Registration Dossier

Diss Factsheets

Toxicological information

Repeated dose toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
repeated dose toxicity: inhalation, other
Remarks:
predicted from hazard class
Type of information:
calculation (if not (Q)SAR)
Remarks:
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:
2014

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
Chemical structure
Reference substance name:
Nickel
EC Number:
231-111-4
EC Name:
Nickel
Cas Number:
7440-02-0
Molecular formula:
Ni
IUPAC Name:
nickel
Constituent 2
Chemical structure
Reference substance name:
Cobalt
EC Number:
231-158-0
EC Name:
Cobalt
Cas Number:
7440-48-4
Molecular formula:
Co
IUPAC Name:
cobalt(2+)
Constituent 3
Chemical structure
Reference substance name:
Lithium
EC Number:
231-102-5
EC Name:
Lithium
Cas Number:
7439-93-2
Molecular formula:
Li
IUPAC Name:
lithium
Constituent 4
Chemical structure
Reference substance name:
Aluminium
EC Number:
231-072-3
EC Name:
Aluminium
Cas Number:
7429-90-5
Molecular formula:
Al
IUPAC Name:
aluminum
Test material form:
solid: particulate/powder
Details on test material:
Composition represents the lowest and highest possible concentration of each individual constituent in NCA (estimated by Monte Carlo simulation, taking into account the following ranges of variability:
Sum of of Ni+Co+Al = approx. 1
Li =0.9-1.3
Ni: 0.75-0.99
Co: 0.01-0.2
Al: 0.01-0.2
A more detailed composition can be provided by the data holder, but is not defined in this record as this represents sensitive business information that cannot be shared with co-registrants. The composition, however, fits into the agrees Substance Identity Profile.

Results and discussion

Effect levels

Key result
Dose descriptor:
other: target organ toxicity
Basis for effect level:
other: at least one component has reliable and good quality evidence from human cases or epidemiological studies or animal studies with significant and/or severe toxic effects at low exposure concentrations
Remarks on result:
not measured/tested
Remarks:
Effect level not specified

Target system / organ toxicity

Key result
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:
The assessment of the repeated dose toxicity properties of NCA is based on the repeated dose toxicity properties of its constituents (oxide forms of Al, Co, Li, Ni) (Assessment Entity Approach)
A reliable assessment, based on the CLP mixture rules and using the MeClas Classification Tool, was conducted on a generic NCA sample (composition based on worst-case concentrations for each constituent, as defined in IUCLID section 1.2). According to MeClas, the assessed generic NCA composition 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.