Registration Dossier

Administrative data

Description of key information

The test item did not reveal any irritating effects on the skin or the eyes of test animals.

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

In vivo

Test material was subject to an acute dermal irritation /corrosion test in 6 male New Zealand rabbits according to EU method B.4 (Clariant, 1794TAL, 1985). After the 4 h exposure to 0.5 mL of the undiluted test material under semi-occlusive conditions no skin effects were visible (erythema scores and edema scores: 0, in all animals at any time). Therefore the test item is not a skin irritant.

Additionally, an in vivo skin irritation test conducted with Vienna White rabbits according to OECD guideline 404 is available (BASF, 18A1019/882387, 1989). The rabbits were exposed to the undiluted test substance for 4 hours under semi-occlusive conditions. No skin effects were visible after 72 hours. This, the test substance is not considered to be irritating to the skin.

In vitro

In an in vitro skin irritation test according to OECD draft guideline in compliance with GLP (EpiDerm Test) the test substance did not show a skin irritation potential (BASF, 61H0300/092076, 2010). According to the results from an in vivo skin irritation test in rabbits the test substance is considered to be not irritating to the skin (BASF, 1989).

 

Eye irritation:

Two eye irritation studies with New Zealand White rabbits are available. In the key study from 2010 (BASF, 11H0300/092077), 0.1 mL of the unchanged substance was instilled into the conjunctival sac of 3 animals for 24 h. The animals then were observed for 72 days. After 72 hours no eye irritation was observed. Thus, the test substance is not considered to be irritating to the eye.

In another study with New Zealand White rabbits from 1985 (Clariant, 1794TAL) the test substance was also not irritating to the eye. One hour after the instillation of 0.1 mL of the undiluted test material into the lower left conjunctival sac of each rabbit there were slightly irritating effects seen (conjunctival redness score 1 to 2 in 6/6 animals; chemosis score 1 in 4/6 animals). These effects were all reversible within one day as there were no more effects on the eyes visible at the 24 h reading.

These results are supported by an eye irritation study with Vienna White rabbits, conducted with a test substance of lower analytical purity (74%; BASF, 11H1019/882388, 1989).

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin and eye irritation/corrosion, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.