Registration Dossier

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Administrative data

Description of key information

In accordance with column 2 of REACH Regulation 1907/2006/EC Annex VII section 8.1, 8.2  and in line with animal welfare reasons skin and eye irritation / corrosion studies should not be performed due to the known corrosive characteristic of lithium metal (Cat. 1B (H314) /  R34).

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

skin irritation

When lithium comes in contact with water or moist skin, lithium hydroxide is formed, responsible for lithium metal corrosivity. Thus, in accordance with column 2 of REACH Regulation 1907/2006/EC Annex VII section 8.1 and in line with animal welfare reasons, a skin irritation / corrosion study does not need to be performed as lithium is known to be corrosive and classified as corrosive to the skin according to Regulation (EC) No 1272/2008 CLP (Cat. 1B, H314) and according to Directive 67/548/EEC (R34). An available corrositex study (FMC, 2009, Report No. 100609A/B) performed with lithium hydroxide, showing a corrosive effect by lithium hydroxide, supports the waiving of the study performance.

eye irritation

In accordance with column 2 of REACH Regulation 1907/2006/EC Annex VII section 8.2 and in line with animal welfare reasons an in vivo / in vitro study for eye irritation / corrosion does not need to be conducted as the critera are met for classification of lithium as corrosive to skin and eye: "causes severe skin burns and eye damage" (Cat. 1B (H314) according to Regulation (EC) No 1272/2008 (CLP) and Corrosive R34 according to Directive 67/548/EEC).


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 toxicity, the test item is classified as corrosive, cat 1B (H314) according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.

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