Registration Dossier

Administrative data

Description of key information

No information on animal testing of "Residues, precious metal refining cementation" is available. However, "Residues, precious metal refining cementation" (Residues 1) with a lead and lead compound content of ~0.25% is considered to be toxic to specific target organs following repeated dose application via oral route and should be labelled with STOT-RE 2; H373 (specific concentration limits of lead compounds; see "justification for classification and non-classification" below), in accordance with Regulation (EC) 1272/2008. 

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 for cross-reference:
reference to same study
Reason / purpose for cross-reference:
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 "Residues, precious metal refining cementation" 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

„Residues, precious metal refining cementation“ is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of „Residues, precious metal refining cementation“ 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 “Residues, precious metal refining cementation”.

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 thespecific 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 drivers are identified for "Residues, precious metal refining cementation" (Residues 1) for the oral route:
(i):classification driver lead and lead compound (oral route, systemic effects)
(ii) classification driver selenium/selenium compounds (STOT-RE 2, oral route)

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 "Residues, precious metal refining cementation" with the composition profile 1 (Residues 1) includes lead/lead compounds with a content of ~0.25 % and selenium/selenium compounds (10 %), "Residues, precious metal refining cementation" (Residues 1) must be classified as STOT-RE 2 (oral route) and labelled with H373 in accordance with Regulation (EC) 1272/2008.
Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of "Residues, precious metal refining cementation", 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 for cross-reference:
reference to same study
Reason / purpose for cross-reference:
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 "Residues, precious metal refining cementation" 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

„Residues, precious metal refining cementation“ is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of „Residues, precious metal refining cementation“ 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 “Residues, precious metal refining cementation”.

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:
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 "Residues, precious metal refining cementation" with the composition profile 1 (Residues 1) does not meet the described criteria, "Residues, precious metal refining cementation" (Residues 1) must not be classified as STOT-RE via the inhalation route in accordance with Regulation (EC) 1272/2008.

Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of "Residues, precious metal refining cementation", 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:
no 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 "Residues, precious metal refining cementation" 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 two different grades of "Residues, precious metal refining cementation" (Residues 1and Residues 2) were identified by the consortium that could be grouped according to their calculated C&L resulting from the individual composition. Thus, for "Residues, precious metals refining cementation" two C&L entries (STOT RE 2, oral route (Residues 1) and STOT-RE 1 inhalation and oral route (Residues 2)) for repeated dose toxicity were calculated. Each group is described in a separate endpoint study record and endpoint summary.

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 %

Therefore, the following C&L driver were identified for Residues, precious metal refining cementation (Residues 1):

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

Residues – composition profile 1:

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 "Residues, precious metal refining cementation". Since "Residues, precious metal refining cementation" (Residues1) contains lead and lead compounds in concentrations relevant for C&L (lead compounds ≥0.05 % – < 0.5 %), "Residues, precious metal refining cementation" meets classification criteria for STOT-RE 2 (oral route) and requires labelling with H373 (may cause damage to organs), in accordance with Regulation (EC) 1272/2008.