Residues, copper-iron-lead-nickel matte, sulfuric acid-insol.

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records

Reference

Endpoint:

two-generation reproductive toxicity

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: Automatic calculation with MeCLas tool

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:

Reproductive potential of the UVCB potential was determined by classifying based on Mixture rules from EU CLP (additivity formula of classified components to derive hazard class). The classification criteria were used to estimate effects.

GLP compliance:

no

Remarks:

other quality assurance was applied

Remarks on result:

not measured/tested

Remarks on result:

not measured/tested

Remarks on result:

not measured/tested

Remarks on result:

not measured/tested

Reproductive effects observed:

not specified

 According to MeClas, the substance is classified as Reproductive Tox. Cat. 1A - H360.

Conclusions:

The study provides a conservative estimate of reproductive toxicity. The analysed UVCB sample is classified as Reproductive Tox. Cat. 1A - H360.

Executive summary:

The study provided a conservative estimate, derived on basis of the classification outcome (mixture toxicity rules) from a reasonable worst-case sample of the substance using mineralogical information from the representative sample.    Validity of the model used: 1. Defined endpoint: the endpoint is a REACH compliant defined endpoint 2. Unambiguous algorithm: EU CLP guidance based summation formula to determine classification, followed by back-calculation to related hazard criteria 3. Applicability domain: applicable to classify complex metal containing materials.  4. Mechanistic interpretation - metal species: the tool translates the elemental composition into a mineralogical composition relevant for classification.

Effect on fertility: via oral route

Endpoint conclusion:

adverse effect observed

Effect on fertility: via dermal route

Endpoint conclusion:

no adverse effect observed

Additional information

Substance specific information for the UVCB substance “Matte leaching residue" 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 “Matte leaching residue" were identified by the consortium that could be grouped according to their calculated C&L resulting from the individual composition.However, for “Matte leaching residue" only one C&L entry (i.e., reproductive toxicant Repr. 1A) for reproductive toxicity was generated, since all composition profiles contains lead and lead compounds ≥ 0.3 % relevant for C&L as Repr. 1A.

Short description of key information:
No information on animal testing of “Matte leaching residue" is available. However, “Matte leaching residue" contains lead and lead compounds ≥ 0.3 % that may possess reproduction toxicity potential (i.e., suspected of damaging fertility). However, “Matte leaching residue" also contains nickel sulfate classified as reproductive toxicant “Repr. 1B” (H360) with a content ≥ 0.3 %. Nevertheless, the classification driver for “Matte leaching residue" is lead and lead compounds that requires classification as reproductive toxicant “Repr. 1A” (H360).

Effects on developmental toxicity

Description of key information

No information on animal testing of “ Matte leaching residue"  is available. However, “Matte leaching residue" contains lead and lead compounds ≥ 0.3 % that may possess reproduction toxicity potential (i.e., may damage the unborn child). However, “Matte leaching residue" also contains nickel sulfate classified as reproductive toxicant “Repr. 1B” (H360) with a content ≥ 0.3 %. Nevertheless, the classification driver for “Matte leaching residue" is lead and lead compounds that requires classification as reproductive toxicant “Repr. 1A” (H360).

Link to relevant study records

Reference

Reference 1

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: Automatic calculation with MeClas tool

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:

Developmental potential of the UVCB potential was determined by classifying based on Mixture rules from EU CLP (additivity formula of classified components to derive hazard class). The classification criteria were used to estimate effects.

GLP compliance:

no

Remarks:

other quality assurance was applied

Species:

other: MeClas calculation tool used

Remarks on result:

not measured/tested

Remarks on result:

not measured/tested

Developmental effects observed:

not specified

According to MeClas the substance is classified as Developmental Tox. Cat. 1 - H360

Conclusions:

The study provides a conservative estimate of developmental toxicity. The analysed UVCB sample is classified as Developmental Tox. Cat. 1 - H360.

Executive summary:

The study provided a conservative estimate of the effect concentration, derived on basis of the classification outcome (mixture toxicity rules) from a reasonable worst-case sample of the substance using mineralogical information from the representative sample. 

 

Validity of the model used:

1. Defined endpoint: the endpoint is a REACH compliant defined endpoint

2. Unambiguous algorithm: EU CLP guidance based summation formula to determine classification, followed by back-calculation to related hazard criteria

3. Applicability domain: applicable to classify complex metal containing materials. 

4. Mechanistic interpretation - metal species: the tool translates the elemental composition into a mineralogical composition relevant for classification.

Reference 2

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: Automatic calculation with MeClas tool

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:

Developmental potential of the UVCB potential was determined by classifying based on Mixture rules from EU CLP (additivity formula of classified components to derive hazard class). The classification criteria were used to estimate effects.

GLP compliance:

no

Remarks:

other quality assurance was applied

Species:

other: MeClas tool

Remarks on result:

not measured/tested

Remarks on result:

not measured/tested

Developmental effects observed:

not specified

According to MeClas the substance is classified as Developmental Tox. Cat. 1 - H360

Conclusions:

The study provides a conservative estimate of developmental toxicity. The analysed UVCB sample is classified as Developmental Tox. Cat. 1 - H360.

Executive summary:

The study provided a conservative estimate of the effect concentration, derived on basis of the classification outcome (mixture toxicity rules) from a reasonable worst-case sample of the substance using mineralogical information from the representative sample. 

 

Validity of the model used:

1. Defined endpoint: the endpoint is a REACH compliant defined endpoint

2. Unambiguous algorithm: EU CLP guidance based summation formula to determine classification, followed by back-calculation to related hazard criteria

3. Applicability domain: applicable to classify complex metal containing materials. 

4. Mechanistic interpretation - metal species: the tool translates the elemental composition into a mineralogical composition relevant for classification.

Effect on developmental toxicity: via oral route

Endpoint conclusion:

adverse effect observed

Effect on developmental toxicity: via dermal route

Endpoint conclusion:

adverse effect observed

Additional information

Substance specific information for the UVCB substance “ Matte leaching residue" 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 “ Matte leaching residue" were identified by the consortium that could be grouped according to their calculated C&L resulting from the individual composition.However, for “ Matte leaching residue" only one C&L entry (i.e., reproductive toxicant Repr. 1A) for reproductive toxicity was generated, since all composition profiles contains lead and lead compounds ≥ 0.3 % relevant for C&L as Repr. 1A.

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 of “ Matte leaching residue" contains lead and lead compounds (Repr. 1A) and nickel sulfate (Repro. 1B) ≥ 0.3%. Hence, “ Matte leaching residue" is considered to induce reproductive toxicity, and requires classification as Repr. 1A (H360Df: may damage the unborn child, suspected of damaging fertility) based on lead and lead compounds in accordance with Regulation (EC) 1272/2008. There is not any evidence of effects on or via lactation for any constituents of “ Matte leaching residue." at a concentration ≥ 0.3 %.