48 and 72 hours after application of the sample. In 1 hour after application the eye reactions were considered without the flush of the eye with water. In 24 hours the assessment was carried out after wary flush of the eye with water. The examination of the cornea mesh defect was carried out after decolouration with fluorescein. The reaction after 72 hours after application was assessed by using of fluorescein. Results: In 1 hour after exposure a slight redness was observed at the first and third animals and slight ophthalmorrhoea was was observed at first animal. No observable changes was noted during the observation period - in 24, 48 and 72 hours after application of the sample among all animals.

Changes fully reversible within 1 day.

Acute Eye Irritation Index: 4.


Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

No classification is required according to the classification criteria 67/548/EEC and regulation No. 1272/2008 (GHS, CLP).