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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)
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
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 inhalation toxicity potential of the UVCB substance was determined by classifying based on Mixture rules from EU CLP (additivity formula of classified components to derive hazard class) and back calculation to the corresponding acute toxicity range estimate.
GLP compliance:
no
Remarks:
other quality assurance was applied

Test material

Constituent 1
Reference substance name:
trichlorogold hydrate hydrochloride
EC Number:
933-944-5
IUPAC Name:
trichlorogold hydrate hydrochloride
Details on test material:
Elemental composition of maximum of typicals across industry: IUCLID Section 1.2

Results and discussion

Effect levels
Remarks on result:
other: Results determined based on elemental composition and T/D test

Applicant's summary and conclusion

Interpretation of results:
other: See
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The study provides a conservative estimate of the Acute Inhalation toxicity, derived on basis of the Classification outcome (Mixture toxicity rules) from a typical (across industry) concentration as defined in IUCLID section 1.2/1.4. See Section 2 for potential resulting classifications.

The result is applicable to all intermediates that fall under the defined concentration ranges (IUCLID section 1.2).
Executive summary:

The study provides a conservative estimate of the Acute Inhalation toxicity, derived on basis of the Classification outcome (Mixture toxicity rules) from a typical (across industry) concentration as defined in IUCLID section 1.2/1.4.

Validity of the model used:

  1. Defined end points:Acute toxicity-inhalation
  2. Unambiguous algorithm from EU CLP Guidance: additivity formula to determine classification, followed by back-calculation to related hazard criteria
  3. Applicability domain: applicable to classify complex metal containing materials. Available input information: elemental composition and representative mineralogical information (no correction for bio availability)
  4. Mechanistic interpretation - metal species:  the tool translates the elemental composition into a mineralogical composition relevant for classification (ie distribution pattern for each element/constituent of the UVCB substance). The classification is derived (by means of the Additivity formula) without taking into account any bio availability correction.  

Adequacy of prediction: the substance falls within the applicability domain described above and, therefore, the predicted value can be considered as reliable. The prediction is moreover conservative since only elemental composition and mineralogy is known, no bio elution data is available. Same conclusions apply to the prediction of the aquatic toxicity value.