Lithium neodecanoate

Endpoint summary

Description of key information

No acute toxicity studies with lithium neodecanoate are available, thus the acute toxicity will be addressed with existing data on the dissociation products lithium and neodecanoic acid. The LD50 value for the moiety neodecanoic acid was shown to be greater than 2000 mg/kg bw in experimental testing. Three studies with the moiety lithium are available. All studies available were used in a weight of evidence approach and the oral LD50 value was calculated to be about 525 mg/kg bw corresponding to 98.65 mg Li/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

No acute toxicity studies with lithium neodecanoate are available, thus the acute toxicity will be addressed with existing data on the dissociation products lithium and neodecanoic acid.

Lithium

Acute oral toxicity

According to handbook data, the LD50 of lithium carbonate is 723 +/- 38 mg/kg bw after oral administration to female rats and 640 +/- 30 mg/kg bw to male rats and according to a review article, the LD50 of lithium carbonate is 525 mg/kg bw after oral administration to rats. Thus, even when considering the lower study result, the substance has to be classified as cat 4, H302 (harmful if swallowed) according to Regulation (EC) No 1272/2008.

Acute inhalation toxicity

It could be shown in two inhalation studies, performed with the maximal attainable concentrations of 0.80 mg/L that the LC50 is higher than 0.80 mg/L and estimated to be higher than 2 mg/L. In conclusion, the LC50 (inhalation, rat) of lithium carbonate is equal or higher than 2.0 mg/L and the substance is therefore not to be classified according to Regulation (EC) No 1272/2008 (CLP).

Acute dermal toxicity

A LD50 value of greater than 3000 mg/kg bw and LD0 value of 2000 mg/kg bw were determined in an acute dermal study that examined lithium carbonate in doses of 2000 mg/kg bw and 3000 mg/kg bw. In two additional acute dermal studies performed as limit tests a LD50 value of > 2000 mg/kg bw was determined. Thus, in conclusion, the LD50 (dermal rat) of lithium carbonate is greater than 3000 mg/kg bw and the substance is not to be classified according to Regulation (EC) No 1272/2008 (CLP).

Neodecanoic acid

Neodecanoic acid has a low potential for toxicity via the oral, inhalation, and dermal routes. 

Acute oral toxicity

Male and female rats were gavaged with neodecanoic acid at concentrations of 1, 1.5, 2, 3, or 4 ml/kg to assess acute oral toxicity.  All animals that died during the study did so within 3 days of exposure. Signs of toxicity included lethargy, hypothermia, piloerection, dyspnea, and ataxia. Based on these results, it is concluded that the LD50 is approximately 2.27 ml/kg (2066 mg/kg). 

 

Lithium neodecanoate

The moiety neodecanoic acid has not shown signs of acute oral toxicity in experimental testing (LD50 > 2000mg/kg). Three studies with the moiety lithium are available. All studies available were used in a weight of evidence approach and the oral LD50 value for lithium carbonate was calculated to be about 525 mg/kg bw.

Based on the assumption that lithium is the moiety of concern and responsible for adverse effects observed, an LD50 value for lithium of about 98.65 mg/kg bw could be calculated based on the molecular weight.

Under the assumption that the moieties of lithium neodecanoic show their toxicological profile individually upon dissolution, the acute oral toxicity of lithium neodecanoate can be calculated using the equation given in regulation (EC) 1272/2008, Annex I, Section 3.1.3.6.1.

The calculated oral LD50 for lithium neodecanoate is > 2000mg/kg based on stochiometric lithium content of 4.9 %, hence the substance is not to be classified according to regulation (EC) 1272/2008 for acute oral toxicity.

The calculated oral LD50 for lithium neodecanoate is 300 < LD50 <= 2000 based on the highest lithium content of 6.4 % (overbased product), thus the substance is classified according to regulation (EC) 1272/2008 for acute oral toxicity category 4 (H302: Harmful if swallowed). Due to the differences in classification and labelling for lithium neodecanoate based on the lithium content, two GHS profiles were created. However, the risk assessment was performed by using the worst-case scenario and assuming the highest lithium content of 6.4 % (overbased prorduct).

The calculated dermal LD50 for lithium neodecanoate is > 2000mg/kg, hence the substance is not to be classified according to regulation (EC) 1272/2008 for acute dermal toxicity.

For further information on the toxicity of the assessment entities, please refer to the relevant sections in the IUCLID and CSR.

Justification for classification or non-classification

The calculated oral LD50 for lithium neodecanoate is > 2000mg/kg based on stochiometric lithium content of 4.9 %, hence the substance is not to be classified according to regulation (EC) 1272/2008 for acute oral toxicity.

The calculated oral LD50 for lithium neodecanoate is 300 < LD50 <= 2000 based on the highest lithium content of 6.4 % (overbased product), thus the substance is classified according to regulation (EC) 1272/2008 for acute oral toxicity category 4 (H302: Harmful if swallowed). Due to the differences in classification and labelling for lithium neodecanoate based on the lithium content, two GHS profiles were created. However, the risk assessment was performed by using the worst-case scenario and assuming the highest lithium content of 6.4 % (overbased prorduct).

The calculated dermal LD50 for lithium neodecanoate is > 2000mg/kg, hence the substance is not to be classified according to regulation (EC) 1272/2008 for acute dermal toxicity.