Registration Dossier

Administrative data

Description of key information

No acute toxicity study with zinc m-toluate is available, thus the acute toxicity will be addressed with existing data on the individual moieties barium and m-toluate.

Signs of acute oral or acute dermal toxicity are not expected for zinc m-toluate, since for the moiety zinc, acute dermal toxicity is considered to be low in view of the poor absorption by this route and the moiety m-toluate 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 m-toluate

No acute toxicity studies with zinc m-toluate are available, thus the acute toxicity will be addressed with existing data on the individual moieties zinc and m-toluate.

Signs of acute oral or acute dermal toxicity are not expected for zinc m-toluate, since for the moiety zinc, acute dermal toxicity is considered to be low in view of the poor absorption by this route and the moiety m-toluate 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 m-toluate show their toxicological profile individually upon dissolution, the acute oral and dermal (systemic) toxicity of zinc m-toluate 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 m-toluate, 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.

 

The calculated oral and dermal LD50 for zinc m-toluate is > 2000mg/kg, hence the substance is not to be classified according to regulation (EC) 1272/2008 for acute oral and dermal toxicity.

 

Zinc

Acute oral toxicity

- With LD50values 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 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 in view of the poor absorption by this route.

 

m-toluate

Acute oral toxicity

One acute toxicity study in rats (key study) via the oral route with m-toluic acid is available, resulting in LD50 (oral, male and females rats) > 2000 mg/kg bw

According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route.

 

Acute dermal toxicity

The acute oral toxicity study with m-toluic acid did not show any signs of systemic toxicity upon administration up to the limit dose, indicating a very low systemic toxicity of that substance. The low systemic toxicity is corroborated by supporting evidence in an in vivo study, in which 6 japanese white rabbits were dermally exposed to the substance for 24 hours with a 7 day observation period. No mortality or other clinical signs of systemic toxicity were observed in animals. In accordance with Annex XI, Section 1.2 further testing is considered not to be required, since the overall weight of evidence in experimental animals exposed via dermal and oral route did not indicate any acute toxic effects. Experimental testing is therefore waived.

Justification for classification or non-classification

The calculated oral and dermal LD50 for zinc m-toluate is > 2000mg/kg, hence the substance is not to be classified according to regulation (EC) 1272/2008 for acute oral and dermal toxicity.