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Description of key information

No information on animal testing of “Matte leaching residue" on acute toxicity is available. The C&L of “Matte leaching residue" composition profile 3 was determined by using the “acute toxicity range estimate (ATE)” and respective rules of Regulation (EC) 1272/2006 section 3.1.3.6 “Classification of mixtures based on ingredients of the mixture”.
 
Applying these rules the converted acute toxicity point estimate value for acute toxicity, oral route is 100 mg/kg bw in accordance with EU CLP Guidance Annex I Table 3.1.2. The converted acute toxicity point estimate value for acute toxicity, inhalation route is 1500 mg/m³ in accordance with EU CLP Guidance Annex I Table 3.1.2. For information on C&L for “Matte leaching residue" composition profile 1 & 2, please refer to the IUCLID endpoint summary "acute toxicity - “Matte leaching residue 1&2"

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
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:
Acute oral toxicity potential of the UVCB substance was determined by classifying based on Mixture rules from EU CLP (additivity formula of classified components to derive hazard class) and back calculation to the corresponding acute toxicity range estimate.
GLP compliance:
no
Remarks:
other quality assurance was applied
Dose descriptor:
other: Acute Toxicity Estimate (ATE)
Effect level:
> 50 - <= 300 mg/kg bw
Based on:
other: elemental composition
Remarks on result:
other: prediction

According to MeClas the substance is classified as acute toxic oral cat 3 - H301.

Conclusions:
The study provides a conservative estimate of the Acute Oral toxicity. The substance is classified as acute toxic- oral cat 3 - H301 under CLP.
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
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:
Acute inhalation toxicity potential of the UVCB substance was determined by classifying based on Mixture rules from EU CLP (additivity formula of classified components to derive hazard class) and back calculation to the corresponding acute toxicity range estimate.
GLP compliance:
no
Remarks:
other quality assurance was applied
Dose descriptor:
other: Acute Toxicity Estimate (ATE)
Effect level:
> 1 - <= 5 mg/L air
Based on:
other: elemental composition
Remarks on result:
other: prediction

According to MeClas the substance "Matte leaching residue" composition 3 is classified as acute toxicity inhalation category 4 - H332.

Conclusions:
The study provides a conservative estimate of the Acute Inhalation toxicity. The substance "Matte leaching residue" composition 3 is classified as acute toxicity inhalation category 4 H 332 under CLP.
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
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:
Acute dermal toxicity potential of the UVCB substance was determined by classifying based on Mixture rules from EU CLP (additivity formula of classified components to derive hazard class) and back calculation to the corresponding acute toxicity range estimate.
GLP compliance:
no
Remarks:
other quality assurance was applied
Dose descriptor:
other: Acute Toxicity Estimate (ATE)
Effect level:
> 2 000 mg/kg bw
Based on:
other: elemental composition
Remarks on result:
other: prediction

According to MeClas, the substance is not classified as Acute toxicity Dermal.

Conclusions:
The study provides a conservative estimate of the Acute Oral toxicity. The substance is not classified as acute toxic- dermal under CLP.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

Substance specific information for the UVCB “Matte leaching residue“ is not available for the endpoint "Acute 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 “acute toxicity range estimate (ATE)” and respective rules of Regulation (EC) 1272/2006 section 3.1.3.6 “Classification of mixtures based on ingredients of the mixture” with the MeClas tool.

In total three different “Matte leaching residue“ grades were identified by the consortium that could be grouped according to their calculated C&L resulting from the individual composition. Thus, for “Matte leaching residue“ one C&L entries for acute toxicity, oral (i.e., acute toxicity Acute Tox. 3) and two C&L entries for acute toxicity, inhalation (i.e., no C&L and Acute Tox. 4) were calculated. Each group is described in a separate endpoint study record and endpoint summary.

Justification for classification or non-classification

The available information indicates that “ Matte leaching residue" composition profile 3 is toxic via ingestion and inhalation, but not acutely toxic or harmful via the dermal route. “ Matte leaching residue" composition 3 requires classification as toxic if swallowed (Acute Tox. 3) and harmful if inhaled (Acute Tox. 4) according to Regulation (EC) 1272/2008. Classification of “ Matte leaching residue" composition 3 for acute toxicity via the dermal route is not required according to Regulation (EC) 1272/2008.

Specific target organ toxicant (STOT) - single exposure: oral, inhalation and dermal
The classification criteria according to Regulation (EC) 1272/2008 as specific target organs toxicant (STOT) – single exposure are not met since no adverse health effects, including reversible and irreversible, were observed immediately or delayed after exposure.