Scale (coating), copper

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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: 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:

Acute (oral) toxicity of the UVCB substance was determined by classifying based on Mixture rules from EU CLP (summation and/or additivity of classified components to derive Hazard class) and back calculation to the corresponding Acute (oral) Toxicity criteria

GLP compliance:

no

Remarks:

equivalent Quality assurance

Test type:

other: CLP calculation software

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Details on test material:

Typical (and max) across industry as in IUCLID 1.2 Scale/slag-type Grade 1 materials;
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

Effect levels

Dose descriptor:

other: ATE (acute Toxicity estimate)

Effect level:

> 300 - <= 2 000 mg/kg bw

Based on:

dissolved

Remarks on result:

other: prediction

Any other information on results incl. tables

The calculated classification via Additivity method (lower Tier Arche CLP Tool) resulted in an "Acute toxicity: Category 4 H302" classification for the UVCB substance Copper Scale Grade 1 (driven by Cu(I)O content): toxicity of all constituents > 1% w/w is known s of 1st ATP CLP and assessed metals.

Based on this result, the related criteria provided the estimated value for acute (oral) toxicity: Acute Toxicity Point Estimate : 300< ATE < or = 2000 mg/kg body weight.

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Study can be used to predict a ATE and classification of the UVCB substance as a lower tier (in absence of bio availability data).

Executive summary:

The study provided a conservative (lower tier) estimate of the Acute Oral toxicity, derived on basis of the Classification outcome (Mixture toxicity rules) from a typical (and max across industry) Copper Scale Grade 1 as defined in IUCLID section 1.2/1.4/4.23.

The result is applicable to all Copper scale Grade 1 that fall under the defined concentration ranges (IUCLID section 1.2).

The result is furthermore supported by (WoE) consideration from chemical & mineralogical information (IUCLID 4.23) showing that significant amount of Acute toxic species such as Cu(I)/Cu2O could be released in significant amounts as predicted by results from sequential dissolution via P2 (H2SO4) in all representative samples of Grade 1. 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) -with pH observed remaining at ca 9 or ca 7 (ie not exceeding to extremes >2 or >11,5).