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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

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Administrative data

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records
Reference
Endpoint:
toxicity to reproduction
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 considering reproduction toxicity (effects on male or female fertility) of "Residues, precious metal refining cementation" was determined by using the “Classification criteria for mixtures” of Regulation (EC) 1272/2006 section 3.7.3.1 “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
Reproductive 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:
"Residues, precious metal refining cementation" composition profile 1 (Residues 1) does not contain any constituent ≥ 0.3 % which possesses reproduction toxicity and/or induce effects on or via lactation. Hence, the substance must not be classified as reproductive toxicant.
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.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Effect on fertility: via inhalation route
Endpoint conclusion:
no adverse effect observed
Effect on fertility: via dermal route
Endpoint conclusion:
no adverse effect observed
Additional information

Substance specific information for the UVCB substance "Residues, precious metal refining cementation" is not available for the endpoint "Toxicity to Reproduction" with respect to effects on fertility. 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 a mixture classified as reproduction toxicants or for effects on or via lactation that trigger classification of the mixture" and respective rules of Regulation (EC) 1272/2006 section 3.7.3.1

Classification of mixtures when data are available for all ingredients or only for some ingredients of the mixture” with the MeClas tool.

In total two different grades of "Residues, precious metal refining cementation" (Residues 1 and Residues 2) were identified by the consortium. Thus, for "Residues, precious metals refining cementation" two C&L entries (i.e., no C&L (Residues 1) and classification for Repr. 1A (Residues 2)) for reproductive toxicity were calculated. Each group is described in a separate endpoint study record and endpoint summary.


Short description of key information:
No information on animal testing of "Residues, precious metal refining cementation" is available. Since, "Residues, precious metal refining cementation" composition profile 1 (Residues 1) does not contain any constituent ≥ 0.3 % which possesses reproduction toxicity potential and/or may induce effects on or via lactation, the substance must not be classified as reproductive toxicant. For information on C&L for "Residues, precious metal refining cementation" - composition profile 2 (Residues 2), please refer to the IUCLID endpoint summary "toxicity to reproduction - Residues, precious metal refining cementation (Residues 2).

Effects on developmental toxicity

Description of key information
No information on animal testing of "Residues, precious metal refining cementation" is available. Since, "Residues, precious metal refining cementation" composition profile 1 (Residues 1) does not contain any constituent ≥ 0.3 % which possesses reproduction/developmental toxicity potential and/or may induce effects on or via lactation, the substance must not be classified as reproductive toxicant. For information on C&L for "Residues, precious metal refining cementation" - composition profile 2 (Residues 2), please refer to the IUCLID endpoint summary "toxicity to reproduction - Residues, precious metal refining cementation (Residues 2).
Link to relevant study records
Reference
Endpoint:
developmental toxicity
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 considering reproduction toxicity (developmental toxicity) of "Residues, precious metal refining cementation" was determined by using the “Classification criteria for mixtures” of Regulation (EC) 1272/2006 section 3.7.3.1 “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
Abnormalities:
not specified
Developmental 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:
"Residues, precious metal refining cementation" composition profile 1 (Residues 1) does not contain any constituent ≥ 0.3 % which possesses reproduction/developmental toxicity potential and/or may induce effects on or via lactation. Hence, the substance must not be classified as reproductive toxicant.
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.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no adverse effect observed
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no adverse effect observed
Additional information

Substance specific information for the UVCB substance "Residues, precious metal refining cementation" is not available for the endpoint "Toxicity to Reproduction" with respect to effects on developmental 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 a mixture classified as reproduction toxicants or for effects on or via lactation that trigger classification of the mixture" and respective rules of Regulation (EC) 1272/2006 section 3.7.3.1 “Classification of mixtures when data are available for all ingredients or only for some ingredients of the mixture” with the MeClas tool.

In total two different grades of "Residues, precious metal refining cementation" (Residues 1 and Residues 2) were identified by the consortium. Thus, for "Residues, precious metals refining cementation" two C&L entries (i.e., no C&L(Residues 1) and classification for Repr. 1A (Residues 2)) for reproductive toxicity were calculated. Each group is described in a separate endpoint study record and endpoint summary.

Justification for classification or non-classification

Reproductive toxicity classification of UVCB substances is based on the presence of a constituent ≥ 0.3 % classified for reproductive toxicity. Since, "Residues, precious metal refining cementation" with the composition profile 1 (e.g., lead compounds <0.3%) is considered neither to induce reproductive toxicity nor induce effects on or via lactation, the substance does not have to be classified as such (neither Repr. 1A and Repr. 1B nor Repr. 2) in accordance with Regulation (EC) 1272/2008.

Additional information