Lead, bullion

Respiratory sensitisation

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

other: software

Title:

Unnamed

Year:

2019

Materials and methods

Principles of method if other than guideline:

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

Test material information

Constituent 1

Reference substance name:

Lead, bullion

EC Number:

308-011-5

EC Name:

Lead, bullion

Cas Number:

97808-88-3

Molecular formula:

Molecular weight/formula concept not applicable to Inorganic UVCB (comlex metal containing substance)

IUPAC Name:

Lead, bullion

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 substance is not classified as Respiratory sensitiser.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

(Non-)classification based on MeClas calculation

Conclusions:

Good quality study with result derived on basis of the Classification outcome (Mixture toxicity rules) from the reasonable worst case sample of the substance (maximum of typicals across industry as defined in IUCLID section 1.2/4.27). The compositions considered are not classified for respiratory sensitisation.

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.