Reaction product of soluble nickel salt, cobalt salt, manganese salt with alkalines

Endpoint summary

Additional information

The main components of the substance “Reaction product of soluble nickel salt, cobalt salt, manganese salt with alkalines” are cobalt hydroxide, nickel hydroxide and manganese hydroxide.

Cobalt and nickel are considered as the main drivers for human health effects. This transported isolated intermediate is an inorganic solid UVCB-substance . The major and the most hazardous constituents of this intermediate are cobalt hydroxide and nickel hydroxide, which vary within different products 1-35% and 30 -90%, respectively. Because of fine particles

(IUCLID-section 4.5: particle size)

, dust emissions might cause exposure through inhalation for workers, and therefore controlled by existing RMMs taken place in production processes and intermediate use under strictly controlled conditions (see section 11 of IUCLID). Due to intermediate use under strictly controlled conditions further hazard assessment is deemed unnecessary.

Studies presented exhibit genetic toxicity:

Cobalt hydroxide oxide (Lloyd, 2010): negative

Nickel hydroxide (BSL, 2008): positive

Nickel hydroxide (Fletcher, 1994): positive, dose-dependent

Nickel hydroxide (Rossetto, 1994): positive

Hypothesis and justification for read-across: Cobalt hydroxide oxide and nickel hydroxide are the main components of the target UVCB-substance, and considered the major drivers for adverse effects based on their properties and relative quantity in the substance. For read-across purpose, data from the constituents (cobalt hydroxide oxide and nickel hydroxide) of the target UVCB-substance is used. According to section 1.5, annex XI of regulation (EC) 1907/2006, such studies do not need to be conducted, since adequate data from structurally analogous substances are available. Therefore read-across from these compounds is justified.

Self-classification of this intermediate was determined based on the CLP rules for mixtures. Classification was done taking into account the composition and C&L entries of the classified constituents of this intermediate (see remarks in sections 2.1 and 2.2).

Short description of key information:
The main components of the substance “Reaction product of soluble nickel salt, cobalt salt, manganese salt with alkalines” are cobalt dihydroxide, nickel dihydroxide and manganese dihydroxide. Cobalt and nickel are considered as the main drivers for human health effects. This transported isolated intermediate is an inorganic solid UVCB-substance. The major and the most hazardous constituents of this intermediate are cobalt dihydroxide and nickel dihydroxide, which vary within different products 1-35% and 30-90%, respectively. Because of fine particles (IUCLID-section 4.5: particle size), dust emissions might cause exposure through inhalation for workers, and therefore controlled by existing RMMs taken place in production processes and intermediate use under strictly controlled conditions (see section 11 of IUCLID). Due to intermediate use under strictly controlled conditions further hazard assessment is deemed unnecessary.

Self-classification of this intermediate was determined based on the CLP rules for mixtures. Classification was done taking into account the composition and C&L entries of the classified constituents of this intermediate (see remarks in section 2.2).

Endpoint Conclusion:

Justification for classification or non-classification

Self-classification of this intermediate was determined based on the CLP rules for mixtures. Classification was done taking into account the composition and C&L entries of the classified constituents of this intermediate (see remarks in sections 2.1 and 2.2).

The UVCB-substance "Reaction product of soluble nickel salt, cobalt salt, manganese salt with alkalines" will be classified:

CLP:

Muta. 2; H341

DSD, Directive 1999/45/EC:

Muta cat. 3; R68