Registration Dossier

Administrative data

Description of key information

The acute toxicity is driven by the characteristics of the individual UVCB constituents.
Relevant information on the individual UVCB constituents is reported in Section 7 Summary.

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)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Automatic calculation with MeClas tool
Reason / purpose:
reference to same study
Reason / purpose:
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.
Dose descriptor:
other: acute toxicity estimate ATE
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: prediction

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

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not classified as acute toxic.
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

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Automatic calculation with MeClas tool
Reason / purpose:
reference to same study
Reason / purpose:
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.
Dose descriptor:
other: Acute Toxicity Estimate (ATE)
Effect level:
> 1.5 mg/L air
Based on:
test mat.
Remarks on result:
other: prediction
Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not classified as acute toxic inhalation.
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

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Automatic calculation with MeClas tool
Reason / purpose:
reference to same study
Reason / purpose:
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 the Mixture rules from EU CLP (additivity formula of classified components to derive hazard class) and back calculation to the corresponding acute toxicity range estimate.
Dose descriptor:
other: acute toxicity estimate ATE
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: prediction

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

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not classified as acute toxic dermal.
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

Additional information

Justification for classification or non-classification