Registration Dossier

Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: calculation based on classification
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no GLP (but other Quality Assurance); software
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
other: software
Title:
Unnamed
Year:
2010

Materials and methods

Principles of method if other than guideline:
The potential of the UVCB substance as reproductive toxicant was established by classifying the complex metal substance according to rules for classification of mixtures for reproductive toxicity (EU CLP guidance section 3.7.3 pg 329ff). The classification criteria (as set out in EU CLP Annex I: 3.7.3.1.1 and Table 3.7.2.) can be used to estimate effects derived from that classification/hazard. In vitro bio-accessibility tests in solvent that resembles gastric fluid were performed according to ASTM D5517.07. The results are used to refine/confirm the hazard classification.
GLP compliance:
no
Remarks:
(other quality assurance)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Typical across industry as defined in IUCLID 1.2.

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

 

The classification is calculated via rules for mixtures.

Applicant's summary and conclusion

Conclusions:
Study can be used to predict the reproductive toxicity effect and to determine the reproductive toxicity hazard/classification of the UVCB substance
Executive summary:

Study can be used to predict the reproductive toxicity effect and to determine the reproductive toxicity hazard/classification of the UVCB substance .