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Registration Dossier
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EC number: 310-050-8 | CAS number: 102110-49-6
Endpoint summary
Administrative data
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
- 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
- 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.
Reference
According to MeClas the substance is classified as acute toxic oral cat 3 - H301.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
Acute toxicity: via inhalation route
Link to relevant study records
- 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
- 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.
Reference
According to MeClas the substance "Matte leaching residue" composition 3 is classified as acute toxicity inhalation category 4 - H332.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
Acute toxicity: via dermal route
Link to relevant study records
- 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
- 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.
Reference
According to MeClas, the substance is not classified as Acute toxicity Dermal.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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