N-alkylester N-aryl substituted aryl diazo aryl amine

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 DYNS 2246 was performed in three 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).

The test item was administered undiluted, as a single dose of , to the hairless skin of all experimental rabbits with moistening by approximately 1 ml of water. 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 changes related to DYNS 2246 administration.

There was no effect of treatment on body weight.

At observation one hour after patch removal, very slight erythema (score 1) was observed in all three animals and very slight oedema (score 1) was observed in one animal.

At 24 hours after patch removal, very slight erythema (score 1) was noted in one animal.

At 48 and 72 hours after patch removal, there were no signs observed on the skin of the treated animals.

As no clinical signs were observed up to 72 hours after patch removal, the study was terminated after the 72 hours observation.

The animals' individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema were 0.00, 0.00 and 0.33 respectively.

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

According to Directive Regulation (EC) No 1272/2008, DYNS 2246 does not require classification as a skin irritant.

According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, DYNS 2246 does not require classification as a skin irritant.

An acute eye irritation study of the test item DYNS 2246 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. A weight of 0.1 g of the test item was used for the study as supplied and was administered as a single dose. The treated eye was rinsed with physiological saline solution at the 1 hour post treatment observation.

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

One hour after the single application of test item DYNS 2246 into the eye of the rabbits, conjunctival redness and discharge was observed in all animals and chemosis was found in two animals.

At 24, 48 and 72 hours after treatment conjunctival redness was observed in all animals.

The study was terminated at one week post treatment. At this time no abnormalities were detected in the test item treated eyes.

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

There was no mortality or systemic clinical signs related to DYNS 2246 administration observed at the general examination performed daily.

Development of body weight, determined at study termination, was not affected by the conjunctival application of DYNS 2246 when compared to pre-treatment values.

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

Conjunctivae			Iris	Cornea opacity
Redness	Chemosis	Discharge
1.33	0	0	0	0
2.00	0	0	0	0
1.33	0	0	0	0

In conclusion, according to the Regulation (EC) No 1272/2008, DYNS 2246 does not require classification as an eye irritant.