Registration Dossier

Administrative data

Description of key information

No information on animal testing of Flue dust is available. However, "Flue dust, precious metal refining" (Flue dust 1 - Flue dust 3) with a lead and lead compound content of ≥ 0.5% is considered to be toxic to specific target organ following repeated dose application via oral route and should be labelled with STOT-RE 1; H372 (specific concentration limits of lead compounds; see "justification for classification and non-classification" below), in accordance with Regulation (EC) 1272/2008. 
Further, "Flue dust, precious metal refining" (Flue dust 1 and Flue dust 3) contains >0.1 % nickel sulfate in the composition profile. Nickel sulfate meets the classification criteria for STOT RE 1 via the inhalation route and is therefore included in C&L calculation with MeClas. Flue dust composition profile 2 contains up to 10 % NiO which is also classified as STOT-RE 1.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
repeated dose toxicity: oral
Remarks:
other: prediction from hazard class
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: calculation tool MeClas (www.meclas.eu) is used
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Principles of method if other than guideline:
The C&L for toxic to specific target organ after repeated dose application of Flue dust was determined by using the “Classification criteria for mixtures” of Regulation (EC) 1272/2006 section 3.9.3.4.1 “Classification of mixtures when data are available for all components or only for some components of the mixture”. For detailed information for classification strategy of UVCBs please refer to IUCLID section 13 (attachment “PMC Classification method”).
GLP compliance:
no
Critical effects observed:
not specified

Flue dust, precious metal refining is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of Flue dust, precious metal refining may contribute (as 'relevant' component) to the UVCB toxicity. With knowledge of the composition, mineralogical information and knowledge of corresponding toxicity of the various chemical species, the respective mixture rules in accordance with Regulation (EC) 1272/2008 are used to calculate the C&L of Flue dust, precious metal refining.

MeClas was used to automatically calculate the classification of the UVCB substance. The calculation tool is based on a database containing the human and environmental hazard information for each component relevant for classification. The information on the representative mineralogical composition (distribution pattern for each constituent of the UVCB substance) is incorporated into MeClas as well.

 

From the derived hazard category (output of MeClas) the corresponding human health (HH) toxicity value was deduced.

 

The following data were used as input of MeClas:

 

1. Classification from individual components according to Annex VI of the CLP regulation (Regulation (EC) 1272/2008) and the 2nd ATP to this regulation, unless additional information on self-classification was used.

 

2. Percentage of the components in the UVCB: individual total element concentrations (percentages based on total substance amount) were recalculated into percentage of the classified chemical species (i.e. substance), taking into account the distribution pattern of the respective element in its present various mineral forms if such information was available.

Conclusions:
General note:
According to the self-classification of lead compounds the specific concentration limits (SCL) for STOT RE classification are as follows:
STOT RE 1; H372: C ≥ 0.5%
STOT RE 2; H373: 0.05% ≤ C < 0.5%

Therefore, the following C&L driver is identified for Flue dust, precious metal refining (Flue dust 1 - Flue dust 3) for the oral route:
(i):classification driver lead and lead compound (oral route, systemic effects)

Classification of UVCB substances as being toxic to specific target organs after repeated dose application is based on the presence of a constituent ≥ 1 % classified as STOT-RE 1 and/or on the presence of a constituent ≥ 10 % classified as STOT-RE 2, respectively. Since Flue dust, precious metal refining with the composition profiles 1 - 3 (Flue dust 1 - Flue dust 3) include lead/lead compounds with a content >=0.5%, Flue dust, precious metal refining (Flue dust 1 - Flue dust 3) must be classified as STOT-RE 1 (oral route) in accordance with Regulation (EC) 1272/2008.
Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of Flue dust, precious metal refining, derived on basis of the mixture C&L rules set forth in Regulation (EC) 1272/2008 using mineralogical information from a representative/worst case sample.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Repeated dose toxicity: inhalation - local effects

Link to relevant study records
Reference
Endpoint:
repeated dose toxicity: inhalation
Remarks:
other: prediction from hazard class
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: calculation tool MeClas (www.meclas.eu) is used
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Principles of method if other than guideline:
The C&L for toxic to specific target organ after repeated dose application of Flue dust was determined by using the “Classification criteria for mixtures” of Regulation (EC) 1272/2006 section 3.9.3.4.1 “Classification of mixtures when data are available for all components or only for some components of the mixture”. For detailed information for classification strategy of UVCBs please refer to IUCLID section 13 (attachment “PMC Classification method”).
GLP compliance:
no
Critical effects observed:
not specified

Flue dust, precious metal refining is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of Flue dust, precious metal refining may contribute (as 'relevant' component) to the UVCB toxicity. With knowledge of the composition, mineralogical information and knowledge of corresponding toxicity of the various chemical species, the respective mixture rules in accordance with Regulation (EC) 1272/2008 are used to calculate the C&L of Flue dust, precious metal refining.

MeClas was used to automatically calculate the classification of the UVCB substance. The calculation tool is based on a database containing the human and environmental hazard information for each component relevant for classification. The information on the representative mineralogical composition (distribution pattern for each constituent of the UVCB substance) is incorporated into MeClas as well.

 

From the derived hazard category (output of MeClas) the corresponding human health (HH) toxicity value was deduced.

