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

Endpoint summary

Description of key information

No acute toxicity studies with fatty acids, C9-13-neo-, barium salts are available, thus, the acute toxicity will be addressed with existing data on the assessment entities barium and neodecanoate. As detailed in the RAAF report, neodecanoic is considered as representative of fatty acids, C9-13 -neo-. No adverse effects were observed in acute oral toxicity studies with neodecanoate. Due to the legal classification of all barium salts (Index Nr. 056-002-00-7) and taking into account the acute toxicity data for barium salts, fatty acids, C9-13-neo-, barium salts is classified with acute toxicity via the oral route category 4 (H302).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Barium

Acute oral toxicity

There are three reliable studies for acute oral toxicity testing (Müller, 1983, Borzelleca, 1988 and Tardiff, 1980). All studies were used in a weight of evidence approach. The study performed by Müller, 1983 results in a LD50 of 645 mg BaCl2/kg bw (male/female), the study performed by Borzelleca in 1988 leads to a LD50 >100 and <300 mg/kg bw., whereas the study conducted by Tardiff 1980 results in a LD50 of 300 mg/kg bw.

 

Acute dermal toxicity

According to the SIAR 27 prepared for barium dichloride, an acute dermal toxicity study on barium dichloride was conducted according to OECD 402, in compliance with GLP. In this study, the dermal LD50 was greater than 2000 mg BaCl2/kg bw in rats. Nevertheless, primary data could not be made available by the registrant.

 

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-, barium salts

Since no repeated dose toxicity study is available specifically for fatty acids, C9-13-neo-, barium salts, information on the individual moieties barium and neodecanoate will be used for the hazard assessment of fatty acids, C9-13-neo-, barium salts. As detailed in the RAAF report, neodecanoic is considered as representative of fatty acids, C9-13 -neo-. No adverse effects were observed in acute oral toxicity studies with neodecanoate. However, due to adverse effects observed in acute oral toxicity studies with barium as well as considering the read-across principles for fatty acids, C9-13-neo-, barium salts, one may safely assume that this substance will show acute oral toxicity. Signs of acute dermal toxicity are not expected for fatty acids, C9-13-neo-, barium salts, since the two moieties barium and neodecanoic acid have not shown signs of acute dermal toxicity in experimental testing (LD50 > 2000mg/kg). Under the assumption that the moieties of fatty acids, C9-13-neo-, barium salts show their toxicological profile individually upon dissolution, the acute dermal toxicity of fatty acids, C9-13-neo-, barium salts 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 fatty acids, C9-13-neo-, barium salts, 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 assessment entities, please refer to the relevant sections in the IUCLID and CSR.

Justification for classification or non-classification

Based on adverse effects observed in acute oral toxicity studies with barium and taking into account the legal classification of barium salts for acute toxicity via the oral route, fatty acids, C9-13-neo-, barium salts, is classified as acute toxic via the oral route (Category 4, H302). The calculated dermal LD50 for fatty acids, C9-13-neo-, barium salts is > 2000mg/kg, hence the substance is not to be classified according to regulation (EC) 1272/2008 for acute dermal toxicity. There were no effects observed in the acute oral and dermal toxicity studies that would justify a classification for specific target organ toxicity, single exposure (STOT SE, oral and dermal). The effects observed in the acute oral toxicity studies with barium already lead to the classification for acute oral toxicity.