Registration Dossier

Administrative data

Description of key information

Based on available data on the read-across substances, the test item is also considered to be skin irritating and eye damaging, accordingly.

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 (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No experimental data on skin irritation /corrosion is available for the test item. However, experimental data for three source substances is available and a read-across approach is applied. Please refer to read-across justification document attached in IUCLID Section 13. Furthermore, only key studies of the source substances are taken into account. For further supporting information please refer to respective dossier of each source substance.

Source substance 1 (CAS121617 -08 -1):

In a primary dermal irritation study, New Zealand white rabbits were dermally exposed to 0.5 mL of 60% test item solution for 4 hours. Irritation was scored at 4, 24, 48 and 72 h post application. In this study, the solution is a dermal irritant. Given the results seen with a 60% mixture it is proposed to classify concentrations at greater than 60% as Corrosive category 1C.

Under the conditions of another study, the test material (50%) has been shown to be corrosive to the skin of rabbits. However, the validity of this result is considered ambiguous.

 

In a primary eye irritation study 0.1 mL of a 50 % solution was instilled into the conjunctival sac of the right eye of white rabbits (3/sex). The eyes were not washed after application of the test product. Animals then were observed for 21 days. Irritation was scored by the method of Draize. Unlike all the other endpoints, corneal opacity effects were not fully reversible within 21 days post-application for almost all the animals tested. This suggests that the substance may have caused permanent damage to the eye of the rabbit.

 

 

Source substance 2 (CAS 68411 -30 -3):

In a dermal irritation study three rabbits were exposed to 0.5 mL of the test substance dermally for 4 hrs. The test substance was covered with an occlusive dressing and removed by washing 4 hrs later. Animals were examined at 30 minutes after removal, and daily thereafter for 14 days. Irritation was noted in all animals at the first observation (maximum score of 2). Symptoms worsened, and desquamation, necrosis, and hyperkeratinization was noted by day 4. Symptoms resolved in one animal by day 12, but in the other two animals, symptoms were seen through the end of the observation period. The primary dermal irritation index was 2.17. The test substance is considered a Category 2 irritant according to EU GHS guidelines based on persistent irritation.

 

Source substance 3 (CAS 111 -42 -2):

A skin irritation study was conducted with Vienna white rabbits. Unchanged substance was applied to the shaved skin for 1, 5, and 15 minutes and 20 h of 2 animals, respectively. Animals were inspected 24, 48, 72 h and 8 d after treatment. No signs of irritation, such as edema or erythema were observed in animals that were exposed for 1 and 5 minutes, respectively. Exposure of 15 min exhibited erythema (score 1) in both animals 24 h after treatment, which was reversible after 48 hours. In both animals exposed to the substance for 20 hours edema score 2 and erythema score 3 were observed after 24 h and lasted 48 h or longer. All signs of dermal irritation were vanished 8 days after exposure.  

 

An eye irritation study equivalent to OECD 405 was conducted in Vienna white rabbits. 0.05 mL of the unchanged substance was applied into the conjunctival sac of the eye of two animals and was not washed out. Animals were observed 24, 48 and 72 hours and 8 days after treatment. Mean scores for each animal according to Draizé for 24 – 72 hours post exposure were 1.33 and 2 for cornea opacity, 2 and 1 for conjunctiva redness and 0.66 and 1 for chemosis, respectively. Additional findings were corrosions of conjunctiva and nictitating membrane visible, as well as mucosal bleeding. Symptoms were not fully reversible until day 8 after exposure.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data on three read-across substances are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Source substance 2 and 3 are main constituents of the test item and are both classified as skin irritating cat 2 and eye corrosive cat 1, respectively. Consequently, the test item is also classified for skin irritation cat 2 (H315: "Causes skin irritation") and eye corrosion (H318: "Causes serious eye damage") under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.