Registration Dossier
Registration Dossier
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EC number: 283-563-7 | CAS number: 84682-03-1
Endpoint summary
Administrative data
Description of key information
No acute toxicity studies with zinc bis(3,5,5-trimethylhexanoate) are available, thus the acute toxicity will be addressed with existing data on the dissociation products zinc and 3,5,5-trimethylhexanoic acid. According to the read-across assessment framework (RAAF), neodecanoic acid will be considered in place of 3,5,5-trimethylhexanoic acid.
Signs of acute oral or acute dermal toxicity are not expected for zinc bis(3,5,5-trimethylhexanoate), 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. Neodecanoic acid, as representative of 3,5,5-trimethylhexanoic acid, 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
No acute toxicity studies with zinc bis(3,5,5-trimethylhexanoate) are available, thus the acute toxicity will be addressed with existing data on the dissociation products zinc and 3,5,5-trimethylhexanoic acid. According to the RAAF, neodecanoic acid will be considered as representative of 3,5,5-trimethylhexanoic acid.
Zinc
Acute oral toxicity
- With LD50values consistently exceeding 2,000 mg/kg bw, zinc oxide (LD50ranges between 5,000 and 15,000 mg/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.
Neodecanoic acid
Neodecanoic acid has a low potential for toxicity via the oral 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).
Acute dermal toxicity
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 bis(3,5,5-trimethylhexanoate)
Signs of acute oral or acute dermal toxicity are not expected for zinc bis(3,5,5-trimethylhexanoate), 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. Further, neodecanoate, as representative of 3,5,5-trimethylhexanoic acid, 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 bis(3,5,5-trimethylhexanoate) show their toxicological profile individually upon dissolution, the acute oral and dermal (systemic) toxicity of zinc bis(3,5,5-trimethylhexanoate) 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 bis(3,5,5-trimethylhexanoate), 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 moieties, acute toxicity estimates for zinc bis(3,5,5-trimethylhexanoate) 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 bis(3,5,5-trimethylhexanoate) does not have to be classified and has no obligatory labelling requirement for acute oral or dermal toxicity.
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