Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving

Workers - Hazard for the eyes

Additional information - workers

Nickel slag is a complex metal containing substance. It mainly contain iron silicate and silicates of aluminum and calcium. Traces of metals exist in metal, mineral form or included in silicate phases.

The toxicity and classification is therefore related to:

-        Amount of metals present (%)

-        Speciation of metals

-        Degree to which the metal constituents react with water / biological fluids and release soluble, potentially bio available ionic and other metal bearing species.

-        Rules for classification of mixtures as defined in the CLP regulation (2009)

Classification derived using read accross approach based on high quality test data on skin irritation, eye irritation, acute toxicity via oral and dermal route, bacterial gene mutation test and bacterial survival test for the analogue substance slag, copper smelting

Results demonstrate that: 

-        Copper slag is not skin irritant. The absence of irritation effects furthermore excludes the possibility for corrosion, defined as serious damage of tissues throughout the skin thickness.

-        Copper slag is not harmful and not toxic via oral and dermal route.

-        Copper slag is not mutagenic and does not affect bacteria survival.

Based on this outcome for the source substance, the absence of skin irrittaion, acute toxicity via oral and dermal route and mutagenicity is predicted for the target subtance nickel slag.

Classification of nickel slag was furthermore derived based on the rules for mixtures (CLP regulation).

The assessed samples are representative for typical nickel slags and fall within the concentration ranges outlined under IUCLID section 1.2.

Data from in vitro bio-accessibility tests in biological fluids (gastric and sweat) are further used to refine /confirm the classification.

Conclusively based on consideration of toxicity data, chemical composition, speciation and reduced bio-accessibility, nickel slags do not need classification for human health hazards.

A summary of the human health classification is attached.

Detailed explanation and justification are provided in records for every endpoint

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Nickel slag is a complex metal containing substance. It mainly contain iron silicate and silicates of aluminum and calcium. Traces of metals exist in metal, mineral form or included in silicate phases.

The toxicity and classification is therefore related to:

-        Amount of metals present (%)

-        Speciation of metals

-        Degree to which the metal constituents react with water / biological fluids and release soluble, potentially bio available ionic and other metal bearing species.

-        Rules for classification of mixtures as defined in the CLP regulation (2009)

Classification derived using read accross approach based on high quality test data on skin irritation, eye irritation, acute toxicity via oral and dermal route, bacterial gene mutation test and bacterial survival test for the analogue substance slag, copper smelting

Results demonstrate that: 

-        Copper slag is not skin irritant. The absence of irritation effects furthermore excludes the possibility for corrosion, defined as serious damage of tissues throughout the skin thickness.

-        Copper slag is not harmful and not toxic via oral and dermal route.

-        Copper slag is not mutagenic and does not affect bacteria survival.

Based on this outcome for the source substance, the absence of skin irrittaion, acute toxicity via oral and dermal route and mutagenicity is predicted for the target subtance nickel slag.

Classification of nickel slag was furthermore derived based on the rules for mixtures (CLP regulation).

The assessed samples are representative for typical nickel slags and fall within the concentration ranges outlined under IUCLID section 1.2.

Data from in vitro bio-accessibility tests in biological fluids (gastric and sweat) are further used to refine /confirm the classification.

Conclusively based on consideration of toxicity data, chemical composition, speciation and reduced bio-accessibility, nickel slags do not need classification for human health hazards.

A summary of the human health classification is attached.

Detailed explanation and justification are provided in records for every endpoint