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Diss Factsheets

Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: calculation based on classification
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 for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
other: software
Title:
Unnamed
Year:
2019

Materials and methods

Principles of method if other than guideline:
The potential of the UVCB substance as reproductive toxicant (effects on fertility) was established by classifying the complex metal substance according to rules for classification of mixtures for reproductive toxicity (EU CLP guidance section 3.7.3 pg 329ff). The classification criteria (as set out in EU CLP Annex I: 3.7.3.1.1 and Table 3.7.2. ) can be used to estimate effects derived from that classification/hazard. In vitro bio-accessibility tests in solvent that resembles gastric fluid were performed according to ASTM D5517.07 . The results are used to refine/confirm the hazard classification
GLP compliance:
no
Remarks:
other quality assurance

Test material

Constituent 1
Reference substance name:
slag, copper smelting
EC Number:
266-968-3
Cas Number:
67711-92-6
IUPAC Name:
slag, copper smelting
Details on test material:
Typical across industry as defined in IUCLID 1.2;
See IUCLID Section 1.4, for company specific elemental composition; and representative sample for mineralogical information (IUCLID Section 4.23 -Outotec report)

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Key result
Remarks on result:
not measured/tested
Remarks:
calculated

Results: F1 generation

Effect levels (F1)

Key result
Remarks on result:
not measured/tested
Remarks:
calculated

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

The calculated classification via rules for mixtures (Lower Tier) resulted in “Reproductive toxicity: Category 1A” triggered by Pb compounds at actual levels above 0,3%.

Consideration of reduced bio-accessibility of Pb (Higher Tier) resulted in” Reproductive toxicity: Not classified” 

Applicant's summary and conclusion

Conclusions:
Study can be used to predict the reproductive toxicity effect (on fertility) and to determine the reproductive toxicity hazard/classification of the UVCB substance
Executive summary:

The study provided a conservative estimate of the Reproductive toxicity toxicity effect, derived on basis of the Classification outcome by applying the rules for mixtures of a Typical (across industry) copper slag.

It is concluded that slag, copper smelting is not to be classified for reproductive toxicity.

The result is applicable to all copper slags that fall under the defined concentration ranges (IUCLID section 1.2).

Chemistry of the substance (see IUCLID section 4.23 chemical and mineralogical characterization) shows that copper slag does contain minor constituents classified as a reproductive toxicant Cat 1 (Pb compounds) at actual levels above 0.3% but lower than 0.5%

Therefore to further refine the classification in-vitro bio-accessibility tests in solvent that resembles gastric fluid were performed according to ASTM D5517.07.(pH 1.5) The fraction of metals that solubilize under these conditions can be considered as worst case determinant of bio-accessibility of metals contained in the slag. (see section 7.1.1.Basic Toxicokinetics).

Results demonstrate low relative bio- accessibility of metals (Cu 0.06 – 0.2, Ni 0.09 – 0.33) and medium accessibility of Pb (0.13 – 0.74).

Furthermore, conclusions on bioavailability are supported the physical properties of the substance.

It can be demonstrated by the measurements that the maximum level of bio-accessible Pb in copper slag is below 0.3% (based on worst case release rate per different sample type)

Therefore consideration of reduced bio-accessibility of Pb lead to No classification of copper slags for reproductive toxicity.