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Administrative data

Endpoint:
repeated dose toxicity: inhalation
Remarks:
other: predicted from hazard class
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-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
other: software
Title:
Unnamed
Year:
2015

Materials and methods

Principles of method if other than guideline:
Repeated dose toxicity potential of the UVCB 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:
Matte, nickel
EC Number:
273-749-6
EC Name:
Matte, nickel
Cas Number:
69012-50-6
Molecular formula:
Not applicable
IUPAC Name:
Nickel matte
Details on test material:
Compositions Tested:

Nickel Sulphidic Matte with Copper >8% (including Cobalt 0.1 -<1%)

Nickel Sulphidic Matte with Copper >8% (including Cobalt ≥1 - <3%)

Nickel Sulphidic Matte (including Cobalt 0.1 -<1%)

Nickel Sulphidic Matte (including Cobalt ≥1 - <3%)

Nickel Metallic Matte (including Cobalt 0.1 -<1%)

Nickel Metallic Matte (including Cobalt ≥1 - <3%)

Nickel Metallic Matte (including Cobalt ≥3%)

Reasonable worst-case speciations across industry, as reported in Section 1.2.

Results and discussion

Effect levels

Dose descriptor:
other: target organ toxicity
Basis for effect level:
other: at least one component with animal studies with significant and/or severe toxic effects at generally low exposure concentrations
Remarks on result:
not measured/tested
Remarks:
Effect level not specified (migrated information)

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

According to MeClas, the substance is classified as STOT-RE Cat. 1 - H372.

Applicant's summary and conclusion

Conclusions:
Good quality study with result derived on basis of the Classification outcome (Mixture toxicity rules) from the reasinable worst case sample of the substance (maximum of typicals across industry as defined in IUCLID section 1.2/4.23). The analysed UVCB sample is classified for STOT-RE Cat. 1.
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.

STUDY RATED BY AN INDEPENDENT REVIEWER