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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 dust having 100% of the particle size distribution belonged to the inhalable fraction (<100 micrometers) (IUCLID-section 4.5: particle size). 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, 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).

Key value for chemical safety assessment

Additional 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.

Studies presented for irritation properties:

Skin irritation

Cobalt dihydroxide: no data available

Nickel dihydroxide: irritating (EPSL, 2008)

Eye irritation

Cobalt dihydroxide: not irritating (Vinegar, 1977)

Nickel dihydroxide: mildly irritating (EPSL, 2008)

Hypothesis and justification for read-across: Cobalt dihydroxide and nickel dihydroxide 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 dihydroxide and nickel dihydroxide) 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).


Effect level: empty Endpoint conclusion: Adverse effect observed

Effect level: empty Endpoint conclusion: Adverse effect observed

Effect level: empty Endpoint conclusion: Adverse effect observed

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:

Skin irritation

CLP: Skin irrit. 2; H315

DSD, Directive 1999/45/EC: Xi, R36/38

Eye irritation

CLP: Eye irrit. 2; H319

DSD, Directive 1999/45/EC: Xi, R36/38