Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
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

Data source

Reference
Reference Type:
other: software
Title:
Unnamed
Year:
2010

Materials and methods

Principles of method if other than guideline:
Acute (inhalation) toxicity of the UVCB substance was determined by deriving classification 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 (inhalation) Toxicity criteria.
The classification criteria (as set out in EU CLP Guidance Annex I ) were used to estimate effects.
GLP compliance:
no
Remarks:
other quality assurance
Test type:
other: CLP calculation software

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Typical across industry as in IUCLID Section 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

Effect levels
Dose descriptor:
other: Acute toxicity estimate
Effect level:
> 5 mg/L air
Based on:
test mat.
Remarks on result:
other: prediction

Any other information on results incl. tables

The calculated classification via rules for mixtures (additivity, lower Tier) resulted in an "Acute Inhalation: Not classified"(Toxicity of all constituents > 1% w/w is known as of 1st ATP CLP and assessed metals).

Based on this result, the related criteria provided the estimated value for acute (inhalation) toxicity: Acute Toxicity Estimate > 5 mg/l

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Study can be used to predict an ATE and classification of the UVCB substance as a lower tier.
From the resuluts it is concluded that nickel slag is not to be classified for Acute toxicity by the inhalation route.
Executive summary:

The study provided a conservative (lower tier) estimate of the Acute Inhalation toxicity, derived on the basis of Classification outcome (Rules for mixtures) of a typical (across industry) nickel slag: ATE inhalation > 5 mg/l

The result is applicable to all nickel slags 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 Acute toxic species (such as Pb, As, Ni for example) demonstrate low solubility.

Result is further confirmed by extrapolation from oral to inhalation route based on worst case 100% absorption rate. 

Using ATE oral: 2000 mg/kg bw and the extrapolation formula 1mg/kgbw = 0.0052 mg/l/4h, the inhalation ATE will be 10.4mg/l/4h