Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc.

Endpoint summary

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 "Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc." 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

"Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc." is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of "Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc." 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 "Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc.".

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:

"Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc." (Reclaim 2 and Reclaim 3) contains lead and lead compounds ≥ 0.3 % whic is classified for reproduction toxicity (Repr. 1A, i.e., suspected of damaging fertility). Hence, "Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc." (Reclaim 2 and Reclaim 3) must be classified as reproductive toxicant Repr. 1A (H360Df).

Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of "Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc.", 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:

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 "Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc." 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 three different grades of "Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc." (Reclaim 1 – Reclaim 3) were identified by the consortium that could be grouped according to their calculated C&L resulting from the individual composition. Thus, for "Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc." two C&L entries (i.e., no C&L and classification for Repr. 1A) 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 "Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc." is available. However, "Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc." (Reclaim 2 and Reclaim 3) contains lead and lead compounds ≥ 0.3 % that may cause reproduction/developmental toxicity (i.e., may damage the unborn child). Hence, the substance (Reclaim 2 and Reclaim 3) must be classified as reproductive/developmental toxicant. For information on C&L for Reclaim 1 please refer to the respective IUCLID endpoint summary.

Effects on developmental toxicity

Description of key information

No information on animal testing of "Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc." is available. However, "Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc." (Reclaim 2 and Reclaim 3) contains lead and lead compounds ≥ 0.3 % that may cause reproduction/developmental toxicity (i.e., may damage the unborn child). Hence, the substance (Reclaim 2 and Reclaim 3) must be classified as reproductive/developmental toxicant. For information on C&L for Reclaim 1 please refer to the respective IUCLID endpoint summary.

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 "Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc." 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

"Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc." is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of "Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc."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 "Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc.".

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:

"Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc." (Reclaim 2 and Reclaim 3) contains lead and lead compounds ≥ 0.3 % that is classified for developmental/reproduction toxicity (Repr. 1A, i.e., may damage the unborn child). Hence, "Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc." (Reclaim 2 and Reclaim 3) must be classified as developmental/reproductive toxicant Repr. 1A (H360Df).

Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of "Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc.", 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:

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 "Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc." 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 three different grades of "Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc." (Reclaim 1 – Reclaim 3) were identified by the consortium that could be grouped according to their calculated C&L resulting from the individual composition. Thus, for "Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc." two C&L entries (i.e., no C&L and classification forRepr. 1A) for developmental toxicity were calculated. Each group is described in a separate endpoint study record and endpoint summary.

Justification for classification or non-classification

Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc. (Reclaim 2 and Reclaim 3):

Reproductive toxicity classification of UVCB substances is based on the presence of a constituent ≥ 0.3 % classified for reproductive toxicity. "Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc." (Reclaim 2 and Reclaim 3) contains lead and lead compounds ≥ 0.3 % (w/w). Hence, "Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc." (Reclaim 2 and Reclaim 3) is considered to cause reproductive/developmental toxicity, and should be classified as Repr. 1A (H360Df: may damage the unborn child, suspected of damaging fertility) in accordance with Regulation (EC) 1272/2008. No evidence on effects on or via lactation can be found for "Materials for reclaim, Precious Metals in Bricks, Pots, Crucibles and trays, etc.".