Registration Dossier

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 tool in development at Eurometaux
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:
2010

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

Reference
Name:
Unnamed
Type:
Constituent
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

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 "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) nickel slag.

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

The result is applicable to all nickel 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 nickel slag does contain minor constituents classified as a reproductive toxicant Cat 1 (Pb compounds) at actual levels much lower than the threshold of 0.3%

To further confirm the classification in-vitro bio-accessibility tests in solvent that resembles gastric fluid was 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 reduced relative bio- accessibility of metals (Cu 0.04, Ni 0.05, Co0.06).Dissolved concentrations of Pb and As were below detection limit.

Therefore consideration of reduced bio-accessibility of Pb further confirm No classification of nickel slags for reproductive toxicity