Registration Dossier

Administrative data

Description of key information

Based on the findings of this OECD 404 study in New Zealand White rabbits with 4h semi occlusive skin treatment, observed over a period of 7 days, test substance is determined to be skin irritant. 
Based on the findings of this OECD 405 study in New Zealand White rabbits, the test substance is determined to be highly eye irritant.

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

Twenty four hours prior to treatment, 25cm2of the dorsal skin was shaved. Only animals with intact skin were used. A plaster containing a cellulose layer of 2.5 x 2.5 cm was fixed on the prepared skin area of each animal. Under this plaster 0.5 mL of the undiluted test item was applied. The area was then fixed by a semi occlusive bandage for a period of 4 hours. At the end of treatment time the remaining residues were carefully deleted from skin with lukewarm water. The assessment was performed 30-60 minutes, 24, 48 and 72 hours after removing of bandage. Due to some findings still available after 72 hours, the observation period was expanded to 7 days for another evaluation. The skin was assessed for erythema-, eschar-formation and edema according to Draize. All other skin changes were noted.30-60 minutes, 24, 48 and 72 hours after removing of the plaster, slight to mild erythema and slight edema were observed at all animals.The skin appears partly dry, rough and kind of flaky during the observation period.The overall scoring value is 2.3 for erythema-, eschar-formation and 0.5 for edema formation. All findings were reversible within seven days after removal of plaster.

Eye Irritation

In order to assess the eye irrtating potential of the test substance, 0.1 mL of the undiluted test item was applied into the conjunctival sac of the left eye of one rabbit. The untreated eye serves as control. 24 hours after treatment and at any time point when the cornea needs to be inspected with fluorescein-sodium solution, the eye was washed with physiological saline solution (Temperature about 37°C). The assessment was performed 60 minutes, 24, 48 and 72 hours after application of test item and additionally after 7 days due to some findings. At the 24 and 72 hour time point and after 7 days, additionally a drop of fluorescein-sodium solution was instilled and the eye was examined under UV-light. The eye reactions were assessedaccording to the numerical scoring system (acc. to Draize). The description of the degree and nature of irritation, the presence of serious lesions and non-occular effects were noted.

Until 72 hours after application the conjunctiva showed a crimson up to diffuse strong red color and an edema up to half eye-lid closure. The iris was reddened. The cornea showed diffuse to pearly-like opacity areas. Additional a clear-colorless or white to mucous effluent and bleeding of the nictitating membrane was observed. Seven days after the application of test item the conjunctiva showed still a diffuse crimson color and the cornea diffuse opacity areas. Additional an advanced vascularization was observed.


Justification for selection of skin irritation / corrosion endpoint:
only available study

Justification for selection of eye irritation endpoint:
only available study

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Classified as:

Skin irritation Cat 2: H 315 (causes skin irritation)

Eye damage Cat 1: H 318 (causes seirous eye damage)

Justification:

Based on the findings of this OECD 404 study in New Zealand White rabbits with 4h semi occlusive skin treatment, observed over a period of 7 days, test substance is determined to be skin irritant.

Based on the findings of this OECD 405 study in New Zealand White rabbits, the test substance is determined to be highly eye irritant.