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Toxicological information

Respiratory sensitisation

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Administrative data

Endpoint:
respiratory sensitisation: in vitro
Remarks:
prediction 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-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:
2020

Materials and methods

Principles of method if other than guideline:
General Grade
Respiratory sensitisation potential of the UVCB potential 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:
Speiss, lead
EC Number:
282-366-3
EC Name:
Speiss, lead
Cas Number:
84195-61-9
Molecular formula:
Molecular weight/formula concept not applicable to Inorganic UVCB (complex metal containing substance)
IUPAC Name:
Speiss, lead
Details on test material:
Reasonable worst-case across industry, as reported in Section 1.2.
Representative sample for mineralogical information is provided in IUCLID Section 4.27.

Results and discussion

Any other information on results incl. tables

According to MeClas, the General Grade of the substance is classified as Respiratory sensitiser Cat 1 - H334

Applicant's summary and conclusion

Interpretation of results:
Category 1 (respiratory sensitising) based on GHS criteria
Remarks:
This classification applies only to General Grade, not to Grade 2 (which, according to MeClas, is not classified)
Conclusions:
Good quality study with result derived on basis of the classification outcome (mixture toxicity rules) from a conservative, worst-case sample of the substance (max. of max for As, Cd, Co, Pb, Ni, Sb, and max. of typicals for other elements) across industry as defined in IUCLID section 1.2/4.27 for all grades, using mineralogical information from the representative sample.
Executive summary:

The study provided a conservative estimate, derived on basis of the classification outcome (mixture toxicity rules) from a Classification was based on a conservative, worst-case sample of the substance (max. of max. for As, Cd, Co, Pb, Ni, Sb, and max. of typicals for other elements, across industry as defined in IUCLID section 1.2/4.27), 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.

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