Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

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
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
other: software
Title:
Unnamed
Year:
2014

Materials and methods

Principles of method if other than guideline:
General grade
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.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Reasonable worst-case across industry, as reported in Section 1.2.
Representative sample for mineralogical information is provided in IUCLID Section 4.23.

Results and discussion

Effect levels
Dose descriptor:
other: acute toxicity estimate ATE
Effect level:
> 50 - <= 300 mg/kg bw
Based on:
test mat.
Remarks on result:
other: prediction

Any other information on results incl. tables

According to MeClas, the substance is classified as Acute toxicity Oral Category 3 - H301.

Based on this result, the related criteria provided the estimated value for acute toxicity-oral (Acute Toxicity Point Estimate) (see EU CLP Guidance Annex I Table 3.1.2): 100 mg/kg bodyweight.

Applicant's summary and conclusion

Conclusions:
Good quality estimate of the Acute Toxicity Estimate (ATE) -oral of the UVCB substance.
The substance is classified as acute toxic resulting in an ATE of 100 mg/kg bodyweight.
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.