Barium neodecanoate

Endpoint summary

Description of key information

Acute oral toxicity: LD50 ≥ 100 till ≤ 300 mg/kg bw
Acute dermal toxicity: derogation statement included; according to SIAR 2008 an LD50 > 2000 mg/kg was stated in the NIAR report 2008
Acute inhalation toxicity: LC50 > 1 mg/L.

Justification for classification or non-classification

Acute oral toxicity

There are two reliable studies for acute oral toxicity testing (Borzelleca_ 1988 and Tardiff 1980). Both studies were used for weight of evidence. The study performed by Borzelleca in 1988 leads to an LD50 >100 and <300 mg/kg bw whereas the study conducted by Tardiff 1980 results in an LD50 of 300 mg/kg bw. Taken both studies into consideration for classification an LD50 ≤ 300 mg BaCl2/kg bw required a classification and labelling as "acute tox 3"; H301 (toxic if swallowed) according to GHS.

Specific target organ toxicant (STOT) – single exposure: oral

The classification criteria according to regulation (EC) 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value, oral for a Category 1 classification of 300 mg/kg bw and at the guidance value, oral for a Category 2 classification of 2000 mg/kg bw in addition to this effects which were responsible for the death of the animals. No classification required.

Acute dermal toxicity

According to the SIAR 27 prepared for barium chloride, an acute dermal toxicity study on barium chloride was conducted according to OECD TG 402, in compliance with GLP. In this study, the dermal LD50 was greater than 2000 mg BaCl2/kg bw in rats. It is note here that the primary data could not be made available by the registrant but using the secondary information no classification according to regulation (EC) 1272/2008 will be necessary for barium chloride.

Acute inhalation toxicity

There is only one study on acute toxicity via inhalation available. This study was performed with a limit concentration of 1.1 mg/L barium chloride dihydrate which relates to a concentration of 0.94 mg/L barium chloride. One out of ten animals died within the observation period. Due to animal welfare reasons, it was decided not to perform a full test with 5 concentrations at higher concentration. Instead, since according to regulation (EC) 1272/2008 the threshold value for LC₅₀is >= 1 mg/L, it can reasonably be stated that the LC₅₀of barium chloride is > 1 mg/L and therefore a classification and labelling of barium chloride as "acute tox. 4"; H332 (harmful via inhalation) according to GHS is required.

Specific target organ toxicant (STOT) – single exposure: inhalation

The classification criteria according to regulation (EC) 1272/2008 as specific target organ toxicant (STOT) – single exposure, inhalation are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value, inhalation for a Category 1 classification of <= 1 mg/L/4h and at the guidance value, inhalation for a Category 2 <= 5 mg/L/4h - > 1 mg/L/4h. No additional classification required.