Registration Dossier

Administrative data

Endpoint:
reproductive toxicity, other
Remarks:
prediction from hazard class
Type of information:
calculation (if not (Q)SAR)
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:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
other: software
Title:
MECLAS (Metals Classification Tool, version V5.2) classification for Slimes and sludges, electrolytic tin refining
Author:
ARCHE Consulting
Year:
2018
Bibliographic source:
MECLAS webpage: www.meclas.eu
Report Date:
2018

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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder

Results and discussion

Results: P0 (first parental animals)

Effect levels (P0)

Dose descriptor:
other: reprotoxic effect
Basis for effect level:
other: Positive
Remarks on result:
not measured/tested
Remarks:
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.

Results: F1 generation

Effect levels (F1)

Dose descriptor:
other: reprotoxic effect
Generation:
other: not specified
Basis for effect level:
other: not specified
Remarks on result:
not measured/tested
Remarks:
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.

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 the reasinable worst case sample of the substance (maximum of typicals across industry as defined in IUCLID section 1.2/1.4). 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 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.