Registration Dossier

Administrative data

Description of key information

No acute toxicity studies with zinc dioctanoate are available, thus the acute toxicity will be addressed with existing data on the dissociation products zinc and octanoic acid. Signs of acute oral toxicity are not expected for zinc dioctanoate, since for the moieties zinc and octanoate have not shown signs of acute oral toxicity (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 study available

Additional information

Zinc dioctanoate

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

Signs of acute oral toxicity are not expected for zinc dioctanoate, since for the moieties zinc and octanoate have not shown signs of acute oral toxicity (LD50 > 2000mg/kg). Under the assumption that the moieties of zinc dioctanoate show their toxicological profile individually upon dissolution, the acute oral (systemic) toxicity of zinc dioctanoate can be calculated using the equation given in regulation (EC) 1272/2008, Annex I, Section 3.1.3.6.1.

Further, in a supporting study with the analogous substance zinc dilaurate, no toxicity was seen in an acute inhalation toxicity test up to the limit concentration of 5mg/L. Thus, acute toxic effects are not likely to occur. 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 dioctanoate is > 2000mg/kg, hence the substance is not to be classified according to regulation (EC) 1272/2008 for acute oral toxicity as well as for specific target organ toxicity, single exposure (STOT SE).

 

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.

 

Octanoate

Acute oral toxicity

According to the HERA document on fatty acid salts (2002) “the available data for fatty acids provide a clear picture of low acute toxicity for this class of chemicals. All oral LD50values were greater than 2,000 mg/kg, with little mortality being observed even at the highest doses tested in the studies (IUCLID, 2000c, 2000e, 2000f, 2000g; Clayton & Clayton, 1982; CIR, 1987)” (HERA, 2002).

Based on in vivo data it was reported that “in an OECD TG 401 study, a group of five rats/sex was administered octanoic acid at a dose of 2000 mg/kg bw. There were no deaths, clinical signs, or findings at gross necropsy. The LD50was > 2000 mg/kg bw”(OECD SIDS, 2014).

“Smyth et al. (1962) studied the acute oral toxicity of undiluted caprylic- or capric acid (mixed isomers tested) in groups of five non-fasted male Carworth–Wistar rats. Based upon mortalities during the 14-day observation period, the authors reported median lethal dose (LD50) values of 1,300 mg/kg bw for caprylic acid and 3,300 mg/kg bw for capric acid (no further details available). Jenner et al. (1964) administered, by gavage, increasing doses of caprylic acid to groups of five male and five female fasted Osborn–Mendel rats (dose range 8,190–12,370 mg/kg bw). The treated rats showed depression and diarrhoea during the 2-week observation period. The rats died between 4 h and 9 days after application. The authors calculated a LD50of 10,080 mg/kg bw for male and female rats (no further details given)” (EFSA ANS Panel, 2017).

The EFSA ANS Panel concluded that caprylic acid has a low acute oral toxicity.

Justification for classification or non-classification

The calculated oral LD50 for zinc dioctanoate is > 2000mg/kg, hence the substance is not to be classified according to regulation (EC) 1272/2008 for acute oral toxicity as well as for specific target organ toxicity, single exposure (STOT SE).

Zinc dioctanoate is not classified for acute inhalative toxicity because of lacking data.