Registration Dossier

Administrative data

developmental toxicity
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference Type:
other: software

Materials and methods

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:
other quality assurance was applied

Test material

Constituent 1
Reference substance name:
Leach residues, zinc ore, lead-contg.
EC Number:
EC Name:
Leach residues, zinc ore, lead-contg.
Cas Number:
silicon(4+) diiron(3+) dicopper(2+) hexazinc(2+) tetrahydrate hexahydroxide octaoxidandiide disulfate
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

Test animals

other: not tested

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

Clinical signs:
not examined

Effect levels (maternal animals)

Remarks on result:
not measured/tested
based on calculation

Results (fetuses)

Effect levels (fetuses)

Remarks on result:
not measured/tested
based on calculation

Fetal abnormalities

not examined

Overall developmental toxicity

Developmental effects observed:
not specified
Treatment related:
not specified

Any other information on results incl. tables

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

Applicant's summary and conclusion

Good quality study with result derived on basis of the Classification outcome (Mixture toxicity rules) from the reasinable worst case sample of the substance (maximum of typicals across industry as defined in IUCLID section 1.2/4.23). The analysed UVCB sample is classified for development toxicity.
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.