Fatty acids, C14-18 and C16-18-unsatd., barium salts

Endpoint summary

Description of key information

Fatty acids, C14-18 and C16-18, unsatd. barium salts is not expected to show acute toxic effects via dermal route. 
The calculated oral ATE for  fatty acids, C14-18 and C16-18, unsatd. barium salts is 424, taking into account the ATE values of the individual constituents given in the table above and the maximum barium content of 22% and the maximum  fatty acids, C14-18 and C16-18, unsatd. content of 78% in  fatty acids, C14-18 and C16-18, unsatd. barium salts.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

424 mg/kg bw

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

Introduction

A comprehensive data gap analysis was conducted for the entire substance portfolio of the Metal carboxylates REACH Consortium (MCRC), covering 10 metal carboxylates in total. This literature screening effort included:

 

•            all available proprietary studies from the Metal carboxylates REACH Consortium (MCRC)

•            detailed literature searches in online databases

•            screening of human health review articles

•            rigorous quality and reliability screening according to Klimisch criteria, where those criteria apply

 

During the literature search and data gap analysis it became obvious that the overall database on substance-specific human health hazard data for the metal carboxylates is too scant to cover all REACH endpoints. Therefore, the remaining data gaps had to be covered by either experimental testing or read-across from similar substances.

 

Selected endpoints for the human health hazard assessment are addressed by read-across, using a combination of data on the organic acid counterion and the metal (or one of its readily soluble salts). This way forward is acceptable, since metal carboxylates dissociate to the organic anion and the metal cation upon dissolution in aqueous media. No indications of complexation or masking of the metal ion through the organic acid were apparent during the water solubility tests (please refer to the water solubility data in section of the IUCLID and chapter of the CSR). Once the individual constituents of the metal carboxylate become bioavailable (i.e. in the acidic environment in the gastric passage or after phagocytosis by pulmonary macrophages), the “overall” toxicity of the dissociated metal carboxylate can be described by the toxicity of the “individual” constituents. Since synergistic effects are not expected for this group of metal carboxylates, the human health hazard assessment consists of an individual assessment of the metal cation and the organic anion.

 

The hazard information of the individual constituents was obtained from existing REACH registration dossiers via a license-to-use obtained by the lead registrant. These registration dossiers were submitted to ECHA in 2010 as full registration dossiers, and are thus considered to contain relevant and reliable information for all human health endpoints. All lead-registrant dossiers were checked for completeness and accepted by ECHA, i.e. a registration number was assigned.

 

Fatty acids, C14-18 and C16-18, unsatd. barium salts is the barium metal salt of Fatty acids, C14-18 and C16-18, unsatd, which readily dissociates to the corresponding metal barium cation and Fatty acids, C14-18 and C16-18, unsatd, anions. The barium cation and the Fatty acids, C14-18 and C16-18, unsatd anion are considered to represent the overall toxicity of Fatty acids, C14-18 and C16-18, unsatd. barium salts in a manner proportionate to the free acid and the metal (represented by one of its readily soluble salts). Based on the above information, unrestricted read-across is considered feasible and justified.

 

Although the term „constituent“ within the REACH context is defined as substance (also being part of a mixture), the term constituent within this hazard assessment is meant to describe either part of the metal carboxylate salt, i.e. anion or cation.

 

Acute toxicity

No acute toxicity studies with fatty acids, C14-18 and C16-18, unsatd. barium salts are available, thus the acute toxicity will be addressed with existing data on the dissociation products as detailed in the table below. Further details on the acute toxicity of the individual constituents within the framework of regulation (EC) 1907/2006 are given below.

 

Table: Summary of acute toxicity data of fatty acids, C14-18 and C16-18, unsatd. barium salts and the individual constituents.

	BaCl2 (CAS# 10361-37-2)	Fatty acids, C14-18 and C16-18-unsatd. (CAS#67701-06-8)	Fatty acids, C14-18 and C16-18, unsatd. barium salts (CAS# 95465-85-3)
Acute oral toxicity	LD50≥100 till ≤300 mg/kg bw LD50(rat) > 66 and <198 mg/kg bw (calculated as Ba2and) Acute Tox 3 (H301)	not acutely toxic to humans	ATE= 424 (calculated)   Acute Tox 4 (H302)
Acute inhalation toxicity	LC50>1 mg/L Acute Tox 4 (H332)		waived
Acute dermal toxicity	LD50(rat)> 2,000 mg/kg bw (supporting data)		LD50>2000 mg/kg bw (calculated)

The acute dermal toxicity for fatty acids, C14-18 and C16-18, unsatd. barium salts is believed to be > 2000mg/kg bw, since both constituents have shown no sign of acute dermal toxicity. Hence the substance is not to be classified according to regulation (EC) 1272/2008 for acute dermal toxicity.

 

Under the assumption that the constituents of fatty acids, C14-18 and C16-18, unsatd. barium salts show their toxicological profile individually upon dissolution, the acute oral toxicity estimate (ATEoral) of fatty acids, C14-18 and C16-18, unsatd. barium salts can be calculated using the equation given in regulation (EC) 1272/2008, Annex I, Section 3.1.3.6.1. The calculated oral ATE for fatty acids, C14-18 and C16-18, unsatd. barium salts is 424, taking into account the ATE values of the individual constituents given in the table above and the maximum barium content of 22% and the corresponding fatty acids, C14-18 and C16-18-unsatd. content of 78% in fatty acids, C14-18 and C16-18, unsatd. barium salts, hence fatty acids, C14-18 and C16-18, unsatd. barium salts will be classified as acutely toxic category 4 via oral route (H302).

 

Further testing is not required. For further information on the toxicity of the individual constituents, please refer to the relevant sections in the IUCLID and CSR.

 

Justification for selection of acute toxicity – oral endpoint
Read-across information. Calculation of the acute oral toxicity estimate for fatty acids, C14-18 and C16-18, unsatd. barium salts

Justification for selection of acute toxicity – inhalation endpoint
Endpoint waived, since the substance is used and placed on the market in a non-inhalable form.

Justification for selection of acute toxicity – dermal endpoint
Read-across information.

Justification for classification or non-classification

The acute dermal toxicity for fatty acids, C14-18 and C16-18, unsatd. barium salts is believed to be > 2000 mg/kg bw, since both constituents have shown no sign of acute dermal toxicity. Hence the substance is not to be classified according to regulation (EC) 1272/2008 and directive 67/548/EEC

for acute dermal toxicity.

Furthermore, no classification for specific target organ toxicity, single exposure (STOT SE) is required based on the acute dermal toxicity data.

 

The acute oral toxicity estimate (ATEoral) of fatty acids, C14 -18 and C16-18, unsatd. barium salts is 424, taking into account the ATE values of the individual constituents given in the table above and the maximum barium content of 22% and the corresponding fatty acids, C14-18 and C16-18-unsatd. content of 78% in fatty acids, C14-18 and C16-18, unsatd. barium salts, hence fatty acids, C14 -18 and C16-18, unsatd. barium salts will be classified as acutely toxic category 4 via oral route (H302, R20).

Calculated oral ATE fits to harmonized legally binding classification to be applied. The substance is a barium salt, and thus has to be classified in accordance with tables 3.1 and 3.2 REGULATION (EC) No 1272/2008, Index No: 056-002-7 (barium salts in general) for acute oral and inhalative toxicity (Cat 4/H302, H332; Xn R20/22).

 

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.