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Administrative data

Description of key information

No acute toxicity studies with fatty acids, C9-13-neo-, copper salts are available, thus the acute toxicity will be addressed with existing data on the individual moieties copper and neodecanoic acid (being representative for fatty acids, C9-13-neo-).

Signs of acute oral and dermal toxicity are not expected for the moiety neodecanoic acid, since the LD50 is greater than 2000 mg/kg bw. The studies for moiety copper were assessed in a weight of evidence approach. The oral LD50 value is 197 mg Cu/kg bw. Further, copper sulphate is legally classified (Regulation 1272/2008; Index No. 029 -004 -00 -0) for acute oral toxicity category 4. The dermal LD50 value for copper is >2000 mg Cu/kg bw.

The calculated oral LD50 for fatty acids, C9-13-neo-, copper salts is 300 < LD50 <= 2000, thus the substance is classified according to regulation (EC) 1272/2008 for acute oral toxicity category 4 (H302: Harmful if swallowed).

The calculated dermal LD50 for fatty acids, C9-13-neo-, copper salts is >2000 mg/kg bw, thus the substance is not classified for acute dermal toxicity.

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

Copper

Acute oral toxicity

Three relevant and reliable GLP studies (Lheritier 1994, Sanders 2001a, Sanders 2002) tested different copper substances in regard to acute oral toxicity. All studies were used in a weight of evidence approach. Sanders (2002) assessed acute oral toxicity of copper oxide in rats conducting an OECD No.423 study. The test substance induced showed no systemic toxicity and a LD50 >2500 mg/kg bw was determined. In contrast, Lheritier (1994) and Sanders (2001a) showed comparable results in regard to acute oral toxicity for coppersulphateand coated copper flakes, respectively. In an OECD No. 401 study, Sanders (2001) estimated a LD50 in rats to be in the range of 300-500 mg/kg bw. Lheritier (1994) determined a LD50, for copper sulphate, in rats of about 481-482 mg/kg bw in a OECD No. 401 study. 

Copper sulphate is characterized best and has a LD50 of 481 mg/kg bw. Based on the assumption that copper is the moiety of concern and responsible for adverse effects observed, a LD50 for copper of about 197.2 mg/kg bw could be calculated based on the molecular weight.

Moreover, copper sulphate is legally binding classified (Regulation (EC) No. 1272/2008; Index No. 029-004-00-0) for acute oral toxicity category 4 (H302: Harmful if swallowed). 

 

Acute dermal toxicity

Three relevant and reliable GLP studies (Lheritier 1993, Sanders 2001b, Sanders 2002) tested different copper substances in regard to acute dermal toxicity. All studies were used in a weight of evidence approach. All studies were performed in rats according to OECD test guideline No. 402. None of the copper substances tested showed acute dermal toxicity and, thus LD50 was determined to be greater than 2000 mg/kg bw. All studies were used in a weight of evidence approach. The LD50 for copper salt is set accordingly to be greater than 2000 mg/kg bw.

 

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. 

Fatty acids, C9-13-neo-, copper salts

No acute toxicity studies with fatty acids, C9-13-neo-, copper salts are available, thus the acute toxicity will be addressed with existing data on the individual moieties copper and neodecanoic acid (being representative for fatty acids, C9-13-neo-).

The oral LD50 for fatty acids, C9-13-neo-, copper salts is based on the LD50 values of the assessment entities copper and neodecanoic acid. Based on the oral LD50 value for copper of 197 mg Cu/kg bw and the oral LD50 values of neodecanoic acid of >2000 mg/kg bw, the calculated LD50 for fatty acids, C9-13-neo-, copper salts is 300 < LD50 <= 2000, thus the substance is classified according to regulation (EC) 1272/2008 for acute oral toxicity category 4 (H302: Harmful if swallowed).

The dermal LD50 for fatty acids, C9-13-neo-, copper salts is based on the LD50 values of the assessment entities copper and neodecanoic acid. Based on the dermal LD50 value for copper of >2000 mg Cu/kg bw and the dermal LD50 value of neodecanoic acid of >2000 mg/kg bw, the calculated dermal LD50 for fatty acids, C9-13-neo-, copper salts is >2000 mg/kg bw, thus the substance is not classified for acute dermal toxicity.

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

The calculated oral LD50 for fatty acids, C9-13-neo-, copper salts is 300 < LD50 <= 2000, thus the substance is classified according to regulation (EC) 1272/2008 for acute oral toxicity category 4 (H302: Harmful if swallowed).

The calculated dermal LD50 fatty acids, C9-13-neo-, copper salts is >2000 mg/kg bw, thus the substance is not classified for acute oral toxicity.

No adverse effects were observed upon necropsy in the acute oral toxicity studies with the assessment entity copper or neodecanoic acid (being representative for fatty acids, C9-13-neo-) that would justify a classification for specific target organ toxicity-single exposure.