Scale (coating), copper

Toxicity to reproduction

Administrative data

Endpoint:

toxicity to reproduction

Remarks:

other: calculation based on mixture toxicity rules

Type of information:

calculation (if not (Q)SAR)

Remarks:

Migrated phrase: estimated by calculation

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No GLP but other quality assurance; software

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

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 UVCB substance as complex substance is classified regarding Toxicity to reproduction by applying rules for classification of mixtures (EU CLP guidance section 3.7.2 pg 322ff). The classification criteria (as set out in EU CLP Guidance Annex I: 3.7.1 pg 322) can be used to estimate effects derived from that classification/hazard.

GLP compliance:

no

Remarks:

other quality assurance

Test material

Test material information

Constituent 1

Reference substance name:

Copper scale grade 1

IUPAC Name:

Copper scale grade 1

Details on test material:

max across industry for Grade 1 as defined in IUCLID Section in 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 mixture rules resulted in "Reproductive toxicity: not classified"

Applicant's summary and conclusion

Conclusions:

Study can be used to determine Reproductive toxicity classifciation of the UVCB substance.

Executive summary:

The study provided a conclusive "Reproductive toxicity: not classified" of the UVCB sample, derived on basis of the classification mixture toxicity rules for a Grade 1 (max across industry) as defined under 1.2.

The result is therefore applicable to all Grade 1 Copper scales that fall under the therein defined concentration ranges.

The result is supported by (WoE) consideration from chemical and mineralogical information (IUCLID 4.23). In case of Grade 1 Scale/slag-type materials, the substance is a solid, and massive (only WC crushed sample show ca 40% below 20µm sized particulates, no other route than oral to consider). No significant amount (<0.1%) of repro tox species (eg Pb metal powder) could release, as predicted by results from sequential dissolution on Grade 1 representative samples . Water solubility test furthermore confirmed that the UVCB has low solubility, except for Si, Na, K, Ca and Cu where these constituents/species solubilised (at high loading of 5g/100ml and after ca. 14 -16 days) -none of these having Repro tox species.