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Description of key information

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

Signs of acute oral or acute dermal toxicity are not expected for zinc neodecanoate basic, since the assessment entity zinc has not shown signs of acute oral toxicity (LD50 > 2000mg/kg) and acute dermal toxicity is considered to be low in view of the poor absorption by this route. The assessment entity neodecanoate has not shown signs of acute oral or acute dermal toxicity in experimental testing (LD50 > 2000mg/kg).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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

Zinc

Acute oral toxicity

With LD50 values consistently exceeding 2,000 mg/kg bw, zinc oxide (LD50ranges between 5,000 and 15,000mg/kg bw), shows very low level of acute oral toxicity.

Acute inhalation toxicity

Key study carried out according to OECD guideline no 403 indicating for micro zinc oxide LC50 > 5.7 mg/L/4hrs

Acute dermal toxicity

There are no available data on which to evaluate acute dermal toxicity for ZnO micromaterial. However, acute dermal toxicity can be considered to be low taking into account the poor percutaneous absorption of zinc oxide or the zinc cation.

Neodecanoate

 

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

 

Oral

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). 

 

Dermal

In a study that assessed acute dermal toxicity, male and female rats were exposed to 4 ml/kg (3640 mg/kg) neodecanoic acid via an occluded dermal patch for 24 hours. After 24 hours, the patch was removed and clinical observations were made once daily for 9 days. There were no deaths observed in this study and there were no signs of a toxicity response.  It is concluded that the LD50 is greater than 3640 mg/kg. 

 

 

Zinc neodecanoate basic

Signs of acute oral or acute dermal toxicity are not expected for zinc neodecanoate basic, since the moiety zinc has not shown signs of acute oral toxicity (LD50 > 2000mg/kg) and acute dermal toxicity is considered to be low in view of the poor absorption by this route. The moiety neodecanoate has not shown signs of acute oral or acute dermal toxicity in experimental testing (LD50 > 2000mg/kg).

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

A study for acute toxicity via inhalation was not conducted with zinc neodecanoate basic, since it is produced and placed on the market in a form in which no inhalation hazard is anticipated, thus acute toxic effects are not likely to occur during manufacture and handling of that substance. For further information on the toxicity of the individual moieties, please refer to the relevant sections in the IUCLID and CSR.

Justification for classification or non-classification

Based on in vivo oral and dermal LD50 data on the assessment entities, acute toxicity estimates for zinc neodecanoate basic have been calculated resulting in LD50 values > 2000 mg/kg bw.

According to the criteria of REGULATION (EC) No 1272/2008 and its subsequent adaptions, zinc neodecanoate basic does neither have to be classified and has no obligatory labelling requirement for acute oral or dermal toxicity nor for specific target organ toxicity after single exposure (STOT SE).

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