 

The following data were used as input of MeClas:

 

1. Classification from individual components according to Annex VI of the CLP regulation (Regulation (EC) 1272/2008) and the 2nd ATP to this regulation, unless additional information on self-classification was used.

 

2. Percentage of the components in the UVCB: individual total element concentrations (percentages based on total substance amount) were recalculated into percentage of the classified chemical species (i.e. substance), taking into account the distribution pattern of the respective element in its present various mineral forms if such information was available.

Conclusions:
General note:
According to the self-classification of nickel sulfate the specific concentration limits (SCL) for STOT RE classification (inhalation) are as follows:
STOT RE 1; H372: C ≥ 1%
STOT RE 2; H373: 0.1% ≤ C < 1%

Therefore, the following C&L driver is identified for "Flue dust, precious metal refining" (Flue dust 1 - Flue dust 3) for the inhalation route:
(i):classification driver: nickel sulfate (inhalation route, local effects)
(II) classification driver: nickel oxide (inhalation route, local effects)

Classification of UVCB substances as being toxic to specific target organs after repeated dose application is based on the presence of a constituent ≥ 1 % classified as STOT-RE 1 and/or on the presence of a constituent ≥ 10 % classified as STOT-RE 2, respectively. Since "Flue dust, precious metal refining" with the composition profiles 1 and 3 (Flue dust 1 and Flue dust 3) include nickel sulfate with a content >=1%, Flue dust, precious metal refining (Flue dust 1 and Flue dust 3) must be classified with regard to the described SCL values as STOT-RE 1 (inhalation route) in accordance with Regulation (EC) 1272/2008.

Flue dust 2 may contain 1 - 10% NiO and thus has to be classified for STOT-RE 1 (inhalation route) as well in accordance with Regulation (EC) 1272/2008.
Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of "Flue dust, precious metal refining", derived on basis of the mixture C&L rules set forth in Regulation (EC) 1272/2008 using mineralogical information from a representative/worst case sample.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records
Reference
Endpoint:
repeated dose toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Critical effects observed:
not specified
Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Link to relevant study records
Reference
Endpoint:
repeated dose toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Critical effects observed:
not specified
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Substance specific information for the UVCB substance "Flue dust, precious metal refining" is not available for the endpoint "Repeated Dose Toxicity". In order to meet the requirements for Annex VII till Annex X of Regulation (EC) 1907/2006, read across information from any constituents being relevant needs to be included. Due to the high number of constituents and variability in C&L it was agreed within the consortium to use the classification information from the individual constituents and calculate the resulting classification by using the generic concentration limits of ingredients of the mixture classified as a specific target organ toxicant that trigger classification of the mixture and respective rules of Regulation (EC) 1272/2006 section 3.9.3.4.Classification of mixtures when data are available for all components or only for some components of the mixture” with the MeClas tool.

In total three different "Flue dust, precious metal refining" grades (Flue dust 1 – Flue dust 3) were identified by the consortium that could be grouped according to their calculated C&L resulting from the individual composition. Thus, for "Flue dust, precious metal refining" one C&L entry (STOT RE 1, oral and inhalation rout) for repeated dose toxicity were calculated.

Justification for classification or non-classification

General notes:

According to the self-classification of lead compounds the specific concentration limits (SCL) for STOT RE classification (oral) are as follows:

STOT RE 1; H372: C ≥ 0.5 %

STOT RE 2; H373: 0.05 % ≤ C < 0.5 %

According to the self-classification of nickel sulfate the specific concentration limits (SCL) for STOT RE classification (inhalation) are as follows:

STOT RE 1; H372: C ≥ 1 %

STOT RE 2; H373: 0.1 % ≤ C < 1 %

Therefore, the following C&L driver were identified for Flue dust, precious metal refining:

(i) classification driver: lead and lead compounds (oral route):

(ii):classification driver: nickel sulfate (inhalation route, local effects)

(iii) classification driver: nickel oxide (inhalation route, local effects)

Flue dust – composition profile 1 - 3:

Classification of UVCB substances as being toxic to specific target organs after repeated dose application is based on the presence of a constituent ≥ 1 % classified as STOT-RE 1 and of a constituent ≥ 10 % classified as STOT-RE 2, respectively. However, for lead compounds there are specific concentration limits given for STOT RE classification assigned by the lead industry. According to Regulation (EC) 1272/2008 “specific concentration limits” should take precedence over any other concentration limits for the purpose of classification. Hence, the SCLs for lead compounds are used also for C&L of Flue dust. Since "Flue dust, precious metal refining" (Flue dust 1 - Flue dust 3) contains lead and lead compounds in concentrations relevant for C&L (lead compounds ≥0.5 %), "Flue dust, precious metal refining" meets classification criteria for STOT-RE 1 (oral route) and requires labelling with H372 (causes damage to organs), in accordance with Regulation (EC) 1272/2008.

 

Further, "Flue dust, precious metal refining" with the composition profiles 1 and 3 (Flue dust 1 and Flue dust 3) contains nickel sulfate with a content >=1 %. Thus, "Flue dust, precious metal refining" (Flue dust 1 and Flue dust 3) must be classified with regard to the described SCL values as STOT-RE 1 (H372, inhalation route) in accordance with Regulation (EC) 1272/2008.

Flue dust 2 may contain 1 - 10 % NiO and thus has to be classified for STOT-RE 1 (H372, inhalation route) as well in accordance with Regulation (EC) 1272/2008.