Speiss, lead

Toxicity to reproduction

Administrative data

Endpoint:

two-generation reproductive toxicity

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:

2020

Materials and methods

Principles of method if other than guideline:

Reproductive 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:

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

Results: P0 (first parental generation)

Effect levels (P0)

Remarks on result:

other: classification based on MeClas calculation

Results: F1 generation

Effect levels (F1)

Remarks on result:

other: classification based on MeClas calculation

Overall reproductive toxicity

Reproductive effects observed:

not specified

Any other information on results incl. tables

According to MeClas, the substance is classified as Reproductive Tox. Cat. 1 - H360.

Applicant's summary and conclusion

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), using mineralogical information from the representative sample. The analysed UVCB sample is classified for reproductive toxicity.

Executive summary:

The study provided a conservative estimate, 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), 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.