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Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

Toxicity to reproduction is driven by the characteristics of the individual UVCB constituents.
Relevant information on the individual UVCB constituents is reported in Section 7 Summary.

Link to relevant study records
Reference
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
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
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.
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.
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.
Reproductive effects observed:
not specified

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

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.

Effect on fertility: via oral route
Endpoint conclusion:
adverse effect observed
Additional information

Short description of key information:
Toxicity to reproduction (effect on fertility) is driven by the characteristics of the individual UVCB constituents.
Relevant information on the individual UVCB constituents is reported in Section 7 Summary.

Effects on developmental toxicity

Description of key information

Toxicity to reproduction (developmental toxicity) is driven by the characteristics of the individual UVCB constituents.
Relevant information on the individual UVCB constituents is reported in Section 7 Summary.

Justification for classification or non-classification