Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no hazard identified

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

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:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Conclusion on classification

The substance is an inorganic substance containing the metals barium, strontium, europium, magnesium, manganese and aluminium. Consequently any classification based on the metals strategy presented in the ECHA Guidance on the Application of the CLP criteria should be investigated. In case of this particular substance, any classification based on the barium (Ba), strontium (Sr), europium (Eu), magnesium (Mg), manganese (Mn) and/or aluminium (Al) ions need to be investigated, considering the rate and extent of transformation/dissolution of these elements from the substance.

The substance is a complex metal oxide and it is not expected that the substance will release considerable amounts of soluble (ionic) species under environmental conditions, based on the following considerations:

 

- The type of substance and its manufacturing process. See IUCLID section 1.

- The substance is insoluble in water. See IUCLID section 4.8.

- Experiences made during the development of an ICP-MS method for the quantitative analysis of the substance in aqueous test media.

Extreme harsh conditions were required to dissolve/decompose the substance into its metal ions. See IUCLID section 8.

 

Therefore, none of the metals oxides contained in the substance are expected to be dissolved from the substance under environmentally relevant conditions, to form considerable amounts of ionic species.

As supportive information, the aquatic toxicity of the metals contained in the substance has been investigated:

- Strontium has a low toxicity to freshwater organisms. Most available tests are performed with strontium chloride (which is not classified as hazardous for the environment) with L(E)C50s ranging from 75 to 910 mg Sr/L. There are no chronic no-observed-effect concentrations (NOECs) for aquatic organisms available (Reference: WHO report on STRONTIUM AND STRONTIUM COMPOUNDS (Concise International Chemical Assessment Document 77); http://www.inchem.org/documents/cicads/cicads/cicad77.pdf). Based on the lowest available acute L(E)C50 of strontium (75 mg Sr/L) and the molecular weights of strontium (87.62 g/mole) and of the substance (approx. 700 g/mole), the acute ERVcompound is >100 mg/L. Based on the low acute toxicity of strontium and the amount of strontium contained in the substance, it is considered justified to conclude that the chronic ERVcompound is >1 mg/L. Therefore it is concluded that strontium is not relevant.

- In the generic entry of barium salts in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation), no environmental classification is included.

- As the content of europium and manganese in the substance is low, investigating classification of the substance based on these elements is not considered needed.

- The aluminium ion is not hazardous for the environment. Many aluminium compounds that dissociate in water into their ions are included in Annex VI of the CLP Regulation, without an environmental classification. This is because the aluminium ion precipitates at an environmental pH range; it is rapidly removed from the water column.

- The magnesium ion is not hazardous for the environment. Acute toxicity values for the magnesium ion are >100 mg/L.

Conclusions

Based on the available information, it is not considered justified to classify the substance for environmental effects and performing the study Transformation/Dissolution of Metals and Metal compounds in aqueous media according to Annex 10 of UN GHS is considered scientifically unjustified. None of the metals contained in the substance are expected to dissolute significantly from the substance, under environmental conditions, nor are considered relevant for the classification of the substance.