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Administrative data

Endpoint:
two-generation reproductive toxicity
Type of information:
calculation (if not (Q)SAR)
Remarks:
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 for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
other: software
Title:
MECLAS: Metals Classification Tool, version V5.0
Author:
ARCHE Consulting
Year:
2018
Bibliographic source:
MECLAS webpage: www.meclas.eu
Report date:
2018

Materials and methods

Principles of method if other than guideline:
Reproductive 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.

Test material

Constituent 1
Reference substance name:
Slags, lead reverbatory smelting
EC Number:
273-800-2
EC Name:
Slags, lead reverbatory smelting
Cas Number:
69029-58-9
Molecular formula:
Molecular weight/formula concept not applicable to Inorganic UVCB (complex metal containing substance)
IUPAC Name:
Slags, lead reverbatory smelting
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 4.27.

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Remarks on result:
other: classification based on MeClas calculation
Remarks:
The substance has at least one component has reliable and good quality evidence of reprotoxic effects from human cases or epidemiological studies or animal studies.

Results: F1 generation

Effect levels (F1)

Remarks on result:
other: classification based on MeClas calculation
Remarks:
The substance has at least one component has reliable and good quality evidence of reprotoxic effects from human cases or epidemiological studies or animal studies.

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

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

Applicant's summary and conclusion

Conclusions:
Good quality study with result derived on basis of the Classification outcome (Mixture toxicity rules) from the reasonable worst case sample of the substance (maximum of typicals across industry as defined in IUCLID section 1.2/4.27). The analysed UVCB sample is classified for reproductive 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.

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