Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
8 months
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies : not available
- Available non-GLP studies : not available
- Historical human data : not available
- (Q)SAR : not applicable for UVCB and inorganic substances
- In vitro methods : not available for this endpoint
- Weight of evidence : no sufficient information from independent sources
- Grouping and read-across : difficult to apply and justify for UVCB substances

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
None of the options for the data waiving for this endpoint in IUCLID is possible to use.

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.31 (Prenatal Developmental Toxicity Study)

Test material

Constituent 1
Reference substance name:
Ashes (residues), nonhazardous municipal solid waste
EC Number:
937-417-0
Molecular formula:
not applicable
IUPAC Name:
Ashes (residues), nonhazardous municipal solid waste
Test material form:
solid: bulk
Details on test material:
- Name of test material (as cited in study report): Ashes (residues), nonhazardous municipal solid waste
- Substance type: UVCB (inorganic oxides)
- Physical state: solid
- Composition of test material, percentage of components: SiO2 47.71 %; Al2O3 12.24 %; Fe2O3 9.62 %; CaO 15.80 %; Na2O 3.93 %; MgO 1.98 %; SO3 (total) 1.73 %; K2O 1.46 %; TiO2 1.22 %;
- Lot/batch No.: SPRUK-pololetí II/2010

Test animals

Species:
rat

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion