Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
174 µg/L

Marine water

Hazard assessment conclusion:
no data: aquatic toxicity unlikely

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
94.3 mg/L
Assessment factor:
10

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
908 mg/kg sediment dw
Assessment factor:
1
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
314.9 mg/kg soil dw
Assessment factor:
2

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Read across approach:

In the assessment of the environmental fate and behaviour of barium substances, a read-across approach is applied based on all information available for inorganic barium compounds. This is based on the common assumption that after emission of metal compounds into the environment, the moiety of toxicological concern is the potentially bioavailable metal ion (i.e., Ba2+). The dissolution of barium substances in the environment and corresponding dissolved Ba levels are controlled by the solubility of barite (BaSO4) and witherite (BaCO3), two naturally occurring barium minerals (Ball and Nordstrom 1991; Menzie et al, 2008), and the concentration of dissolved Ba cations in freshwater is rather low. However, in the dissolved state, the divalent barium cation, is the predominant form in soil, sediments and water. The solubility of barium compounds increases as solution pH decreases (US EPA, 1985a). Nevertheless, the speciation of barium in the environment is considered to be rather simple (USEPA 2005):

-         Barium cations are not readily oxidized or reduced

-         Barium cations do not bind strongly to most inorganic ligands or organic matter

 

Barium  in soils  is not  expected  to  be  very mobile  because of the formation  of water-insoluble salts (sulphate and carbonate) and its inability to form soluble complexes with humic and fulvic materials.  Under acid conditions, however, some of the  water-insoluble  barium compounds  may become soluble and move into ground water (US EPA, 1984).

 

In sum, transport, fate, and toxicity of barium in the environment are largely controlled by the solubility of barium minerals. The barium cation is the moiety of toxicological concern, and thus the hazard assessment is based on Ba2+.

 

US EPA (1985a) Health advisory — barium. Washington, DC, US Environmental Protection Agency, Office of Drinking Water.

 

US EPA (1984) Health effects assessment for barium,Cincinnati, Ohio, US Environmental Protection Agency, Office of Health and Environmental

Assessment, Environmental Criteria and Assessment Office (Prepared for the Office of Emergency and Remedial Responsible, Washington, DC) (EPA 540/1-86-021).

PNEC marine water:

A relevant PNEC for the marine environment cannot be determined, for the following reasons:

(i) Barium levels in sea water range from 2 to 63 μg/L with a mean concentration of about 13 μg/L (Bowen 1979).

(ii) Applying ECHA-guidance, the derived marine PNEC of 11.5 μg/L for barium (PNEC freshwater = 0.115 mg Ba/L and an AF of 100) would thus be within the range of typical barium seawater levels.

(iii) Seawater contains about 2700 mg/L sulfate (Hitchcock, 1975 cited in WHO, 2004).

(iv) Barium transported into marine systems combines with sulfate ions present in salt water to form barium sulfate.

(v) Barium in marine environments is in a steady state; the amount entering is balanced by the amount falling to the bottom as barium sulfate (barite) particles to form a permanent part of the marine sediment (Wolgemuth & Brocker, 1970). Thus, dissolved barium concentrations are controlled by the solubility of barium sulfate. The solubility product (Ksp) of barium sulfate is 1.08E-10(CRC Handbook, 2008), resulting in maximum dissolved Ba levels of approximately 1.4 mg/L.

(vi) In sum, due to high sulfate levels in the marine environment and a low solubility of barium sulfate, dissolved barium levels will remain constant in marine waters, regardless of the amount of barium introduced to the system.

 

References:

Bowen HMJ (1979) Environmental Chemistry of the Elements. Academic Press, London, 333 pp.

Lide, D.R. (2008) CRC Handbook of chemistry and physics. 88thedition.

Hitchcock DR (1975) Biogenic contributions to atmospheric sulphate levels. In: Proceedings of the 2nd National Conference on Complete Water Re-use. Chicago, IL, American Institute of Chemical Engineers.

WHO (1990) Barium. Environmental Health Criteria 107. International Programme on Chemical Safety.

WHO (2004) Sulfate in Drinking-water. Background document for development of WHO Guidelines for Drinking-water Quality. WHO/SDE/WSH/03.04/114.

Wolgemuth K & Broecker WS (1970) Barium in sea water. Earth planet. Sci. Lett., 8: 372-378.

 

PNEC sediment:

The PNECsedimentcan be derived from the PNECaquaticusing the equilibrium partitioning method (EPM).

 

A distribution/partition coefficient (KD) between the water and sediment compartment for barium has been determined (see chapter 4). This resulted in a typical KD, susp-waterof 5,217 L/kg (logKD: 3.72). In a first step the units have to be converted from L/kg to m3/m3using the formula below.

 

KD, susp-water(m3/m3) = 0.9 + [0.1 x (KD, susp-water(L/kg) x 2,500) / 1,000]

 

This results in a KD, sedimentof 1,305 m3/m3. This value can be entered in the equation below to calculate the PNECsediment:

 

PNECsediment= (KD, susp-water/ RHOsusp) x PNECaquaticx 1,000

 

with the PNECaquaticexpressed as mg/L, RHOsusprepresenting the bulk density of wet suspended matter (freshly deposited sediment) (1,150 kg/m3), and a KD, susp-waterof 1,305 m3/m3, a PNECsedimentthat is expressed as mg/kg wet weight can be derived. This value can be converted to a dry weight-based PNEC, using a conversion factor of 4.6 (CONVsusp = RHOsusp/Fsolid-susp * RHOsolid) kg wet weight/ kg dry weight.

This results in aPNECsediment of 600 mg Ba/kg dry sediment corresponding to 908 mg BaCl2/kg dry sediment.

 

PNEC soil:

 

Derivation of a PNEC for the terrestrial compartment according to the assessment factor method resulted in a PNEC well below typical background levels for the majority of EU-countries. Therefore a more relevant PNEC was derived based on reported baseline levels of Ba in EU top soil samples. The outlier cut-off level for Ba baseline levels (i.e., 415.7 µg/L) was used as a starting point. A factor of two was applied to the cut-off level and a PNEC soil of 207.7 mg Ba/kg dry wt is derived and considered as a reliable, provisional PNEC for the terrestrial compartment. For more information please refer to the CSR.

 

 

PNEC for sewage treatment plant:

In general, an AF of 10 is to be applied to the NOEC/EC10of a sludge respiration test, reflecting the lower sensitivity of this endpoint as compared to nitrification, as well as the short duration of the test. The corresponding AF is 100 when based on the EC50. The PNECmicro-organismis set equal to a NOEC (AF = 1) for a test performed with specific bacterial populations such as nitrifying bacteria,P. putida, ciliated protozoa, the Shk1 Assay. An EC50from this test is divided by an AF of 10 to derive thePNECmicro-organism. No AF is needed to derive a PNECmicro-organismbased on good quality field data.

The lowest reliable observed NOEC/EC10-value for respiration (inhibition of respiration after a 3h incubation period) using activated sludge was ≥943.1 mg BaCl2/L. Based on the guidance given in the RIP3.2 (ECHA, 2008) and the TGD (2003), an assessment factor of 10 should be used on this value, as respiration is the endpoint.

Application of an assessment factor of 10 on this value of 943.1 mg BaCl2/L, results in a PNECmicro-organismof 94.3 mg BaCl2/L.

 

PNECoral(secondary poisoning):

No avian toxicity data are available

-         Data from an NTP (1994) study resulted in NOAELs for rats ranging between 61 and 115 mg Ba/kg/d, depending on the exposure period (13 wk, 2 yr). Evaluated endpoints were renal and cardiovascular effects.

-         Data from an NTP (1994) study resulted in NOAELs for mice ranging between 61 and 115 mg Ba/kg/d, depending on the exposure period (13 wk, 2 yr). Evaluated endpoints were renal and cardiovascular effects.

-         A 13 wk reproduction study with rat and mice (Dietz et al, 1992), resulted in a NOAEL of 200 mg Ba/kg/d for both test species.

According to ECHA-Guidance (ECHA, 2008: Chapter R.10 – Dose (concentration)-response regarding environment) a NOECmammalcan be derived from a NOAELmammal,using the following formula:

NOECmammal_food_chronic= NOAELmammal_food_chronic x CONVmammal

with CONVmammala species-specific conversion factor. The conversion factor for rats is 10-20, depending on the age of the test organisms.

As endpoints like mortality, growth and reproduction are strongly preferred for the derivation PNECoral, the value of 200 mg/kg bw/d (NOAELreproductionfor rats and mice) was used as reference value for the derivation of a PNECoral.

The age of the test organisms was not specified; therefore a conversion factor of 10 kg bw.d/kg food

NOECmammal_food_chronic= 200 mg /kg bw/d * 10 kg bw.d/kgfood= 2000 mg Ba/kgfood

The PNECoralthat can be derived from this NOEC-value by applying an adequate assessment factor on the NOEC. An assessment factor of 90 is required when a 90d-NOEC for mammals is used as reference value. An estimated PNECoralfor barium would be 2000 mg Ba/kg food / 90 = 22.2 mg/kg food

It should be noted that, according to the ECHA technical guidance on environmental hazard assessment, ‘if a substance has a bioaccumulation potential and a low degradability, it is necessary to consider whether the substance also has the potential to cause toxic effects if accumulated in higher organisms.’ It further states that the assessment of secondary poisoning takes place as a tiered process, where the first step is to evaluate the bioaccumulative potential of a substance, following the criterion that if BCF ≥ 100 (together with considerations regarding biodegradability). When this criterion is met, the subsequent step to calculate a PNECoral,predator is needed.

As barium does not meet this requirement, no PNECoral,predatoris required for this substance.

 

Conclusion on classification

Short-term toxicity EC/LC50 values of barium available for 3 trophic levels are situated between > 1.15 mg Ba/L and 14.5 mg Ba/L, corresponding to > 1.74 mg/L and 22 mg/L barium dichloride. In accordance with Regulation (EC) No 1272/2008, Table 4.1.0 (a), classification for acute aquatic hazard is not required for barium dichloride as all EC50/LC50 values are above the classification criteria of 1 mg/L.

Long-term toxicity data are available for three trophic levels and range from ≥ 1.15 mg Ba/L to 2.9 mg Ba/L, corresponding to ≥ 1.74 mg/L and 4.4 mg/L barium dichloride. In accordance with Regulation (EC) No 1272/2008, Table 4.1.0 (b) (i), classification for chronic aquatic hazard is not required for barium dichloride as all chronic EC10/NOEC values are above the classification criteria of 1 mg/L.