Lithium Nickel Cobalt Aluminium Oxide

Endpoint summary

Description of key information

The acute oral median lethal dose (LD50) of the test material in the female Sprague Dawley CD strain rat (Sanders, 2008)was estimated to be greater than 2000 mg/kg bodyweight, resulting in a no-classification for this endpoint.

The theoretically derived classification with MeClas resulted in a more stringent Cat.4 classification wor the worst-case composition, and this classification was determined by the presence of CoO (Co: 12%). The test that was conducted by Sanders (2008) used an NCA-sample that had a Co-concentration (11.2%) that was similar to that of the worst-case composition, and that was markedly higher than the typical Co-concentration of NCA (5.15%)

An acute inhalation study was performed by Toda (2014), using male/female Wistar rats. No mortality was observed at 0.05 mg/L (upper threshold value for Cat.1 -classification), but 90% mortality was observed at a concentration of 0.23 mg/L. A Cat.2 classification is allocated for substances with an LC50 between 0.05 and 0.5 mg/L.  

The theoretically derived classification with MeClas confirmed this classification.

No adverse effects were observed in a dermal toxicity test with male/female Wistar rats, resulting in a no-classification for this endpoint.

The theoretically derived classification with MeClas confirmed this no-classification.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Quality of whole database:

The key study was conducted in accordance with the standardised OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method) and Method B1 bis Acute Toxicity (Oral) of Commission Directive 2004/73/EC.
The study complied with GLP and was awarded a reliability score of 1 in accordance with the principles laid out by Klimisch (1997).

Acute toxicity: via inhalation route

Endpoint conclusion

Quality of whole database:

The key study was conducted in accordance with the standardised OECD Guideline 403 (Acute Inhalation Toxicity) and EU Method B.2 (Acute Toxicity (Inhalation))
The study complied with GLP and was awarded a reliability score of 1 in accordance with the principles laid out by Klimisch (1997).

Acute toxicity: via dermal route

Endpoint conclusion

Quality of whole database:

The key study was conducted in accordance with the standardised OECD Guideline 402 (Acute Dermal Toxicity) and EPA OPPTS 870.1200 (Acute Dermal Toxicity)
The study complied with GLP and was awarded a reliability score of 1 in accordance with the principles laid out by Klimisch (1997).

Additional information

The acute oral toxicity of the test material was assessed in females of the Sprague‑Dawley CD strain rat. The method was designed to meet the requirements of the following standardised guidelines: OECD Guidelines for Testing of Chemicals No 420 “Acute Oral Toxicity - Fixed Dose Method” (2001) and Method B1bisAcute Toxicity (Oral) of Commission Directive 2004/73/EC.

Following a sighting test at dose levels of 300 mg/kg and 2000 mg/kg, a further group of four fasted females was given a single oral dose of test material, as a suspension in arachis oil BP, at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

 

There were no deaths in the study and no signs of systemic toxicity.

All animals showed expected gains in bodyweight.

No abnormalities were noted at necropsy of animals treated at a dose level of 2000mg/kg bodyweight.

 

The acute oral median lethal dose (LD₅₀) of the test material in the female Sprague‑Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight.

Justification for selection of acute toxicity – oral endpoint
Only one study available.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for acute oral toxicity, as dosing at the limit for the route of exposure failed to induce any toxic effects.

In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material required a Cat.2 classification for acute inhalation toxicity, as dosing at the lower limit for the Cat.2 inhalation exposure route failed to induce any toxic effects, but dosing at the higher limit for the Cat.2 inhalation exposure route caused 90% mortality.

In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for acute dermal toxicity, as dosing at the limit for the route of exposure failed to induce any toxic effects.